DBV Technologies has announced that reporting its positive safety and compliance results in phase 3 data of peanut allergy treatment Viaskin Peanut will not hinder the biotech’s optimism of gaining market approval. DBV shares gained from the support of the data, but minimally touching the plunge it endured after missing its primary efficacy endpoint.
DBV’s market capitalization remains down 50% from the levels it reached before the phase 3 failure. The stock’s recent double-digit increase can indicate that Wall Street supports DBV in hopes that the Food and Drug Admiration will be kind in application for approval of Viaskin Peanut. The sharp increase came after the reporting of safety data from the phase 3 REALISE trial. DBV described three serious adverse occurrences in three patients, when the study encompassed nearly four hundred patients, and only one occurrence involved a patient and Viaskin Peanut. A case of moderate anaphylaxis was reported which is believed to be related to the treatment and responded to typical outpatient therapy.
Another adverse occurrence was the mild to moderate application site reactions reported which was exposed in the dropout and compliance rates. During the six-month blinded trial period, DBV had 2.5% of patients drop out, with 1% related to adverse occurrences. Mean patient compliance surpassed 95%. These statistics are certainly what DBV needs to make their way into the market against a competing drug from Aimmune Therapeutics.
This all depends on how the FDA will act in response to DBV’s line of reasoning that Viaskin Peanut should be able to go to market regardless of failing the efficacy bar. Viaskin Peanut fell short against that index, although it statistically surpassed the placebo. Analysts anticipate the company to file a Biologics License Application during the first six months of next year and continue to predict a “50/50 likelihood for FDA approval.”
“This trial, which was the first phase 3 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,” said DBV CEO Pierre-Henri Benhamou, M.D.