DBV patches up prospects with phase 3 win in infants with peanut allergies

DBV Technologies has chalked up a win for its beleaguered peanut allergy patch candidate, hitting the primary endpoint in a phase 3 clinical trial in infants to send its battered share price past its prior high for 2022.

The French biotech has suffered multiple setbacks in its bid to bring Viaskin Peanut to market, missing the primary goal of a phase 3 clinical trial in children aged 4 to 11 years in 2017 and then withdrawing its submission for approval the following year after the FDA found fault with its filing. When DBV refiled, the FDA raised questions about the impact of patch adhesion on efficacy, leading to a rejection and two rounds of restructuring. The study in infants offered DBV a chance to regain momentum. 

“We look at this as being a product with very, very strikingly positive data in a patient population, 1- to 3-year-olds, where there's no other product that's approved. That to us is a distinct regulatory set of arguments. We need to give this a lot more thought, as to what is the right way to approach agencies, if we choose to do so,” DBV CEO Daniel Tassé said on a conference call with investors to discuss the data.

Investigators enrolled 362 children aged 1 to 3 years. Two-thirds of participants received Viaskin Peanut 250 micrograms, with the rest assigned to the control group. At 12 months, 67% of participants in the treatment arm met the response criteria, compared to 33.5% of subjects in the control group. The lower bound of the 95% confidence interval of the difference between the two arms was 22.4%, exceeding the pre-specified threshold of 15% and causing the study to meet its primary endpoint.

The primary endpoint categorized a patient as a responder if they went from a baseline eliciting dose of 10 mg or less to an eliciting dose of 300 mg or more of peanut protein at Month 12, or if they went from a baseline dose of more than 10 mg to a dose of 1,000 mg or more at Month 12.

An additional pre-specified efficacy analysis looked at the proportion of people who had an eliciting dose of 1,000 mg or more at Month 12, regardless of their status at baseline. In the treatment arm, 64.2% of subjects met that definition of responder, compared to 29.6% of their counterparts on placebo. A natural history study released in 2015 found peanut allergy resolves spontaneously in 22% of children by the age of four years.

On the safety front, 8.6% of subjects in the treatment arm experienced a serious adverse event, versus 2.5% of the participants in the control group. Only one of the events, mild swelling around the eye, was deemed related to Viaskin Peanut. Four subjects in the treatment arm had an anaphylactic reaction that may have been related to Viaskin Peanut. One reaction resolved spontaneously while the others cleared up after a single dose of epinephrine.  

The phase 3 results provided a boost to DBV, sending its share price up around 17% to $1.80 premarket, at a time when it faces questions about the next steps for its attempt to bring the patch to market in older kids. A pivotal phase 3 trial is planned, but DBV will need additional funding to deliver the study.