Stallergenes Greer announces completion of enrollment in largest phase III study to treat house dust mites allergy
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announced today that it completed enrollment in a pivotal Phase III clinical study to evaluate the safety and efficacy of its investigational sublingual immunotherapy tablet STG320 for the treatment of house dust mite (HDM) induced allergic rhinitis. The study recruited over 1,600 patients from 13 countries with 231 participating investigative sites, and is the largest study of its kind. Principal investigators are Pascal Demoly, MD, from University Hospital of Montpellier, France, and the President of the French Allergy Federation, and Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida.
“This is the largest study undertaken to measure the efficacy of sublingual immunotherapy (SLIT) treatment against HDM-induced allergic rhinitis and this study has the potential to bring more options for patients,” said Professor Casale. “In the United States, subcutaneous immunotherapy treatment for patients with allergic rhinitis is administered through injections at the doctor’s office; the tablet formulation offers an effective alternative treatment option for patients that may prefer oral administration at home.”
“Our aim is to bring innovation to patients suffering from HDM-induced allergic rhinitis, one of the most prevalent allergies in the world4. Completion of patient enrollment in this pivotal study is a significant milestone for Stallergenes Greer towards achieving this goal,” said Fereydoun Firouz, CEO of Stallergenes Greer. “We are committed to our purpose – to enable people with allergies to live normal lives – and continue to focus on developing evidence based solutions to prevent and treat all allergies.”
This Phase III study, together with other clinical data, will form the company’s submission for a Biologics License Application (BLA) in the United States planned for 2019 and for additional marketing authorizations in European and international markets. To date, the product is already approved for commercialisation in Japan, Australia and South Korea.
ABOUT THE STG320 STUDY
The study is global, multi-center, randomized, double-blind and placebo controlled. It evaluates the safety and efficacy of STG320 at a daily dose of 300IR administered to adult and adolescent patients aged 12-65 with HDM-induced allergic rhinitis. Patients who experienced HDM-associated allergic rhinitis for at least one year, who are sensitized to D. pteronyssinus and/or D. farinae mites as defined on a skin prick test and HDM-specific serum immunoglobulin E, were eligible for participation.
ABOUT HOUSE-DUST MITE INDUCED ALLERGIC RHINITIS
Allergic rhinitis is a worldwide disease affecting over 500 million people and the risk of developing asthma is about six times higher in patients with allergy to House Dust Mites (HDM) than those allergic to pollens1-4. Allergic rhinitis can include symptoms such as sneezing, runny nose, wheezing, cough, itching, and watery/itchy eyes, among others1,2. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma1-3,5-8.
Symptomatic treatments such as antihistamines and nasal corticosteroids provide only temporary relief to patients1,8. The primary therapeutic goals of allergy immunotherapy (AIT) include reducing symptoms, reducing symptomatic medication use, and improving allergy-related quality of life. The evidence is strong that AIT achieves these goals and can alter the course of the disease, with benefits persisting in many patients for several years after treatment discontinuation1,2,10-16.
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of GREER Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com.
This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2015 annual report published on 29 April 2016 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.
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