Clinical development
Our objective is the development of pharmaceutical specialties aimed at treating the major respiratory allergies. Going beyond our current areas of expertise, we are investigating the therapeutic potential of new clinical indications and demonstrate further evidence of Stallergenes Greer AIT treatments beyond clinical trials.
Stallergenes Greer is committed to improving health and quality of life for patients. Clinical trials are designed to provide evidence that a treatment is both safe and effective and produce high-quality data for decision-making.
Staloral®: 30 double-blind, placebo-controlled studies; 3,200 patients enrolled in total. The studies aimed to evaluate the tolerability and efficacy of Staloral® for the treatment of allergic rhinitis and asthma in the short- and long-term, as well as after stopping the treatment, in children and adults.
Oralair®: full clinical development; more than 2,500 patients enrolled. The studies evaluated the tolerability and efficacy of Oralair® after one month, in the short- and long-term and after the treatment has ended.
Actair®: full clinical development; more than 3,500 patients enrolled. The studies evaluated the tolerability and efficacy of Actair® after four months, in the short-term as well as one year after the treatment has ended.
Bringing Real-World Evidence to Allergy Treatment for Health
Further evidence of Stallergenes Greer AIT treatments beyond clinical trials is demonstrated through real-world studies.
Stallergenes Greer is sponsoring the BREATH (Bringing Real-World Evidence to Allergy Treatment for Health) real-world evidence programme and is the first company in the AIT industry to bring global data to physicians and payers based on actual physician and patient experiences. This programme is designed to gather real-world data about the benefits of allergen immunotherapy (AIT, or desensitization) for allergic patients.
The BREATH studies review prescription data for a variety of AIT products, including Stallergenes Greer’s products and deepens our knowledge and understanding of real-life patient outcomes outside of a clinical setting.
The BREATH studies have been designed by a dedicated scientific committee of allergologists, pharmacoepidemiologists and pneumologists from multiple countries, and utilize large prescription databases, visualizing real-life patient treatments. These databases provide us with the unique opportunity to follow a long patient treatment history. Patients can be faced with a life-long burden of disease1 , therefore providing data on the long-term impact of AIT for allergy is paramount.
Rather than being a replacement for AIT Real Clinical Trial studies (RCT), which are gold standard studies, Real World Evidence complements clinical trial studies by investigating variables that are typically controlled for or excluded (such as comorbidities, lifestyles or demographics), are cost-restrictive, or where multiple study arms are not possible. It can provide us with additional insights, from both the physician and the patient perspectives. 2
1. Papadopoulos NG, et al. Clin Transl Allergy. 2012. 2:21.
2. Sherman R, et al. N Engl J Med, 2016. 375(23), 2293-2297 and Mahajan R. Int J App Basic Med Res. 205. 5(2), 82