On March 4, 2018, Aimmune Therapeutics (AIMT) – a biopharmaceutical company developing treatments for potentially life-threatening food allergies confirmed the superior news that brings hope to children and adults who are susceptible to peanut allergic reactions.
The results from the firm’s pivotal Phase 3 PALISADE trial of its product AR101 for the treatment of peanut allergy were presented at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress in Orlando confirmed the good news about positive results, which Aimmune had previously last month.
The primary analysis of the patients ages 4–17, in the PALISADE clinical trial, demonstrate that the trial met its primary and secondary endpoints, and AR101 demonstrated encouraging tolerability and safety profile over the course of approximately one year of treatment.
AR101 has U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation for peanut-allergic patients ages 4–17, and Aimmune plans to submit a Biologics License Application for AR101 by the end of 2018.
Dr. Jones, Professor and Chief of Pediatric Allergy and Immunology at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, who has been a principal investigator of the Consortium of Food Allergy Research (CoFAR), a program supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), since it was founded in 2005 said, “Physicians, patients, and their parents are eager for a treatment for peanut allergy, and this large-scale, multi-center study is a big step toward a potentially viable option. In PALISADE, we were delighted to see a relatively low-maintenance dose yield not only impressive gains in the amount of peanut protein tolerated but also a very manageable tolerability and safety profile. Families will be excited to see these results that provide hope for them for a possible future treatment They want the potential of protection, and even a lessening of symptoms, due to accidental exposures to peanut in the real world.”
Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. stated that the results of the Phase 3 PALISADE trial exceeded the firm’s expectations.
PALISADE enrolled a total of 554 patients ages 4-49. In the primary analysis of ages 4–17, 296 patients (79.6%) from the AR101 arm completed the trial, compared to 116 patients (93.5%) from the placebo arm.
Important to note that patients with lower peanut-specific IgE group had a higher response rate at the 1000-mg endpoint, fewer GI-related withdrawals, and no severe treatment-related adverse events.
There were no deaths or suspected, unexpected serious adverse reactions (SUSARs) in the trial, and the incidence of serious adverse events (SAEs) was low, as 1.1% of AR101 patients experienced SAEs that were possibly related to treatment.
One AR101 patient (0.2%) experienced a severe SAE of anaphylaxis and withdrew from the trial; this patient had high peanut-specific IgE (>100 kU/L) at the start of the trial. There were no cases of anaphylactic shock observed in the trial.
Around 85.5% of patients on AR101 patients (85.5%) did not experience any investigator-reported systemic hypersensitivity reactions (SHRs) during the trial. Among the (14.5%) who did, nearly all (98.2%) had mild or moderate reactions.
To learn more about PALISADE and other more data from the trial read the firm’s press release.
The above news is definitely exciting news for people who are susceptible to peanut allergy. Millions of the susceptible people will be thrilled being able to eat peanut and not be afraid that food which might be contaminated with peanut would threaten their lives.
What about Aimmune’s pipeline?
In addition to the peanut allergy program, Aimmune is planning to initiate a second development program, targeting egg allergy, and a third program targeting walnut allergy.
The stock: Since the news about the success of the firm’s peanut program, the stock staged a rally from around $21 in mid-2017 to $36.05, which is today’s premarket trading stock price today, The market cap is around $1.943B.
It is important to remind that the product is not yet approved and that Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018, followed by a Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in the first half of 2019.
In the United States, AR101 has FDA Fast Track Designation, as well as FDA Breakthrough Therapy Designation for peanut-allergic patients ages 4–17.
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