US biotech Aimmune has a positive European phase 3 study for its peanut allergy therapy AR101 to match its US trial, setting up an EU filing in the next few months.
The oral immunotherapy met the primary objective in the phase 3 trial ARTEMIS trial in children and adolescents, outperforming placebo when it came to inducing tolerance to a single 1,000mg dose of peanut protein – equivalent to three to four peanut kernels.
Subjects in the study were given escalating doses of AR101 over six months to induce tolerance, followed by another three months at a therapeutic dose, and according to Aimmune CEO Jayson Dallas, the level of protection with the therapy “provides ample buffer beyond a typical bite of a peanut-containing food in the real world.”
CEO Jayson Dallas
No cases of serious effects such as anaphylaxis or of eosinophilic esophagitis (EoE) were observed during the study, further reinforcing AR101’s profile.
The new data comes after an earlier US study, called PALISADE, which found that 50.3% of AR101-treated patients tolerated a single highest dose of 1,000mg of peanut protein compared to 2.4% of placebo patients. That study formed the basis of a US regulatory filing at the end of last year, which is due for a verdict in early 2020.
Dallas says AR101 is now on course to become the first approved therapy for peanut allergy in both the US and Europe “where up to 2% of children in many countries are affected.”
He adds: “If approved, AR101 could significantly reduce their risk of severe, potentially life-threatening reactions to peanut exposures and provide peace of mind to them and their families.”
The regulatory timeframe outs Aimmune ahead of French biotech DBV Technologies – which is gearing up to refile its Viaskin Peanut candidate later this year in the US having had to withdraw its first attempt – as well other rivals including the UK’s Allergy Therapeutics whose candidate is still in early development.
AR101 is one of PMLive’s launches to watch in 2019, as it is looks set to be the first entrant in a market that analysts predict could be worth $4.8bn a year, given that there are around 1.5 million people with peanut allergy apiece in the US and Europe.
Analysts have also suggested that aside from the first-mover advantage, the efficacy data for AR101 is stronger than for Viaskin Peanut so Aimmune’s drug is expected to capture the lion’s share of the market.