Aimmune Therapeutics Enrolls First Patient in Phase 3 PALISADE Trial of AR101 for the Treatment of Peanut Allergy
— Aimmune Provides Year-End Update and Upcoming Milestones Review —
“With the opening of our Phase 3 PALISADE trial last month and now our
first patient enrolled, we have made a significant step forward in
delivering on high expectations to design and execute the largest
clinical trial ever conducted in food allergy,” said Aimmune CEO
PALISADE (PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY
OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS) is an
international, randomized 3:1, double-blind, placebo-controlled, Phase 3
trial of the efficacy and safety of AR101 in a characterized
desensitization (CODIT™) approach in patients with peanut allergy.
Aimmune expects PALISADE to enroll approximately 500 peanut-allergic
patients 4-55 years of age at more than 60 clinical sites in
“As we brought sites on for PALISADE, we heard widespread enthusiasm
from allergists for the potential of an approved treatment to protect
peanut-allergic patients of all ages from the effects of accidental
exposure to peanuts,” said Aimmune Chief Medical Officer
PALISADE will evaluate the safety and efficacy of AR101 for desensitizing peanut-allergic patients to a level sufficient to reliably protect them from allergic reactions upon accidental exposures to peanut. Under the PALISADE protocol, patients will undergo a dose escalation period of approximately 22 weeks to reach the maintenance dose of 300 mg per day, then continue with daily maintenance at 300 mg per day for approximately six months. At the end of the maintenance period, patients will undergo an exit double-blind, placebo-controlled food challenge (DBPCFC).
PALISADE’s primary endpoint is toleration of a cumulative amount of 1,043 mg of peanut protein in the exit DBPCFC. PALISADE’s inclusion criteria allow for baseline toleration of a cumulative amount not exceeding 44 mg of peanut protein in an entry DBPCFC. In Aimmune’s ARC001 Phase 2 study of AR101, where the inclusion criteria allowed toleration of a cumulative amount of up to 44 mg of peanut protein, 78 percent of active-arm patients who completed the study’s 22-week up-dosing protocol (n=23) tolerated a cumulative amount of 1,043 mg of peanut protein in the exit DBPCFC. Furthermore, in that study, 100 percent of active-arm patients who completed the study tolerated a cumulative amount of 443 mg of peanut protein, a level that is a secondary endpoint for PALISADE. As a typical peanut kernel contains approximately 250-300 mg of peanut protein, Aimmune believes PALISADE patients who receive treatment with AR101 and continue with maintenance dosing will be reliably protected to clinically meaningful levels of accidental peanut exposure.
Year-End Update and Upcoming Milestones Review
Aimmune also provided a 2015 year-end update and a review of upcoming milestones.
The company announced that it has:
Sue Barrowcliffeas General Manager of Europeand an executive officer of the company, effective January 2016. Ms. Barrowcliffe has been serving as Aimmune’s Senior Vice President, Regulatory, and Head of Europe. In her new role, Ms. Barrowcliffe will oversee all European operations, including product development efforts and preparations for a potential commercial launch of AR101 in Europe.
William Turneras Senior Vice President, Regulatory Affairs and Quality. Mr. Turner will have global responsibility for regulatory matters. He brings 20 years of regulatory experience to the company, including senior positions at Dynavaxand Medimmune.
- Been awarded a patent covering certain manufacturing methods for AR101 by the U.S. Patent and Trademark office.
The company anticipates achieving the following milestones in 2016 and 2017:
- Advance PALISADE Phase 3 trial of AR101
- Complete enrollment of PALISADE in second half of 2016
- Complete up-dosing of patients in first half of 2017
- Complete trial in second half of 2017
- Build upon CODIT™ platform
- File IND for second CODIT™ product, for egg allergy, in 2H 2016
- File IND for next program in 2017
- Address additional opportunities for utilization of AR101
- Evaluate AR101 in broader patient populations, including children ages 1 to 3
- Evaluate AR101 in additional clinical contexts
Aimmune ended 2015 in a strong financial position with approximately
About AR101 and CODIT™
AR101 is part of Aimmune’s approach to treating food allergies using its characterized oral desensitization immunotherapy, or CODIT™, system. The CODIT system leverages extensive independent scientific research on oral immunotherapy, or OIT, demonstrating that food allergy patients can be desensitized to food allergens by being administered well-defined, gradually increasing doses of the allergen over a period of months. Aimmune’s CODIT system is designed to precisely control the amounts of the allergens administered in a systematic dosing regimen, beginning with very low doses of the allergens. Once a patient attains a clinically meaningful level of desensitization, the patient continues to take a daily maintenance dose of the CODIT system product in order to maintain the desensitization.
About Food Allergies
Food allergies are a significant and growing health problem in
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: the sufficiency of Aimmune’s existing cash,
cash equivalents and investments to support Aimmune’s planned operations
through data read-out from the PALISADE trial; Aimmune’s development
efforts, including the size and timing of the planned Phase 3 PALISADE
trial; Aimmune’s expectations regarding the potential benefits of AR101;
Aimmune’s commercialization plans; and Aimmune’s expectations regarding
potential applications of its CODIT™ system. Risks and uncertainties
that contribute to the uncertain nature of the forward-looking
statements include: the expectation that Aimmune will need additional
funds to finance its operations, the potential for unanticipated capital
needs; the company’s ability to initiate and/or complete clinical
trials; the unpredictability of the regulatory process; the possibility
that Aimmune’s clinical trials will not be successful; the company’s
reliance on third parties for the manufacture of the company’s product
candidates; possible regulatory developments in
This press release concerns a product that is under clinical
investigation and that has not yet been approved for marketing by the