Pivotal Phase 3 ARTEMIS Trial Data Demonstrates Consistent Safety and Efficacy of AR101 in Children and Adolescents with Peanut Allergy
The proportion of AR101-treated patients who tolerated the 1,000 mg (2,043 mg cumulative) dose of peanut protein in the double-blind, placebo-controlled food challenge (DBPCFC) was significantly higher than in the placebo group: 58% vs. 2% (p<0.00001). The AR101-treated patients had less severe symptoms during the exit peanut DBPCFC, compared with the placebo-treated patients.
“Results of the European ARTEMIS trial provide further clinical
validation of the safety and efficacy of AR101 for children and
adolescents with peanut allergy,” said Prof. Montserrat Fernández-Rivas,
M.D., Ph.D., ARTEMIS investigator and Chief of the
In the study, 175 subjects aged 4 to 17 years in seven European countries were randomized 3:1 to AR101 or placebo, up-dosed to 6 mg on day 1 and received dose escalations every two weeks for 20-40 weeks until the therapeutic dose of 300 mg was reached. This was followed by approximately three months of continued 300 mg/day therapeutic dosing. The primary endpoint was the ability to tolerate at least 1,000 mg of peanut protein as a single dose without dose-limiting symptoms at exit DBPCFC.
The full results from 175 patients who started the trial showed:
- 58.3% of AR101-treated patients successfully tolerated 1,000 mg of peanut protein at the exit food challenge, compared to 2.3% in placebo group (p<0.00001).
- 68.2% of AR101-treated patients successfully tolerated 600 mg at the exit food challenge, compared to 9.3% in the placebo group.
- 73.5% of AR101-treated patients successfully tolerated 300 mg of peanut protein at the exit food challenge, compared to 16.3% in the placebo group.
The safety profile of AR101 was consistent with previous AR101 studies with the frequency and severity of allergic reactions as expected for an oral desensitization therapy. Mild or moderate systemic allergic reactions were reported in 12.1% of AR101-treated subjects and 2.3% of placebo-treated subjects. Epinephrine/adrenaline use was reported in 6.8% of AR101 treated participants versus 2.3% of placebo, all for mild/moderate reactions and lower than reported in PALISADE. Discontinuations due to related adverse events affected 9.8% of AR101-treated subjects, with no serious adverse events reported that led to discontinuation, and no deaths or suspected unexpected serious adverse reactions (SUSARs). There were no reported cases of eosinophilic esophagitis (EoE) and no cases of severe anaphylaxis.
“The results from ARTEMIS are remarkably similar to what was observed
with the highest exit challenge dose level first tested in the Phase 3
PALISADE trial. In PALISADE, 50.3% of AR101-treated patients tolerated
the highest test dose of 1,000 mg of peanut protein after approximately
six months of dose escalation followed by six months at a daily
therapeutic dose of 300 mg compared to 2.4% of placebo patients,” said
Dr. Adelman continued, “With the ARTEMIS data now in hand, we remain on
track to submit a Marketing Authorization Application for AR101 to the
The randomized, double-blind, placebo-controlled Phase 3 ARTEMIS (AR101
Trial in Europe Measuring oral Immunotherapy Success)
trial evaluated the efficacy and safety of AR101 in peanut-allergic
patients ages 4 to 17 years who were enrolled at 18 sites in seven
European countries (
About Peanut Allergy
Peanut allergy is one of the most common food allergies, affecting more
than 6 million people in the U.S. and
AR101 is a new, peanut-derived investigational oral biologic drug for use in oral immunotherapy in patients with peanut allergy. The drug, which is manufactured in accordance with current Good Manufacturing Practices (cGMP), delivers a daily dose of peanut protein with a consistent protein profile, analyzed to ensure reliable 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. AR101 is administered as an oral powder in graduated doses in pull-apart capsules or foil-laminate sachets. The contents are mixed thoroughly with a few spoonfuls of age-appropriate, unheated food of the patient’s choice.
Aimmune’s Biologics License Application (BLA) for AR101 was accepted for
review by the
About Aimmune Therapeutics
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 the review of the
BLA for AR101; Aimmune’s expectations regarding the planned timing and
filing for marketing approval of AR101 in
This press release concerns AR101, a product candidate that is under
clinical investigation, and AR201, a product candidate that Aimmune
expects will be under clinical investigation in 2019. Neither AR101 nor
AR201 has been approved for marketing by the
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