Press releases

Positive CHMP opinion for the extension of indication of Palforzia® for the treatment of toddlers with confirmed peanut allergy

Baar (Switzerland), December 2, 2024 - Stallergenes Greer, a biopharmaceutical company specialising in allergen immunotherapy (AIT), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive opinion for the extension of the existing indication for Palforzia® (defatted powder of Arachis hypogaea L., semen (peanuts)) to the treatment of toddlers (ages 1 to 3) with a confirmed diagnosis of peanut allergy. If the extension indication is granted by the European Commission, Palforzia® will become the first EMA approved oral immunotherapy (OIT) treatment for toddlers living with confirmed peanut allergy.

 

Palforzia® is designed to gradually increase the body’s ability to tolerate small amounts of peanut (desensitisation) through carefully controlled and supervised initial dose escalation, up-dosing and maintenance. The extension of the indication, with adjustment of contraindications, would enable treatment to be initiated at an earlier age, thus offering young children and their families the opportunity to reduce the risk of severe allergic reactions from accidental exposure to peanut allergens.¹

The CHMP recommendation is under review by the European Commission which is responsible for the grant of central marketing authorisations in the European Union. If granted, the marketing authorisation would cover all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein and Norway). In July 2024, the U.S. Food and Drug Administration (FDA) approved the extension indication of Palforzia® for use in toddlers.

The regulatory submission is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.²

“The positive recommendation of Palforzia® marks a significant step forward for younger children with peanut allergy, as well as for their families. This milestone builds on Stallergenes Greer’s long-standing commitment to delivering innovative solutions for the benefit of allergy sufferers,” says Elena Rizova, Chief Medical Officer, Stallergenes Greer.

As Stallergenes Greer advances efforts to broaden access to Palforzia®, the company remains committed to offering solutions tailored to patient needs. With a comprehensive portfolio which includes oral immunotherapy for food allergy, tablet and liquid sublingual solutions, and subcutaneous formulations for respiratory and insect venom allergies, Stallergenes Greer is paving the way for personalised, precision-based allergen immunotherapy.

 

 

ABOUT PALFORZIA®

Palforzia® is indicated by the European Medicine Agency (EMA) in the European Union, by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland for the treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy. Palforzia® may be continued in patients 18 years of age and older. Palforzia® should be used in conjunction with a peanut-avoidant diet.

Palforzia® is also approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy; Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 year of age and older. Palforzia is to be used in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

 

Stallergenes Greer acquired the rights to Palforzia^® in September 2023.

 

 

ABOUT POSEIDON PHASE 3 STUDY

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia® in peanut-allergic children aged 1 to 3 years of age in North America and Europe.

The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia® to Stallergenes Greer in September 2023.

Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.

In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).

 

ABOUT STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com.

 

 

CONTACT

Communications

Catherine Kress

Tel: +33 (0)1 55 50 26 05

Email: catherine.kress@stallergenesgreer.com

 

 

1.Summary of Product Characteristics. Rev 06 Sep 2024

FDA approves U.S. pediatric indication extension for Palforzia® oral immunotherapy for the treatment of peanut allergy

Baar (Switzerland), July 30, 2024 – Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, today announced that the U.S Food and Drug Administration (FDA) has approved Palforzia^® [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy. This approval expands the January 2020 FDA approval for patients ages 4-17 years. Palforzia^® is to date the first and only approved oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut.

Peanut allergy currently affects approximately 2% of the general population of Western nations¹, and the prevalence of peanut allergy doubled among children between 2005 and 2015². Compared with other food allergies, peanut allergy is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis¹. The difficulty in avoiding peanuts, combined with the severity of allergic reactions, shows the need for effective treatment³.

“We are delighted that Palforzia^® has received regulatory approval in the U.S. for toddlers as there is a high unmet medical need for this age group and we are confident that this indication extension will alleviate the burden of peanut allergy for younger patients and their families,” says Elena Rizova, MD, PHD, Chief Medical Officer of Stallergenes Greer.

The FDA approval in toddlers is based on data from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia^® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile.

Stallergenes Greer acquired the rights to Palforzia^® in September 2023. As part of our ongoing commitment to delivering innovative solutions in allergen immunotherapy, our focus in the U.S has been on establishing a specialised Food Allergy business unit and transitioning the product into our AIT portfolio.

 

ABOUT PALFORZIA^®

Palforzia^® is in the U.S an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy and in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

Palforzia^® is approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years and for ages 4-17 years by the European Medicine Agency (EMA), by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland. Pediatric indication extension submissions are currently under review by the EMA and Swissmedic.

 

ABOUT POSEIDON PHASE 3 STUDY

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia^® in peanut-allergic children aged 1 to 3 years of age in North America and Europe.

The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia^® to Stallergenes Greer in September 2023.

Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge.

In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia^® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC).

 

ABOUT STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com.

 

 

CONTACT

 

Stallergenes Greer                                                                      

Communications                                                                                                            

Catherine Kress                                                                                                                              

Tel: +33 (0)1 55 50 26 05                                                                

Email: catherine.kress@stallergenesgreer.com                  

 

 

 

¹ The global burden of illness of peanut allergy: A comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. Online: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247890/. Accessed August 31, 2023

² Du Toit G, et al. Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372: 803-

13. Accessed August 31, 2023.

³ Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3. Accessed August 31, 2023.

 

 

Palforzia®: © 2023, Société des Produits Nestlé S.A. or its affiliates

 

Stallergenes Greer showcases new data for food and respiratory immunotherapy at 2024 EAACI Congress

Baar (Switzerland), May 31, 2024 – Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy (AIT), hosted today a company-sponsored symposium entitled "Allergen harmony": New data for a tailored and sustained food and respiratory immunotherapy effect at the 2024 European Academy of Allergy and Clinical Immunology (EAACI) Congress taking place May 31-June 3 in Valencia (Spain).

During the symposium, five of the world’s leading experts in respiratory and food allergy discussed three key points to reach harmony when treating allergic patients with AIT, from deciphering the science behind immunotherapy treatments to maximise the chances of effectiveness, understanding the impact of patient profile diversity on AIT response and the importance of ensuring patients’ adherence to treatment to favour sustained and disease-modifying benefits.  

“Stallergenes Greer is committed to meeting patient needs for precise, personalised allergen immunotherapy treatments by delivering high-quality products adapted to individual disease profiles. We work closely with the medical community, and advocate for appropriate treatment use and adherence to ensure long-lasting clinical benefits which improve the quality of life of patients,” stated Dr Elena Rizova, Chief Medical Officer, Stallergenes Greer.

During the congress, Stallergenes Greer will also present 21 abstracts and announce new data from clinical studies (EfficAPSI, PRACTIS, BREATH, POSEIDON).

 

COMPANY SPONSORED SYMPOSIUM (May 31: 13:45–14:45)

“Allergen harmony”: New data for a tailored and sustained food and respiratory immunotherapy effect

Chairs: Prof. Tomás Chivato, Spain; Prof. Giorgio Walter Canonica, Italy

- “Picking the harmony”: The science behind immunotherapy treatments

   Speaker Prof. Alessandro Fiocchi, Italy

- “Tuning in”: Patient profiles orchestrating optimised response to immunotherapy

   Speaker Dr. Katharina Blümchen, Germany

- “Rhythm of success”: Sustaining benefits in allergen immunotherapy

   Speaker Dr. Davide Caimmi, France

 

 

ABOUT STALLERGENES GREER STUDIES EfficAPSI¹ PRACTIS², BREATH^3,4,5,6, POSEIDON⁷

 

EfficAPSI is to date the largest retrospective real-world, longitudinal cohort study regarding liquid sublingual AIT (SLIT) treatment.¹ Its main objective was to evaluate the real-life impact of SLIT-liquid on the prevention of asthma onset and worsening in patients with allergic rhinitis. This study included more than 110,000 patients in France with allergic rhinitis with or without asthma treated with Stallergenes Greer’s SLIT-liquid and symptomatic drugs and more than 330,000 patients with allergic rhinitis with or without asthma treated with symptomatic drugs only. The EfficAPSI study evaluated data from January 1, 2010 to December 31, 2018. 

 

In patients undergoing treatment Stallergenes Greer’s SLIT-liquid and symptomatic drugs versus patients treated with symptomatic drugs only, the study showed:

• a 36% reduction in the risk of new asthma events in the overall cohort
• a 38% reduction in the risk of asthma onset in patients without pre-existing asthma
• a one-third reduction in Global Initiative for Asthma (GINA) treatment stepping-up, in patients with pre-existing asthma demonstrating the impact of SLIT-liquid to prevent asthma worsening.¹

 

The EfficAPSI study covers a wide range of allergens including house dust mites, grass, birch, ragweed pollens, and cat dander. Results were positive and consistent for all analysable allergens and all age groups (above the age of 5).

 

PRACTIS is a French multicentre real-world observational prospective one-year study.² It included over 1,000 allergic children, adolescents and adults treated in current practice with SLIT (liquid and tablet formulations) to evaluate the patients’ expectations and short-term benefits (after 6-12 months) achieved with SLIT according to the modalities of use, through the patient benefit index (PBI, scale 0-4) based on two questionnaires, a PBI score ≥1 being considered as clinically relevant.

 

The study showed that approximately 90% of treated patients with allergic rhinitis with or without asthma with or without conjunctivitis benefited from SLIT (PBI score ≥1), regardless of their age (above the age of 5), the causal allergen and mono or polyallergic status.² Notably more than half of them showed a PBI score equal to or greater than 2.5. The treatment duration had no impact on the benefit perceived by patients receiving SLIT with mite and grass pollen allergens which were the most frequently used in the study. SLIT was well-tolerated with 4% of adverse reactions, mostly gastro-intestinal disorders such as oral pruritus or mouth oedema.

 

The BREATH (Bringing Real-World Evidence to Allergy Treatment for Health) real-world evidence programme, sponsored by Stallergenes Greer, was designed to gather real-world data about the benefits of AIT on allergic rhinitis and asthma progression as well as asthma onset through the analysis of associated symptomatic medication dispensation.^3,4,5 The BREATH studies reviewed prescription data for a variety of AIT products, including Stallergenes Greer’s SLIT-tablet with a mix of five grass pollen allergen extracts (from Cocksfoot, Sweet vernal grass, Rye grass, Meadow grass and Timothy) currently authorised in more than 30 countries around the world, including most of the countries within Europe, the United States, Canada, Australia, and Russia for the treatment of grass pollen allergic rhinitis, and Stallergenes Greer’s SLIT-liquid, currently available in more than 40 countries, including most of the countries within Europe, for the treatment of allergy involving rhinitis, conjunctivitis, rhino-conjunctivitis or asthma (mild to moderate) of a seasonal or perennial nature, in adults and children (from the age of 5 year). Stallergenes Greer’s SLIT-liquid is not approved in the U.S.

 

The BREATH programme demonstrated a significant reduction in allergic rhinitis (AR) and asthma medication dispensation up to 6 years post-treatment cessation in over 3,900 patients with grass pollen allergy treated with SLIT tablets and in over 9,000 patients with birch family pollen allergy treated with AIT. In addition, results showed a significant decrease in the risk of new asthma medication dispensation in allergic rhinitis patients without asthma at study entry.^3,4,5 In a post hoc analysis, 3-tree (birch/alder/hazel) pollen SLIT-liquid showed significant real-world benefits during treatment and up to 6 years post-treatment cessation in patients with birch family pollen-induced allergic rhinitis and/or asthma, preventing AR and asthma progression as well as new development of asthma.⁶

 

POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomised (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of defatted powder of Arachis Hypogaea L., semen (peanut) or PDAH, in peanut-allergic children aged 1 to less than 4 years of age in North America and Europe.⁷ The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested the product to Stallergenes Greer in September 2023. Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge (DBPCFC). In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of PDAH or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit DBPCFC.

 

This study showed that in 98 peanut-allergic children 1 to <4 years of age treated for approximately 12 months compared with 48 children receiving placebo, 68.4% of PDAH patients vs. 4.2% of placebo patients tolerated at least 1,000 mg of peanut protein with no more than mild allergic symptoms at exit challenge. Treated patients had more treatment-related adverse events, which were of mild to moderate severity.⁷

 

ABOUT THE EAACI CONGRESS

The European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more than 15,000 members from 124 countries and over 50 National Allergy Societies, EAACI is the primary source of expertise in Europe and worldwide for all aspects of allergy.

 

ABOUT STALLERGENES GREER

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the research, development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information: www.stallergenesgreer.com

 

CONTACT

 

Stallergenes Greer                                                                                  

Communications                                                                              

Catherine Kress                                                                               

Tel: +33 (0)1 55 50 26 05                                                                

Email: catherine.kress@stallergenesgreer.com                       

Stallergenes Greer Foundation announces winners of 2023 Science Awards for Allergy

 

Baar (Switzerland), May 27, 2024 – The Stallergenes Greer Foundation, dedicated to fostering innovation and precision medicine in the field of allergy, is delighted to announce the recipients of the 2023 edition of its prestigious Science Awards for Allergy. These awards recognise outstanding contributions to allergy research and environmental health initiatives and allocate up to €150,000 to support these efforts.

After thorough review of the 45 high-level applications by the Foundation’s Scientific Board and Managing Board, the following researchers have been selected as recipients:

Innovation Awards

• Rising Talent Category:

Assoc. Prof. Jennifer Koplin, Group Leader, Childhood Allergy & Epidemiology, Child Health Research Centre, The University of Queensland, Australia, recognised for her research: “Association between earlier introduction of peanut and prevalence of peanut allergy in infants in Australia” will receive €25,000.

Assoc. Prof. Rachel Peters, Principal Research Fellow, Murdoch Children's Research Institute, Australia, recognised for her research: “Multiple food allergy phenotypes in infancy are associated with lung function deficits and asthma at 6 years of age: a prospective cohort study in Australia” will receive €25,000.

• Mid-Career Scientist Category:

Assoc. Prof. Jenny Hallgren Martinsson, Senior Lecturer in Immunology, Department of Medical Biochemistry and Microbiology, Uppsala University, Sweden, recognized for her research: “Circulating mast cell progenitors increase during natural birch pollen exposure in allergic asthma patients” will receive €25,000.

Dr Luciana Kase Tanno, Researcher, University Hospital of Montpellier, France, recognised for her research: “Changing the history of anaphylaxis mortality statistics through the World Health Organization's International Classification of Diseases 11” will receive €25,000.

Environmental Health Award

Dr Dorra Gharbi, Post doctoral research fellow, Allergology and Immunology Unit, Lung Institute, University of Cape Town, South Africa, recognised for her research: “Allergenic tree pollen in Johannesburg and Cape Town as a public health risk: Towards a sustainable implementation framework for South African cities” will receive €50,000.

Michele Antonelli, CEO of Stallergenes Greer and Chairman of the Stallergenes Greer Foundation, expresses his congratulations to the award recipients. “These researchers exemplify the spirit of innovation and dedication that the Stallergenes Greer Foundation seeks to promote. Their work not only advances our understanding of allergies but also brings us closer to creating healthier futures for all. These grants contribute to nurturing the next generation of researchers, in line with the foundation’s core mission of supporting academic endeavors aimed at fostering future leaders in allergy healthcare.”

The Scientific Committee, composed of a panel of international renowned experts:

• Pascal Demoly, Professor of Pulmonology and Head of Department at the University Hospital of Montpellier (France)
• Alessandro Fiocchi, MD, Director of Allergy at Pediatric Hospital Bambino Gesù, Rome, (Vatican City)
• Carla Irani, Associate Professor, Internal Medicine and Clinical Immunology, Allergology - Immunological Asthma at Hôtel Dieu de France University Medical Center, Beirut (Lebanon)
• Kari Nadeau, MD, PhD, Chair of the Department of Environmental Health at Harvard T.H. Chan School of Public Health, Boston (MA, U.S.A.)

highlighted the comprehensive coverage of allergy research of these awards, spanning public health with international classification of diseases, clinical science in asthma, and epidemiology in food allergy and aerobiology. The members also noted that these awards present an outstanding opportunity to highlight the importance of allergy research while tackling the increasing prevalence of allergic disease across the globe.

The Stallergenes Greer Foundation extends its gratitude to all applicants and acknowledges the invaluable contribution of the Scientific Board in the selection process.

The next Science Awards will be announced in 2025.

 

About the research projects

Jennifer Koplin’s research uses large-scale population-based studies to advance the understanding of childhood food allergy. These studies contribute to the development of novel prevention interventions and are helping to target emerging prevention and treatment strategies for the individuals who will benefit most from these interventions. Her innovative work with the EarlyNuts study evaluated the uptake and impact of early peanut introduction on peanut allergy, not only showing that population-level changes in infant feeding practices are possible, but also contributing to reshaping clinical and public health guidelines, and inspiring novel clinical trials internationally.

Soriano VX, et al: Association Between Earlier Introduction of Peanut and Prevalence of Peanut Allergy in Infants in Australia. JAMA. 2022 Jul 5;328(1):48-56. https://pubmed.ncbi.nlm.nih.gov/35788795/

 

Rachel Peters’ research aims to reduce the adverse consequences of infant food allergy – affecting up to 10% of children worldwide – on children’s future health. Through a pioneering study on the link between childhood food allergy and respiratory health, she uncovered that infants with food allergy, even if it resolves, present with lung function deficits and a higher risk of asthma by school age. These findings are sparking greater clinical vigilance regarding the monitoring of respiratory health of children with food allergies and will support clinicians worldwide in tailoring patient care.

Peters RL. Soriano VX, Lycett K, et al: Multiple food allergy phenotypes in infancy are associated with lung function deficits and asthma at 6 years of age: a prospective cohort study in Australia. The Lancet child & adolescent health 2023 Sep;7(9):636-647 .https://pubmed.ncbi.nlm.nih.gov/37506717/

Jenny Hallgren Martinsson’s research interest is to determine the role of mast cells—immune cells responsible for immediate allergic reactions—in allergic asthma. Her recent cutting-edge study on birch pollen-sensitized asthma patients and mast cell biology suggests that mast cell progenitors may play a pathogenic role in allergic asthma, thus paving the way for the development of new biomarkers and treatment targets for asthma.

P Abigail Alvarado-Vazquez et al, Circulating mast cell progenitors increase during natural birch pollen exposure in allergic asthma patients Allergy. 2023 Nov;78(11):2959-2968. doi: 10.1111/all.15860. Epub 2023 Aug 24 https://pubmed.ncbi.nlm.nih.gov/?term=Alvarado-Vazquez+PA&cauthor_id=37615432

Luciana Kase Tanno dedicated her career to epidemiology research to support public health and preventive actions, more particularly focusing on hypersensitivity conditions such as anaphylaxis. Leveraging a detailed academic and evidence-based action plan, her work helped in reviewing the current International Classification of Diseases to provide greater visibility to allergic and hypersensitivity conditions. Her efforts and commitment will further ensure that patients may benefit from the best management strategy throughout the world.

Kase Tanno et al, Changing the history of anaphylaxis mortality statistics through the World Health Organization's International Classification of Diseases 11.” J Allergy Clin Immunol. 2019 Sep;144(3):627-633. doi: 10.1016/j.jaci.2019.05.013. Epub 2019 Jun 20. https://pubmed.ncbi.nlm.nih.gov/31229269/

Dorra Gharbi’s research focuses on aerobiology, air quality and environmental health. Her transdisciplinary work is enhancing our understanding of how climate, environmental exposures (aeroallergens) and intrinsic factors intersect to impact respiratory health outcomes. Her efforts to investigate a phenomenon in a specific setting “allergenic pollen-producing trees within the context of urban green infrastructure in South African cities”, to inform a wider inquiry regarding the health risk for the South African population, as well as the management thereof in a sustainable implementation framework. The outcome of this research opens the possibility of designing early warning systems to predict community-level surges in poor respiratory health outcomes and be able to provide allergy management plans to prevent allergic reactions.

Gharbi, D., Neumann, F.H., Cilliers, S. et al. Allergenic tree pollen in Johannesburg and Cape Town as a public health risk: towards a sustainable implementation framework for South African cities. Discov Sustain 4, 32 (2023). https://doi.org/10.1007/s43621-023-00151-9

 

About the Stallergenes Greer Foundation

The Stallergenes Greer Foundation, under the aegis of the Fondation de France, is a non-profit foundation whose aim is to build healthier futures for all. The Stallergenes Greer Foundation pursues a comprehensive approach calling for “the collaborative efforts of multiple disciplines working locally, nationally, and globally, to attain optimal health for people, animals and our environment”, as defined by the One Health initiative.

 

About the Fondation de France

Created in 1969, Fondation de France is a private organisation recognised of public interest, whose mission is to support all forms of generosity and translate them into effective actions of general interest. With close to 1,000 hosted foundations, the Fondation de France supports more than 10,000 promising and innovative initiatives each year, in France and abroad. Independent and private, it operates thanks to the generosity of donors.

 

CONTACT

Stallergenes Greer Foundation                                                                                                                                               

Catherine Kress

Secretary General

Tel: +33 (0)1 55 50 26 05                                                        

Email: catherine.kress@stallergenesgreer.com                    

 

 

 

 

Stallergenes Greer publishes in The Lancet regional Health-Europe landmark EfficApsi real-world study confirming significant benefit of its liquid sublingual AIT on the onset and progression of allergic asthma

• EfficAPSI is a real-world study with the largest number of patients follow-up to date in the field of allergen immunotherapy (AIT)¹
• The rigorous methodology used in this study provides important insights about Stallergenes Greer SLIT-liquid as allergic asthma disease-mofifying medicine¹
• In this study, treatment with Stallergenes Greer SLIT-liquid was associated with a one-third reduction in the incidence of new asthma events in patients, with or without a history of asthma.¹
• The findings confirm the real-life long-term effectiveness of personalised SLIT-liquid for the treatment of allergic rhinitis patients (above the age of 5), with and without pre-existing asthma, regardless the allergen. They substantiate SLIT-liquid as a relevant causal treatment option to prevent both asthmatic disease onset and progression.¹
• By demonstrating the benefit on the onset and worsening of asthma, SLIT-liquid treatments confirm their impact in terms of public health.¹ 

 

 

Baar (Switzerland), May 2, 2024 – Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that results of its EfficAPSI real-world study evaluating the impact of Stallergenes Greer liquid sublingual AIT (SLIT-liquid) on asthma onset and evolution in patients with allergic rhinitis have been published in the Lancet Regional Health-Europe. The publication is available online (https://doi.org/10.1016/j.lanepe.2024.100915) and will be available in print at a later date.  

This retrospective longitudinal pharmaco-epidemiological real-world study, which evaluated data over a 9-year period, included over 440,000 patients: more than 110,000 patients with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid and symptomatic drugs; compared to more than 330,000 patients with allergic rhinitis, with or without asthma, treated with symptomatic drugs only.

The primary objective of the study was the evaluation of the real-world impact of Stallergenes Greer SLIT-liquid on the prevention of asthma onset or worsening in patients with allergic rhinitis. Study results were consistent across all age groups (patients above the age of 5), allergens and endpoints.

In patients undergoing treatment with Stallergenes Greer SLIT-liquid and symptomatic drugs versus patients treated with symptomatic drugs only, the study showed:

• a 36% reduction in the risk of new asthma events in the overall cohort*;
• a 38% reduction in the risk of asthma onset in patients without pre-existing asthma;
• a one-third reduction in Global Initiative for Asthma (GINA) treatment stepping-up, in patients with pre-existing asthma demonstrating the impact of SLIT-liquid to prevent asthma worsening.

“I am pleased that the publication of this extensive, large real-world EfficAPSI study in the Lancet Regional Health-Europe is now available for the medical community. The study confirms the role of SLIT- liquid in reshaping asthma management. The findings deliver important insights on the relevance of SLIT liquid as etiological medication which offers the advantage of a personalised treatment tailored to each patient's unique needs for improved outcomes,” said Professor Pascal Demoly, MD, PhD, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France), President of the French Society of Allergology, and member of the study’s scientific committee.

“Exploring the impact of allergen immunotherapy on asthma onset and progression is crucial, and we're committed to filling those gaps. Through this real-world EfficAPSI study, Stallergenes Greer is honoured to contribute valuable scientific evidence and insights to allergy treatment. We remain focused on advancing disease-modifying solutions, fuelled by strong clinical data, to redefine respiratory care, and dedicated to improving quality of life for people with allergies” declared Dr Elena Rizova, Chief Medical Officer, Stallergenes Greer.

By demonstrating the benefit on the onset and worsening of asthma, Stallergenes Greer SLIT-liquid treatments confirm their impact in terms of public health. Stallergenes Greer intends to increasingly use a real-world approach to bolster the evidence supporting the beneficial effects of SLIT. Additional endpoints are currently under evaluation and will be published subsequently.

 

ABOUT EfficAPSI ¹

EfficAPSI is to date the largest retrospective real-world, longitudinal cohort study regarding liquid sublingual AIT. Its main objective was to evaluate the real-life impact of SLIT-liquid on the prevention of asthma onset and worsening in patients with allergic rhinitis. This study included more than 110,000 patients in France with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid and symptomatic drugs and more than 330,000 patients with allergic rhinitis, with or without asthma, treated with symptomatic drugs only. The EfficAPSI study, evaluated data from January 1, 2010 to December 31, 2018. 

EfficAPSI is the first study in the AIT field in which the French national system database (SNDS), covering 99% of the French population, has been used to gain insight on therapeutic benefits in real life practice by pairing their data with the data of a healthcare company. 

Onset or worsening of asthma were defined as the first occurrence of a specific pharmacy dispensation, hospitalisation or long-term disease (LTD) for asthma in the sensitive analysis; pharmacy dispensation was omitted for a more specific, secondary definition, focusing on severe forms of asthma. A combined definition, both sensitive and specific, was also used considering specific pharmacy dispensation of major medications (omalizumab or three inhaled corticosteroids associated or not with long-acting beta agonists), hospitalisation or LTD for severe asthma. Analyses were stratified on pre-existing mild or moderate asthma to differentiate between the onset and worsening of asthma.

A total of 112,492 exposed (SLIT-liquid) and 333,082 unexposed patients (control) were included.

Findings on new asthma events: in allergic rhinitis patients, Stallergenes Greer SLIT-Liquid exposure was associated with a significantly lower risk of new asthma events, when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.76, 95% CI 0.75-0.76; specific, HR: 0.66, 95% CI 0.63-0.69; combined, HR: 0.64, 95% CI 0.63-0.65).

Findings on onset of asthma: in allergic rhinitis patients without pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma onset when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.77, 95% CI 0.76-0.78; specific, HR: 0.67, 95% CI 0.61-0.72; combined, HR: 0.62, 95% CI 0.60-0.63).

Findings on worsening of asthma: in allergic rhinitis patients with pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma events when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.71, 95% CI 0.70-0.72; specific, HR: 0.62, 95% CI 0.59-0.65; combined, HR: 0.62, 95% CI 0.61-0.63). In addition, a one-third reduction in GINA treatment stepping-up was observed regardless of patients’ GINA treatment step at baseline (HR: 0.72, 95% CI 0.69-0.75 for baseline step 1; HR: 0.73, 95% CI 0.68-0.79 for baseline step 2; HR; 0.71, 95% CI 0·65-0·78 for baseline step 3/4).

The EfficAPSI study covers a wide range of allergens including house dust mites, grass, birch and ragweed pollens, and cat dander. Results were positive and consistent for all analysable allergens and all age groups (above the age of 5).

The study was designed with a scientific committee composed of Prof. Pascal Demoly, MD, PhD, HDR, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France); Prof. Philippe Devillier, Hôpital Foch, Suresnes (France); Prof. Jean François Bergmann, Head of Internal Medicine, Hôpital Lariboisière, Paris, Professor of Therapeutics, Paris-Diderot University (France);  Dr. Bertrand Delaisi, Boulogne-Billancourt (France), and Prof. Mathieu Molimard, Head of the Pharmacology Department, Bordeaux University Hospital (France).

 

 

 

ABOUT ALLERGIC RHINITIS

Allergic rhinitis is a worldwide disease affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population. Allergic rhinitis can include symptoms such as sneezing, a runny or itchy nose, nasal congestion and watery or itchy eyes, among others.^2,3  Symptoms may be severe and can worsen over time and have a significant impact on quality of life.^2,4,5,6,7 

 

ABOUT STALLERGENES GREER INTERNATIONAL AG

Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com.

 

 

 

CONTACT

 

Stallergenes Greer                                                                                  

Communications                                                                                                                 

 

Catherine Kress                                                                                                                            

Tel: +33 (0)1 55 50 26 05                                                             

Email: catherine.kress@stallergenesgreer.com                  

 

*combined score