New Data from Phase 3 PALISADE Follow-on Study of AR101 for Peanut Allergy Show Continued Immunomodulation Through Daily Dosing Beyond One Year
--Patients tolerated as much as 2,000 mg of peanut protein with fewer adverse events --
--Favorable ongoing and notable immunological changes observed over time--
After continuing daily doses of AR101 for an additional 28 weeks, the majority of patients enrolled in the follow-on study could tolerate doses of at least 1,000 mg of peanut protein, and nearly half of all AR101-treated patients tolerated the highest 2,000 mg dose during the exit food challenge. Furthermore, patients enrolled in the study continued to see meaningful immunological changes, reinforcing the potential benefits of continued daily AR101 dosing after one year.
“The results of this follow-on study to the PALISADE trial demonstrate
that AR101 can produce favourable immunological changes over time,
matched by patients’ ability to tolerate higher doses of peanut protein,
thus reinforcing the rationale for continued daily dosing of AR101
beyond one year,” said Katharina Blümchen, M.D., Associated Professor
and consultant for Paediatric Pneumology and Allergology at the
Of the AR101-treated patients in PALISADE who entered the open-label extension study, which evaluated safety, tolerability and immunological changes of continued daily or non-daily dosing with 300 mg of AR101, 110 were assigned to the daily dosing regimen, and 104 completed the double-blind, placebo-controlled food challenge (DBPCFC) after 28 weeks. Immunologic changes to peanut protein were compared at the end of the PALISADE trial and the end of the extended dosing period using a peanut skin prick test (SPT) and measurements of peanut-specific immunoglobulin E (psIgE) and immunoglobulin G4 (Ig4), each a marker of immunologic changes occurring during the desensitization process. After 28 weeks of extended maintenance with AR101, results showed:
Ability to Tolerate Peanut Protein
- 79.8% could tolerate a 1,000 mg challenge dose.
- 49% could tolerate the highest challenge dose of 2,000 mg.
- A reduction in adverse events overall with the same participants experiencing the same types of adverse events as during the PALISADE therapeutic dosing period and reporting at least one adverse event (PALISADE 88.2% vs. ARC004 84.5%).
- The severity of adverse events (AEs) was similar across the two studies, with the majority of symptoms reported to be mild in nature (PALISADE 54.5% vs. ARC004 52.7%).
- Only 2% of patients enrolled discontinued treatment during the extended maintenance period due to AEs.
Immune System Changes to Peanut Protein
- Favorable immunological changes for the population of patients studied continued during the additional daily dosing period, as confirmed by reductions in the SPT wheal diameter and levels of psIgE and a corresponding increase in IgG4; all reflecting a continued maturation of the desensitization and immunomodulatory processes in response to AR101.
- For an individual patient, the ability to tolerate more peanut protein appeared to occur independently of the observed ongoing immunomodulation associated with continued AR101 treatment.
- Study findings are consistent with reports that for an individual patient psIgE and SPT levels are not necessarily predictive of a patient’s ability to tolerate discrete amounts of peanut.
“These findings demonstrate that AR101 treatment extended into the
second year reduces adverse events, increases ability the ability to
tolerate even high levels of exposure to peanut protein over time, and
further modulates the immune response to peanut in most patients,” said
About PALISADE and the ARC004 Follow-on Study
The international, randomized, double-blind, placebo-controlled Phase 3
PALISADE (Peanut Allergy oral Immunotherapy Study
of AR101 for Desensitization) trial evaluated the efficacy
and safety of AR101 in patients with peanut allergy. PALISADE was
conducted at 66 sites in 10 countries in
A subset of patients who completed the Phase 3 PALISADE trial were eligible to enter ARC004, which evaluated safety, tolerability and immunological changes of continued daily or non-daily dosing with 300 mg of AR101. Immunologic changes to peanut protein were compared at the end of the PALISADE trial and the end of the extended therapeutic period using a peanut skin prick test and measurements of peanut-specific immunoglobulin E (psIgE) and immunoglobulin G4 (Ig4).
Full results from the PALISADE trial were published in the
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, including the potential benefit of continued therapy;
Aimmune’s expectations regarding the review of the BLA for AR101 by the
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 FDA or the European Medicines Agency (EMA). AR101 and AR201 are currently limited to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated.
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