DBV peanut allergy patch fails trial, but analysts say don’t write it off yet

DBV Technologies’ peanut allergy patch missed the mark—by a whisker—in a phase 3 trial but is still at least 50:50 for FDA approval, say analysts at Jefferies.

Top-line data from the PEPITES study showed that the Viaskin Peanut patch-based therapy showed a statistically significant improvement over placebo, but the difference wasn’t quite enough to meet the level of efficacy intended to support FDA approval, said the French biotech.

A 250 microgram daily dose of the immunotherapy resulted in 35.3% of children aged four to 11 developing a predefined level of tolerance to peanut allergens after 12 months, compared to 13.6% of those given a placebo patch, which Jefferies described as a “small” treatment effect size.

The data caused DBV’s Nasdaq-listed shares to slump almost 45% in after-hours trading, while oral peanut allergy vaccine developer Aimmune Therapeutics—fresh from announcing a new collaborative program with Regeneron/Sanofi—shot up around 47%.

Aimmune reported positive data for its AR101 candidate last spring, and DBV is now looking ahead to a second trial of Viaskin Peanut, called REALISE, that is due to report top-line data in November.

There is still no FDA-approved treatment for peanut allergy, which causes thousands of people to be admitted to the emergency room each year in the U.S. with anaphylactic reactions and—by some estimates—accounts for upwards of 50% of the 100-200 annual fatalities caused by allergies. Rising rates of peanut allergies has made the need for an effective treatment acute.

Jefferies said in a research note that the phase 3 miss—which came down to just two patients not hitting the mark in the 356-patent trial—came in the face of a fairly stringent efficacy threshold in the trial. The biotech “sees room for negotiation/flexibility on this criteria and a path forward from initial FDA discussion,” Jeffries said.

The two patients meant that Viaskin Peanut failed to meet the lower end of the 95% confidence interval for efficacy, but Jefferies points out that this was also the case with two other allergy drugs—Merck’s Odactra for house dust mite allergies and pollen allergy treatment Oralair from Stallergenes—that were ultimately approved by the FDA.

The analysts suggested that Viaskin Peanut’s commercial potential could hinge on its efficacy at 24 months as well as the outcome of Aimmune’s phase 3 trial of AR101, due to report early next year.

“We believe that this preliminary analysis shows significant therapeutic promise in the peanut-allergic population, where there is a high unmet medical need and no approved treatments,” said Pierre-Henri Benhamou, DBV’s CEO.

“Viaskin Peanut has been granted both breakthrough therapy and fast track designations by the FDA [and] we are committed to working together with the regulatory agencies to bring forward a safe and effective treatment option for these patients.”