Aimmune Therapeutics presented new data on its AR101 peanut allergy therapy as well as a real-world data study at the American College of Asthma, Allergy and Immunology (ACAAI) Annual Scientific Meeting in Houston.
AR101 is an investigational, peanut-derived, biologic drug candidate for oral immunotherapy in patients with peanut allergy. It delivers a daily dose of peanut protein with a consistent protein profile.
The company presented results from a new analysis of the drug in the Phase III PALISADE and ARTEMIS trials. Both met the primary efficacy endpoints. PALISADE was conducted at 66 sites in 10 countries in North America and Europe on 496 patients ages 4 to 17. They were randomized 3:1 to receive AR101 or a placebo along with 55 adults ages 18 to 49 who were not part of the primary analysis. They received a dose escalation of about 22 weeks until they reached a therapeutic dose of 300 mg per day of AR101 or placebo, then continued with that daily dose or placebo for about six months. They were then tested on various doses of peanut protein to evaluate if they had developed a tolerance to peanut allergen.
ARTEMIS was conducted in 18 sites in seven European countries on 175 children and adolescents ages 4 to 17. They were also randomized 3:1 for the drug or placebo with six months of dose escalation and then three months of therapeutic dosing at 300 mg/day or placebo, followed by a test.
“I’m encouraged to see that, across two robust and rigorously conducted clinical trials, the efficacy and safety of AR101 was consistent showing that treatment resulted in patients tolerating higher quantities of peanut protein while also confirming that the frequency of adverse events—while mostly mild or moderate—decreased during the therapeutic dosing period across both studies,” said Ellen R. Sher, study author and an allergist and immunologist with Allergy Partners of New Jersey, Section Chief of Allergy and Immunology at Monmouth Medical Center, and a clinical assistant professor of medicine at Rutgers Robert Wood Johnson Medical School.
Sher added, “As an allergist, I understand the importance of carefully discussing with patients and parents whether OIT is right for them and that it can be tailored to their needs. The similarities between the PALISADE and ARTEMIS trials provide important insights regarding the clinical potential of AR101 in treating a variety of patients, regardless of geographic location and other factors we take into consideration.”
The company also presented a study showing that the logistical needs for implementing OIT for food allergies, such as the AR101, into clinical practice is similar to subcutaneous immunotherapy (SCIT) for environmental allergies. The company ran a double-blinded, self-administered online survey of 80 allergists and immunologists who use both OIT and SCIT in clinical practice. The results suggested that the logistics of staff to providers and number of exam rooms, was the same for either approach.
“As more and more allergists consider incorporating OIT into their clinical practice as a potential treatment approach for people with food allergies, it’s important that the implementation can be seamless from a logistical perspective and enable allergists to continue to deliver personalized care, similar to what they’re familiar with when performing environmental allergy shots which are already part of their established practice,” said Joel M. Hartman, study author and physician owner at Allergy Partners. “We believe allergists and immunologists who are considering adding OIT to their practices for food allergy will be pleased to hear the results from the survey, as it proves to be a similar implementation process to the age-old and widely accepted approach currently used for allergies such as mold, dust, grass/weeds and animal dander.”