Aimmune Therapeutics Presents New AR101 Data at AAAAI, Including Demonstrated Reduction in Accidental Exposures to Peanut Requiring Treatment
— AR101 Associated with 70% Reduction in Allergic Reactions Due to Accidental Exposures That Required Treatment Compared to Placebo After Dose Escalation in PALISADE —
— AR101-Treated Patients Who Completed PALISADE Had 95% Increased Probability of Tolerating Any Dose of Peanut Protein in Exit Challenge Compared to Placebo —
— Tolerated Dose Increased for Two Thirds of AR101-Treated Patients in Challenge in PALISADE Follow-on Trial —
Key presentations demonstrated that AR101 treatment reduced accidental exposures to peanut requiring medication and, for participants who completed the exit food challenge at approximately 12 months, increased the probability of tolerating any dose of peanut protein by 95%. In addition, data from the open-label follow-on trial to PALISADE, ARC004, showed that two thirds of the patients treated for an additional six months with daily AR101 tolerated increased amounts of peanut protein.
“The difficulty of relying on avoidance to manage food allergies was
underscored in PALISADE where, even in the focused environment of a
clinical trial with daily reminders to avoid peanuts, accidental
exposures still occurred,” said
“Getting longer-term AR101 data is really exciting, as it shows us the
pattern of patients progressing from a roughly 12-month period of
elevated peanut-specific IgE to a period of continued immunomodulation,
as evidenced by further reductions in specific IgE levels,” said
Summary of Key Abstracts
- Data from PALISADE, a pivotal phase 3 trial that included 496 patients ages 4–17 (372 AR101-treated patients and 124 placebo patients), showed that fewer AR101-treated patients reported accidental exposures to peanuts requiring treatment (6.5%) compared to placebo patients (10.5%).
- During the second six months of PALISADE, there was a 70% reduction in the percentage of AR101-treated patients who required treatment for peanut-related accidental exposures compared to placebo patients (1.6% vs. 5.1%).
- No AR101-treated patients required epinephrine for accidental peanut exposure, compared to 2.4% of placebo patients.
- In addition, AR101-treated patients reported fewer accidental exposures to non-peanut food allergens compared to placebo patients over the full length of PALISADE (13.4% vs. 22.6%) and an even greater reduction during the second six months of treatment (7.4% vs. 15.3%).
- Consistent with results previously reported for the 12-month exit food challenge in PALISADE, an additional analysis showed that AR101-treated patients who completed the exit food challenge had a 95% increased probability of tolerating any peanut protein challenge dose compared to placebo patients.
- Longer-term data from study ARC004, an open-label follow-on trial to PALISADE, showed that nearly two thirds of the AR101-treated patients taking a daily 300-mg therapeutic dose who tolerated less than the highest dose at the PALISADE exit challenge (1,000 mg single dose) were able to tolerate more peanut protein at another challenge 28 weeks later. In addition, half the AR101-treated patients taking a daily therapeutic dose were able to tolerate the highest single dose tested (2,000 mg), which was twice the highest dose level administered in PALISADE.
AR101 is a complex biologic drug under investigation for the treatment
of children and adolescents with peanut allergy.
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 on regulatory submissions for
marketing approval of AR101 for peanut allergy in
Neither AR101 nor AR201 has been approved for marketing by the
Laura Hansen, Ph.D.