DBV Technologies has posted phase 3 data suggesting safety and compliance are unlikely to scuttle its hopes of winning approval of peanut allergy treatment Viaskin Peanut. Shares in DBV rose on the back of the data, going a little way toward erasing the big drop it suffered after missing its primary efficacy endpoint.
Paris-based DBV was poleaxed by efficacy data from another phase 3 trial last month but, at the time and in the following weeks, it has remained steadfast in its belief that Viaskin Peanut can win approval on the strength of the results. More analysts have come around to DBV’s way of thinking as they have digested the specifics of the results in recent weeks.
DBV’s market cap is still down close to 50% on the levels it hit before the phase 3 miss. But today’s double-digit rise suggests investors may be joining DBV in holding out hope the FDA will look kindly on an application for approval of Viaskin Peanut.
The rise followed the publication of safety data from the phase 3 REALISE trial. DBV reported three serious adverse events in three patients across the near-400 patient study. Only one of the events involved a patient in the Viaskin Peanut arm. That event was a case of moderate anaphylaxis, thought to be related to the treatment, which responded to standard outpatient therapy.
Other adverse events, notably local application site reactions, were more common but only of mild to moderate severity, a fact reflected in the dropout and compliance rates. Across the six-month blinded period of the trial, DBV saw 2.5% of patients drop out. The dropout rate attributed to adverse events was 1%. Mean patient compliance topped 95%.
These are the type of data points that could help DBV carve out a piece of the market if Viaskin Peanut ends up duking it out in the commercial ring with a rival drug from Aimmune Therapeutics.
Whether that happens depends on how the FDA responds to DBV’s argument that Viaskin Peanut should come to market despite failing to clear the regulator’s efficacy bar. Viaskin Peanut fell short against that yardstick despite statistically outperforming placebo.
“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., in a statement.
Jefferies’ analysts say they expect the biotech to file a BLA in the first half of 2018 and continue to see around a “50/50 likelihood for FDA approval.”