Days after the FDA finally accepted the application to review its peanut allergy immunotherapy, Aimmune laid out positive pivotal study data from its European Phase III study on Monday, paving the way for an EMA marketing application by mid-2019.
The drug developer, which has essentially leapfrogged its arch rival DBV Technologies $DBVT in the United States, said its drug — AR101 — helped shore up tolerance in peanut-allergic subjects in a 175-patient trial called ARTEMIS. Patients underwent approximately six months of dose escalation and then three months at a daily therapeutic dose of AR101 at 300 mg or placebo, followed by a placebo-controlled food challenge.
AR101 met the main goal of significantly improving patients’ ability to tolerate a 1,000-mg single dose of peanut protein (p<0.00001) — which correlates to at least three or four peanuts — versus those who got the placebo. Overall, the median tolerated dose of peanut protein for AR101-treated patients improved 100-fold, from 10 mg at baseline to 1,000 mg at exit, the company said.
“This level of protection provides ample buffer beyond a typical bite of a peanut-containing food in the real world,” said Aimmune chief Jayson Dallas in a statement. “AR101 has the potential to become the first approved therapy for peanut allergy in both the United States and Europe, where up to two percent of children in many countries are affected.”
The ARTEMIS findings echo the results from the highest level tested in Aimmune’s landmark Phase III PALISADE trial, which formed an integral portion of Aimmune’s US application. PALISADE data showed 50.3% of AR101-treated patients tolerated a single highest dose of 1,000 mg of peanut protein after approximately six months of dose escalation followed by six months at a daily therapeutic dose of 300 mg, compared to 2.4% of placebo patients (p<0.00001).
“The ARTEMIS data demonstrate that most patients exceeded what we consider to be protective levels well before a full year of treatment…these data build upon the insights gained throughout the entire AR101 program regarding the desensitization process and the ability of our patients to tolerate relatively large challenge-doses of peanut protein,” Aimmune’s CMO Daniel Adelman said.
The FDA is expected to make a decision on AR101 by January 2020, California-based Aimmune said last week.
DBV $DBVT rescinded an application to market its peanut allergy patch on December 20 in response to FDA concerns about the state of manufacturing and quality control data submitted, and the following day, Aimmune $AIMT submitted its application for AR101, in effect leapfrogging its competition for a first-mover shot at capturing the so far untapped market, which is expected to grow to $4.5 billion in 2027 globally, according to GlobalData. The US shutdown began on December 22. By mid-January, Aimmune said the health regulator had notified them that it would not be able to review the application until the lapse in appropriations ended. Ten days later, on January 25th, the government reopened, and the AR101 application was back in contention.
Aimmune’s investigational egg allergy product — AR201 — is expected to be evaluated in a Phase II study mid-2019. The condition affects an estimated 6 million people in the US, Europe, Japan and China.
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