Shares in DBV Technologies (EPA:DBV) traded up as much as 13% in Paris following the publication of long-term data from a trial of its peanut allergy treatment. The open-label extension to a Phase IIb trial found that the extra year of taking Viaskin Peanut was associated with a rise in the proportion of kids who responded to the treatment.
|DBV CEO Dr. Pierre-Henri Benhamou|
Paris, France-based DBV enrolled 21 children from the treatment arm of the Phase IIb trial, each of whom was aged between 6 and 11 years old at the start of the original study, in the open-label follow-up. Over the extra 12 months of treatment with Viaskin Peanut 250µg, the proportion of the kids who experienced a 10-fold uptick in tolerance or could consume 1,000 mg of peanut protein increased by 23 percentage points to 80%. The period was also characterized by a jump in the mean cumulative reactive dose of peanut protein, which trended up 76% to hit 1,884 mg.
The improvement over time has encouraged DBV to start speculating about what might happen as treatment continues into a third year. "We already know that we have a product that can protect patients after one year and that is absolutely safe," DBV Chief Operating Officer David Schilansky told Bloomberg. "Now we're showing efficacy increases after two years, and after three years, we could see a lasting effect." DBV has already tracked one teenage participant in the Phase IIb study who is still tolerant to peanuts one year after stopping treatment.
Half of the kids who transferred to the follow-on study from the placebo arm of the Phase IIb trial were classed as responders after their first 12 months of treatment, a result that is consistent with data from the earlier component of the program. The data, particularly where it suggests a sustained effect, could help DBV if it reaches a point at which it is scrapping for market share with rival peanut allergy drug developer Aimmune Therapeutics. Both companies are still some way from approval, though.
The next step for DBV is a 260-person Phase III trial, which is due to get underway before the end of the year. With the Phase IIb data raising expectations among physicians and investors--shares in DBV are up more than 50% this year--the trials will be closely watched. "If [the results are] confirmed in DBV's Phase III trial, Viaskin could be a breakthrough therapy for young children with peanut allergy," James Baker, CEO of the Food Allergy Research & Education patient organization, said in a statement.
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