Aimmune's PhIII peanut allergy study wows on the primary endpoint, setting up FDA pitch -- and shares slide
Four months after DBV Technologies stock was crushed by a shaky set of pivotal data for its peanut allergy drug, rival Aimmune Therapeutics $AIMT says its Phase III has come through with a promising set of results. And the win sets up an FDA application later this year for the pioneering drug, with a European pitch to follow soon after.
Of the 554 patients in the study, 67.2% of the group in the AR101 drug arm were able to tolerate at least a 600 mg dose of peanut protein, protecting them from a potentially deadly allergic reaction against a small exposure. In the placebo arm, only 4% of the 4- to 17-year-olds in the study could say the same.
The data were put on a sliding scale based on exposure, with 96.3% OK with a 300 mg dose of peanut protein (about one peanut) and 50.3% of AR101 patients tolerating the single highest dose of 1000 mg of peanut protein.
Aimmune shares initially shot up 21% in early trading, while DBV saw its stock $DBVT slide another 10%. But the rally didn’t last long. Aimmune’s shares were down 3% Tuesday afternoon.
“It’s great to have patients go from managing to tolerate at most the amount of peanut protein in a tenth of a peanut without reacting to successfully eating the equivalent of between two to four peanuts with nothing more than mild, transient symptoms, if any at all,” said principal investigator Wesley Burks, from the University of North Carolina School of Medicine.
There was a high drop out rate, though, with 20.4% of AR101 patients — versus 6.5% of placebo patients — discontinuing the trial, often as a result of an adverse event.
Compare those results to DBV, and you’ll see a wide gulf separating the two.
The placebo response in the DBV 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 get reactive immune systems to tolerate 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.
DBV nevertheless said it would push for an FDA OK in any case.