Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for AR101, an investigational biologic oral immunotherapy for the treatment of peanut allergy in children and adolescents ages 4–17. The FDA granted AR101 Fast Track Designation for peanut allergy in September 2014 and Breakthrough Therapy Designation for peanut allergy in ages 4–17 in June 2015.
“The submission of the BLA represents a significant milestone for Aimmune and the food allergy community, for whom there currently are no approved treatments,” said Jayson Dallas, M.D., President and CEO of Aimmune. “We have requested FDA Priority Review and look forward to working with the agency to bring what could be the first approved treatment in food allergy to patients as quickly as possible.”
Aimmune’s BLA submission includes data from the pivotal Phase 3 PALISADE trial of AR101, recently published in the New England Journal of Medicine; the PALISADE follow-on trial ARC004; and the Phase 3 RAMSES trial, which confirmed that the safety profile of AR101 was consistent with that observed in the PALISADE trial; as well as extensive data on AR101 chemistry, manufacturing and controls (CMC).
“Based on positive results from the PALISADE trial, we believe that AR101 offers the only path to potential protection that matters for kids and teens with peanut allergy,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. “We are indebted to all those who helped us reach this important point in our development, including our employees, clinical investigators, advocates, and, of course, our patients and their families.”
Under the Prescription Drug User Fee Act (PDUFA), a Priority Review would target a review time of six months, compared to a standard review time of 10 months. FDA informs the applicant of a Priority Review designation within 60 days of a BLA submission.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational biologic product using CODIT™, AR101 for the treatment of peanut allergy, has received the FDA’s Breakthrough Therapy Designation for the desensitization of peanut-allergic patients 4–17 years of age. Aimmune’s regulatory filing for marketing approval of AR101 in the United States (submitted 4Q18) and Europe (1H19) are based on data from the pivotal Phase 3 PALISADE clinical trial of AR101, which in 4–17-year-old subjects met its primary and key secondary endpoints, and additional ongoing and completed AR101 clinical trials. Aimmune has filed an IND application for its second product, AR201, for the treatment of egg allergy and intends to start a randomized Phase 2 clinical trial in the first half of 2019. For more information, please see www.aimmune.com.
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 potential commercial launch of AR101, including the timing of a potential approval of AR101; Aimmune’s expectations that the FDA will conduct a Priority Review of the BLA for AR101; Aimmune’s expectations on the timing of initiating a Phase 2 clinical trial for AR201; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in the United States and Europe, including the timing of the submission in Europe; and Aimmune’s expectations regarding potential applications of the CODIT™ approach to treating life-threatening food allergies. 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; Aimmune’s or any of its collaborative partners’ ability to initiate and/or complete clinical trials; the unpredictability of the regulatory process; the possibility that Aimmune’s or any of its collaborative partners’ clinical trials will not be successful; Aimmune’s dependence on the success of AR101; Aimmune’s reliance on third parties for the manufacture of Aimmune’s product candidates; possible regulatory developments in the United States and foreign countries; and Aimmune’s ability to attract and retain senior management personnel. These and other risks and uncertainties are described more fully in Aimmune’s most recent filings with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018. All forward-looking statements contained in this press release speak only as of the date on which they were made. Aimmune undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
This press release concerns AR101, a product that is under clinical investigation, and AR201, a product that Aimmune expects will be under clinical investigation in 2019. Neither AR101 nor AR201 has been approved for marketing by the U.S. Food and Drug Administration (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.
Laura Hansen, Ph.D.