Stallergenes Greer announces Positive top-line results of Phase 3 study for pediatric House Dust Mite-induced allergic rhinitis
Stallergenes Greer (the “Company”) (Euronext Paris: STAGR) (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced positive topline results for a Phase 3 clinical study of its sublingual immunotherapy tablet (STG320) for the treatment of house dust mite (HDM) induced allergic rhinitis in the pediatric population, which was conducted in Japan by its partner Shionogi & Co. Ltd.
The multi-center, randomized, double-blind and placebo-controlled study evaluated the efficacy of STG320 at a daily dose of 300IR administered for 12 months to children between 5 and 16 years old with HDM-associated allergic rhinitis and achieved its primary efficacy endpoint. The active group demonstrated a statistically significant difference (p=0.0005) on the Average Adjusted Symptom Score (AAdSS) after one year of treatment versus placebo and the results will be used to obtain approval from Japan’s Pharmaceutical and Medical Device Agency (PMDA) in the pediatric population.
“We are pleased with the outcome of this study, which brings us another step closer to providing access to this therapy for children living with house dust mite-induced allergic rhinitis in Japan,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “This data increases our understanding of STG320’s clinical profile and will enable us, in the future, to generate appropriate evidence packages which support registration in those markets where ACTAIR® can provide a valuable new therapeutic option.”
In September 2010, Stallergenes SA signed exclusive partnership agreements with Shionogi & Co., Ltd. for the clinical development, registration and commercialization of sublingual house dust mite and Japanese cedar pollen immunotherapy tablets. As part of this, the Company is eligible for development, regulatory and sales milestones, as well as royalty payments on net sales.
ABOUT THE STG320 PHASE 3 TRIAL
The primary endpoint was the AAdSS over the last month of the one year treatment period. The AAdSS is the average of the total score of four rhinitis symptoms (sneezing, rhinorrhea, nasal congestion and nasal pruritus) adjusted for rescue medication use. This was a multi-center, randomized, double-blind and placebo-controlled study to assess the efficacy of house dust mite sublingual immunotherapy tablets for the treatment of perennial allergic rhinitis. Patients aged 5 to 16 years old with medical history consistent with house dust mite-induced allergic rhinitis were eligible. A total of 438 patients were randomized to receive 12 months of treatment with house dust mite sublingual immunotherapy tablets or placebo. The active group showed statistically significant difference (p=0.0005) compared to placebo. Local adverse reactions were observed, with most of them mild in nature with no marked safety concerns.
ABOUT RESPIRATORY ALLERGIES IN JAPAN
Allergic rhinitis affects 25% of Japan’s population. House dust mites and Japanese cedar pollen are the two main causes of respiratory allergies in this country. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a natural progression towards asthma. The symptoms may be severe, significantly impairing patients’ quality of life. With 32 million respiratory allergy sufferers, there is a strong, and as yet unmet, demand for allergy treatment in Japan where sublingual allergen immunotherapy tablets have not been available.
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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