The Anaphylaxis Campaign is delighted to hear about the success of Aimmune Therapeutics, Inc. Phase 3 PALISADE trial and publication of its results in the New England Journal of Medicine.
PALISADE (Peanut Allergy oral Immunotherapy Study of AR101 for Desensitization, is an international, randomized (3:1), double-blind, placebo-controlled, phase 3 trial evaluating the efficacy and safety of AR101 in patients with peanut allergy. PALISADE was conducted at 66 sites in 10 countries in North America and Europe, where 496 patients ages 4–17 received either AR101 or placebo (372 AR101, 124 placebo), along with 55 adults ages 18–49, who were not part of the primary analysis.
AR101 is an oral drug that delivers peanut protein. Through a desensitisation approach, increasing doses of peanut protein were given over a 6-month period in an initial dose escalation phase, reaching a dose of 300mg. A maintenance phase proceeded this, lasting for 24 weeks with patients continually receiving this 300mg dose of peanut protein.
In the trial’s primary analysis of peanut-allergic children and adolescents ages 4–17, AR101 treatment resulted in a significant increase in the amount of peanut protein tolerated, compared to placebo. The increase, which was measured through a series of doses in an exit food challenge, suggests that AR101-treated patients could expect to have protection against reactions to accidental peanut exposures.
“Trials like PALISADE are crucial to the help build confidence for people living in fear of a severe reaction to allergies. Small successful steps will help towards a brighter future, not only for people with peanut allergies but hopefully for all allergies” say Anaphylaxis Campaign Chief Executive Lynne Regent.
To read, NEJM publication of PALISIDE results click on the following link: https://www.nejm.org/doi/full/10.1056/NEJMoa1812856
The link below is to Aimmune’s full statement:
Click on the following link to read about other treatments that Aimmune Therapeutics, Inc. are developing to help protect people with food allergies: https://www.aimmune.com/pipeline/
Links to the tree Leo’s Chapters
Chapter 3: Watch the animation on YouTube here.
Chapter 2: Watch the animation on YouTube here.
Chapter 1: Watch the film on YouTube here.
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