Shares of Aimmune Therapeutics (AIMT - Free Report) fell 6.9% on Jul 11, following negative review in a report from the Institute for Clinical and Economic Review (“ICER”) on the company’s immunotherapy candidate, AR101, for peanut allergy. Per the report, the short-term risk related to treatment with AR101 outweighs the estimated long-term benefits of desensitization in patients.
The ICER is an independent research organization evaluating the clinical and economic value of prescription drugs and other healthcare related products. The organization evaluated two investigational peanut allergy candidates — Aimmune’s AR101 and France-based DBV Technologies’ Viaskin.
Currently, a biologics license application (“BLA”) for AR101 is under review as a treatment for desensitization of patients with peanut allergy. A decision from the FDA is expected in January 2020. A BLA for Viaskin was withdrawn by DBV Technologies in December 2018 but is expected to be re-filed soon.
In its report, the ICER states that clinical data were not enough to demonstrate superiority compared to strict peanut avoidance in net health benefit for both the candidates. The organization noted three concerns related to treatment with AR101 — indefinite treatment requirement with no long-term efficacy and safety evidence, expected increase in the risk of allergic reaction in short-term, and persisting fear of accidental exposure to peanuts even after desensitization.
Although the ICER is not related to the FDA, its report may have an impact on the latter’s decision that is expected next year. The FDA will hold an advisory committee meeting in September 2019 to discuss the BLA for AR101.
Meanwhile, shares of Aimmune have decreased 22.6% so far this year against the industry’s 2.8% growth.
Notably, the company has released a statement defending AR101 against the concerns raised by the ICER.
In its release, Aimmune stated the ICER’s review is biased against immunotherapies. It also added that the research organization failed to incorporate long-term data from its PALISADE open label follow-on study on AR101. The study evaluated the candidate for approximately 12 months, with an additional follow-up period of 28 weeks. Clinical data demonstrated that treatment with AR101 increased the median tolerated dose of peanut protein from 10mg at baseline to 2000 mg after 18 months.
Investors should remain focused on the outcome of the FDA meeting, which will likely provide a better picture for the path ahead for AR101. Please note that, Aimmune is also evaluating AR101 in combination with Sanofi’s (SNY - Free Report) dupilumab in a phase II study for treating peanut allergy.
Aimmune apart, other pharma/biotech companies developing treatments for food allergies include Roche (RHHBY - Free Report) /Novartis’ (NVS - Free Report) marketed drug, Xolair.
Aimmune currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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