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DBV Technologies Announces Positive Topline Safety Results from REALISE Phase III Trial of Viaskin Peanut for the Treatment of Peanut-Allergic Patients | |||
By: Nasdaq / GlobeNewswire - 20 Nov 2017 | Back to overview list |
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DBV Technologies Announces Positive Topline Safety Results from REALISE Phase III Trial of Viaskin Peanut for the Treatment of Peanut-Allergic Patients
Blinded period evaluated the safety of Viaskin Peanut versus placebo in children four to 11 years of age, Including patients with a history of severe anaphylaxis
These results, which are part of a global Phase III program, will support planned regulatory discussions for Viaskin Peanut DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT) today announced positive topline results from the Phase III REALISE (REAL Life Use and Safety of EPIT) trial. The REALISE double-blinded period compared the safety of treatment with Viaskin Peanut 250 µg versus placebo for six months. Patients who completed the blinded portion of the study will continue to receive active treatment for up to 36 months during an open-label extension, further studying the long-term safety and use of Viaskin Peanut in routine clinical practice. The REALISE trial met its primary objective, demonstrating that Viaskin Peanut was well-tolerated with no new or unexpected adverse events. Based on preliminary analysis, a similar safety profile was observed in all patients included in the trial, regardless of history of severe anaphylaxis. The safety data reported today complete the Food and Drug Administration (FDA) safety database requirement for the Viaskin Peanut program in children four to 11 years of age. Results from this study, in addition to data from the PEPITES Phase III efficacy and safety trial, will form the basis for planned regulatory discussions in the United States, Europe and other countries for use of Viaskin Peanut in this patient population. Dr. Jacqueline Pongracic , Head, Allergy and Immunology, Ann & Robert H. Lurie Children's Hospital of Chicago, Professor of Pediatrics and Medicine, Northwestern University Feinberg School of Medicine, and Principal Investigator of REALISE, said: " As more patients are treated with Viaskin Peanut in clinical trials, our understanding of this novel immunotherapy has deepened. In REALISE, we have observed that using the skin to activate the immune system of these patients resulted in a favorable safety and tolerability profile, likely contributing to the high compliance rate maintained throughout the blinded portion of the trial. The medical community has been eagerly anticipating a treatment that could be effective in real-life, and I am excited to have been part of this groundbreaking clinical program, which may bring us one step closer to meeting patients' needs."
Results from this trial were comparable with outcomes from previous studies of Viaskin Peanut
"For the millions of patients and their caregivers who cope with the tremendous burden of this disease daily, offering not only an effective medicine, but one that is safe is so essential," said Dr. Jim Baker , Chief Executive Officer and Chief Medical Officer, Food Allergy Research & Education (FARE). "The data from the six-month period of this trial underscores the favorable safety profile of Viaskin Peanut, which has also been observed in previous clinical studies. We look forward to seeing the long-term results from the rest of this trial and understanding the benefit of this potential treatment for patients." To date, over 700 patients have been studied in the Company's ongoing Phase III program in children ages four to 11, which includes both the PEPITES and REALISE trials. A Phase III trial is also ongoing in children one to three years of age. "We remain steadfast in our commitment to bringing a treatment to peanut-allergic patients as soon as possible," said Dr. Pierre-Henri Benhamou , Chairman & Chief Executive Officer of DBV Technologies. "This trial, which was the first Phase III trial to study peanut-allergic patients in the absence of food challenges, is an important consideration in understanding the use of Viaskin Peanut in a real-life setting. We are hopeful that data generated from REALISE will continue to strengthen the profile of Viaskin Peanut in routine clinical use." Detailed results from this study are expected to be submitted for presentation at a future medical meeting.
About REALISE
About PEPITES
During PEPITES, patients' response has been assessed using a double-blind, placebo controlled food challenge (DBPCFC). Patients were randomized 2:1 to receive either Viaskin Peanut 250 mcg or placebo for 12 months. The primary endpoint was based on a responder analysis after 12 months of treatment with Viaskin Peanut 250 µg. For patients with a baseline peanut protein eliciting dose (ED) equal to or less than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 300 mg of peanut protein after 12 months of treatment. For patients with a baseline ED greater than 10 mg, a responder was defined as a patient with a peanut protein ED equal to or greater than 1,000 mg of peanut protein after 12 months of treatment. As a secondary efficacy endpoint, Cumulative Reactive Dose (CRD), has also been used in PEPITES to establish the total quantity of peanut protein that triggers patient reactions at month 12 of active treatment versus placebo. Serological markers were also measured at baseline, 3, 6, and 12 months in order to characterize the immunological changes in patients.
DBV Technologies
Forward Looking Statements
DBV Investor Relations Contact
DBV Media Contact
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: DBV Technologies via GlobeNewswire
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