Aimmune Therapeutics Announces New Clinical Data on AR101 for Peanut Allergy at the 2018 EAACI Congress
- New analyses including adults enrolled in the Phase 3 PALISADE trial of AR101 show efficacy across the entire intent-to-treat population of peanut-allergic patients ages 4-55
- New immunologic subset analyses show that AR101 treatment was linked to depletion of peanut-specific TH2A cells believed to drive the allergic response
PALISADE enrolled a total of 554 patients ages 4-55 (90% ages 4-17). After approximately one year of treatment (up-dosing and maintenance), clinical reactivity to peanut protein was assessed in an exit double-blind, placebo-controlled food challenge (DBPCFC). The trial met its primary endpoint as 67% of AR101 patients ages 4–17 tolerated at least a 600-mg dose of peanut protein in the exit DBPCFC, compared to 4% of placebo patients (p<0.00001). The lower-bound of the 95% confidence interval (CI) of the difference between treatment arms at the primary endpoint was 53%, greatly exceeding the pre-specified threshold of 15% (p<0.00001).
Based on these results, Aimmune plans to submit a Biologics License
Application (BLA) for AR101 to the
Efficacy Across All Age Groups
New analyses presented at EAACI of the 4-55 age intent-to-treat population showed a statistically significant difference of 60% between the proportion of patients in the AR101 group (65%) and placebo group (5%) who tolerated the 600-mg dose of peanut protein in the exit DBPCFC (p<0.00001; 95% CI: 50, 69). In an exploratory analysis of AR101 patients who completed the trial, efficacy was similar across all ages, refined into three groups. In the exit DBPCFC, 85% of children (ages 4-11), 83% of adolescents (ages 12-17), and 85% of adults (ages 18-55) tolerated the 600-mg dose of peanut protein. Though the number of adults in the study was small, the treatment difference in this population showed a strong trend on an intent-to-treat basis (p=0.07). The safety profile in adults was similar to that observed in the pediatric and adolescent populations previously reported.
“There is a significant need for approved treatments for peanut allergy
as it can be profoundly disruptive to the lives of families caring for
affected loved-ones and costly to them and the healthcare system,” said
Prof. George du Toit, M.B., B.Ch., of King’s College London, Guy’s and
Biomarkers Show Immunologic Changes Associated with AR101
In a separate late-breaking presentation, Prof.
New data from the laboratory of Dr.
“We are deeply grateful to the PALISADE patients, families, and
investigators for their contributions to this landmark study in peanut
allergy, which brings us a big step closer to delivering on our
commitment to the food allergy community of winning approval for our
characterized, biologic oral immunotherapy medicines,” said
PALISADE (Peanut ALlergy oral Immunotherapy Study of AR101 for DEsensitization in children and adults) was an international, randomized 3:1, double-blind, placebo-controlled, Phase 3 trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach in patients with peanut allergy.
AR101 is a novel, investigational oral biologic drug for use in oral immunotherapy (OIT) in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), has a characterized protein profile found in peanuts, analyzed to ensure consistent major allergen content. The amount of active ingredient in each AR101 capsule is controlled to ensure minimal variability of allergen content across doses of a given strength.
- du Toit, G. et al. Efficacy and Safety of AR101 in Peanut Allergic Patients Aged 4–55: Results from an International Phase 3, Randomised, Double-Blind, Placebo-Controlled Trial (PALISADE). EAACI 2018 (Abstract #1874).
- Deschildres, A. et al. Peanut-allergic patients in the MIRABEL survey: characteristics, allergists’ dietary advice and lessons from real life. Clinical & Experimental Allergy 2016; 46:610-620.
- Beyer, K. et al. Immune Responses in 496 Patients Aged 4–17 Years with Peanut Allergy Treated with Oral Immunotherapy Using AR101: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial (PALISADE). EAACI 2018 (Abstract #1672).
Wambre, E. et al. A phenotypically and functionally distinct
human TH2 cell subpopulation is associated with allergic disorders. Sci
Transl Med 2017;
Aug 2;9(401). pii: eaam9171.
Statements contained in this press release regarding matters that are
not historical facts are “forward-looking statements” within the meaning
of the Private Securities Litigation Reform Act of 1995. Because such
statements are subject to risks and uncertainties, actual results may
differ materially from those expressed or implied by such
forward-looking statements. Such statements include, but are not limited
to, statements regarding: Aimmune’s expectations regarding the potential
benefits of AR101; Aimmune’s expectations regarding potential
applications of the CODIT™ approach to treating life-threatening food
allergies; Aimmune’s expectations regarding the approvability of AR101;
and Aimmune’s expectations regarding the timing of potential regulatory
filings for marketing approval of AR101 in
This press release concerns a product that is under clinical
investigation and that has not yet been approved for marketing by the