A couple of years ago, Paris-based DBV Technologies $DBVT set aside $95 million from an offering for its Phase III trial of a new therapy for peanut allergies.
On Friday, after the US market closed, DBV announced that the Phase III flopped, with their treatment unable to mark a statistically significant separation from a placebo arm as defined by the trial protocol. But the French biotech adds that they aren’t letting a primary endpoint failure stop them from filing a new drug application with the FDA in any case.
The placebo response in the study — 13.6% — came in just a tiny bit higher than the 12% response rate seen in a mid-stage control arm. But the positive response to their Viaskin Peanut 250 μg dose — designed to push reactive immune systems to tolerating peanut protein — tailed off considerably, dropping from 48% in Phase II to only 35.3% in the late-stage trial after 12 months of therapy.
Further complicating DBV’s quest, Aimmune Therapeutics is expected to roll out late-stage data for their rival allergy remedy AR101 in the next few months. And just a few days ago the biotech lined up a combination study matching their therapy with dupilumab, from Regeneron and Sanofi.
Credit Suisse, for one, was still betting on Aimmune a few days ago, noting: “We remain bullish on Aimmune ahead of PALISADE and continue to like the setup for Aimmune ahead of data from key competitor DBV…”
In the wake of the announcement, DBV’s shares were crushed, losing 52% of their value. Aimmune shares $AIMT immediately soared 45%.
Eun Yang at Jefferies, though, still thinks the DBV drug has a better than 50/50 shot at an approval, given:
(1) stat. sig. Ph3 data; (2) likely clinically meaningful tx effect for preventing accidental exposure based on a key 2ndary endpoint of cumulative reactive dose (CRD) of 900mg (~3 peanuts) on VP vs. 360mg on placebo (~one peanut; p<0.001; vs. baseline 210mg); (3) potentially improved tx response over time (24mo vs. 12mo), which FDA may want to see prior to approval (24mo data, if measured, around the time of approval if BLA filed in 1H18); & (4) clean safety (1.1% dropout due to tx out of 10.1% total & >95% compliance).
DBV CSO and Mount Sinai professor Hugh Sampson suggested that the biotech plans to sell the cumulative impact from all the data to regulators, along with a “clinically meaningful” impact for patients who currently don’t have a drug approved for peanut allergies. He said:
The findings in this study underscore the potential of epicutaneous immunotherapy, and we continue to be encouraged by the response rate and clinically meaningful improvements in cumulative reactive dose that we observed. We believe the strength of all clinical data we have seen to date in over 650 patients supports the safety and efficacy profile of Viaskin Peanut, and look forward to seeing the full results from this trial.
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