Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing treatments for potentially life-threatening food allergies, today announced that it has initiated POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization), an international, Phase 3 clinical trial of AR101 in peanut-allergic children ages 1–3 years. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
“Following the success of our landmark PALISADE trial, we are building on our robust safety database of more than 1,000 AR101-treated patients, and are excited to start this important study of AR101 to examine the potential treatment benefit for younger children who need a path to protection that matters,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune Therapeutics. “We intend to submit regulatory filings for marketing approval of AR101 in the United States and Europe in 4–17-year-olds based on the positive data from the PALISADE clinical trial, which met its primary and key secondary endpoints, as well as data from additional ongoing and completed AR101 clinical trials.”
The primary efficacy endpoint for POSEIDON is tolerating a 600-mg single dose of peanut protein (the equivalent of approximately two peanut kernels) with no more than mild symptoms in a progressive, exit, double-blind, placebo-controlled food challenge (DBPCFC) after approximately one year of treatment.
“Food allergies are a growing, potentially life-threatening condition with no approved treatments, and peanut allergy, which is often diagnosed in the first or second year of life, is one of the most common food allergies, affecting more than six million people in the United States and Europe,” said Brian Vickery, M.D., Associate Professor of Pediatrics at Emory University and Founding Director of the Food Allergy Center at Children’s Healthcare of Atlanta, member of the Aimmune Scientific Advisory Board, and Principal Investigator for the POSEIDON trial. “This trial represents the critical next step not only in validating that early immunotherapy in young peanut-allergic children is safe and highly effective, but in generating evidence that, pending approval, AR101 can be smoothly incorporated into allergists’ practices to address the needs of children who can benefit.”
POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 trial to evaluate the efficacy and safety of AR101 in peanut-allergic children ages 1–3 in five countries in North America and Europe. Enrollment will be based on stringent entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and a double-blind, placebo-controlled food challenge (DBPCFC). In POSEIDON, patients will undergo a dose escalation period of approximately 22 weeks to reach a dose of 300 mg per day of AR101 or placebo, then continue on that dose for approximately six months. During treatment, the trial will allow treating physicians to use prophylactic antihistamines at their discretion as is customary in clinical practice. At the end of the trial, patients will undergo an exit DBPCFC.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral immunotherapies 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, and the company expects to file its biologics license application, or BLA, for AR101 for that age group by the end of 2018. For more information, please visit 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, including in young peanut-allergic children; Aimmune’s expectations regarding the anticipated timing of any future clinical trials; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 for peanut allergy in the United States and Europe, including the timing of these submissions; Aimmune’s expectations regarding the potential commercial launch of AR101; 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 an investigational product that is under clinical development and that has not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). It is currently limited to investigational use, and no representation is made as to its safety or effectiveness for the purposes for which it is being investigated.
Laura Hansen, Ph.D.