- VIPES is the largest clinical study designed to assess efficacy and safety of Viaskin® Peanut epicutaneous immunotherapy (EPITTM) of peanut allergy
- DBV confirms it will report VIPES 12-month topline results in October 2014
BAGNEUX, France, July 17, 2014 (GLOBE NEWSWIRE) -- DBV Technologies, (Euronext: DBV - ISIN: FR0010417345), creator of Viaskin®, a new paradigm for the treatment of food allergies, announced today that the last patient in its phase IIb 'VIPES' study (VIaskin® Peanut's Efficacy and Safety) has completed the last food challenge visit after 12 months of treatment. Additionally the VIPES study drop-out rate was only at 6.4%, far below the 15% drop-out rate initially anticipated. DBV confirms that it will report VIPES 12-month topline results in October 2014 through a press release.
The first patient in VIPES was enrolled on July 31st 2012. VIPES is a Double-Blind, Placebo-Controlled, Randomized Phase IIb dose-finding trial to study VIaskin® Peanut's Efficacy and Safety in peanut allergy. In this trial, 221 peanut-allergic patients including children (113), adolescents (73) and adults (35) were included. The trial was conducted in Europe and North America by 22 investigators. Viaskin® Peanut development program was granted Fast Track designation by the Food and Drug Administration ('FDA').
The objectives of this 12-month dose-finding study with Viaskin® Peanut were as follows:
- In terms of efficacy, analysis of the desensitizing effect of each of the 3 active treatment doses (50 µg, 100 µg and 250 µg) versus placebo. Efficacy of desensitization is defined as the difference of success rate of a treatment arm versus placebo. Success per patient is objectivized by the ability to consume symptom-free a significant higher amount of peanut after 12 months of treatment;
- In terms of safety, analysis of the frequency, duration and severity of Adverse Events triggered by Viaskin® Peanut versus placebo.
The Principal Coordinating Investigator for North America is Hugh Sampson, M.D., Professor of Pediatrics and Director of The Jaffe Food Allergy Institute at Mount Sinai School of Medicine. In Europe, the Principal Coordinator is Christophe Dupont, M.D, Ph.D., Necker Sick Children's Hospital, Paris, France.
Pierre-Henri Benhamou, M.D., Chairman and CEO of DBV Technologies said: "We are reporting a major milestone in our history today, and we are extremely proud to be the first company ever to have successfully conducted such a large global clinical trial in peanut allergy immunotherapy. No other specialty pharmaceutical company has ever achieved what DBV is currently in the process of demonstrating: safely treat peanut-allergic patients. Viaskin® represents a real hope for millions of patients suffering from life-threatening allergies. We are more and more confident that we will bring to these patients the new standard of care in food and pediatric allergies."
Subjects enrolled in VIPES were proposed to continue in an open-label follow-up study of VIPES (OLFUS-VIPES). Subjects who completed the VIPES study will receive an additional 24 months of Viaskin® Peanut treatment followed by a 2-month period without treatment in order to assess the level of sustained tolerance. OLFUS-VIPES study is at the same sites. From the 207 subjects who completed VIPES, 170 decided to continue into OLFUS-VIPES (82%), confirming their high interest and satisfaction with Peanut EPITTM to treat their peanut-allergy.
About DBV Technologies
DBV Technologies is developing Viaskin®, an innovative new approach to the treatment of allergies - a major public health issue that is constantly increasing in prevalence. Food allergies represent a true handicap in everyday life for millions of people, constituting a major unmet medical need. DBV Technologies, incorporated in France in 2002, has developed a proprietary, worldwide-patented technology for administering an allergen to intact skin while avoiding transfer to the blood. The Viaskin® technology combines efficacy and safety as part of a treatment that seeks to improve the patient's tolerability of peanuts, and thus considerably lowers the risk of a systemic, allergic reaction in the event of accidental exposure The product's clinically proven safety profile enables the application of effective desensitization techniques in the most severe forms of the allergy. DBV Technologies is focusing on food allergies, including milk and peanut, for which there are currently no effective treatments. DBV Technologies has designed two products: Viaskin® Peanut and Viaskin® Milk. The clinical development program for Viaskin® Peanut has received Fast Track designation from the US Food and Drug Administration and is currently being studies in Phase II program. The company will subsequently develop a Viaskin® patch for young children with house dust mite allergy - a true public health issue because this pathology is a primary risk factor for childhood asthma.
DBV Technologies shares are traded on segment C of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345).
For more information on DBV Technologies, please visit our website: www.dbv-technologies.com
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DBV Completes last "food challenge" visit of last Patient http://hugin.info/156437/R/1828890/634066.pdf