BRISBANE, Calif. --(BUSINESS WIRE)--
Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced that it has completed global enrollment of its Phase 3 PALISADE trial of AR101 for the treatment of peanut allergy, with the total randomized to the trial expected to be approximately 540 patients. AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
Aimmune continues to expect topline data from PALISADE in the fourth quarter of 2017, followed by regulatory submissions for marketing approval of AR101 in 2018 in both the United States and Europe. The company announced completion of North American enrollment in PALISADE in September, ahead of schedule and above target enrollment.
Aimmune also announced ARTEMIS (AR101 Trial in Europe Measuring oral Immunotherapy Success), a new dedicated European clinical trial of AR101 in peanut-allergic children and adolescents. ARTEMIS is designed to expand the data available on the efficacy profile of AR101 by exploring a higher level of protection after a shorter treatment period in a broader group of patients (in terms of baseline reaction) than in PALISADE. The primary efficacy endpoint in this new trial will be tolerating a cumulative amount of 2,043 mg of peanut protein in an exit double-blind, placebo-controlled food challenge (DBPCFC) after approximately nine months of treatment with AR101.
“PALISADE remains the cornerstone of our AR101 program, and the completion of global enrollment is a significant milestone. Now that the $145 million investment in Aimmune by Nestlé Health Science has closed, we have additional resources to further strengthen our development strategy,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “As previously announced, the RAMSES study, slated to begin in the United States in early 2017, is expected to provide important experience of AR101 in a ‘real-life’ clinical setting, building on our observation that removal of the baseline food challenge may meaningfully improve the tolerability of the early stages of AR101 treatment. We expect to file our biologics license application (BLA) on successful completion of PALISADE and RAMSES.
“With ARTEMIS, we are building on the observation that a very high proportion of patients in our ARC002 trial were desensitized to more than two grams of peanut protein at the nine-month endpoint. ARTEMIS is designed to confirm that finding in a double-blind, placebo-controlled setting,” said Dr. Dilly. “Demonstrating reliable, early desensitization with AR101 to such high levels would cement the utility of our low-dose, CODIT maintenance regimen. Furthermore, tolerating more than two grams of peanut protein would give patients an additional safety net in cases of accidental exposure, well after the threshold where they may taste peanut, which could offer greater reassurance and peace of mind. We expect to include the ARTEMIS results in our initial marketing authorization application in Europe.”
Sue Barrowcliffe, General Manager of Aimmune Europe, commented: “In Europe, we have seen great demand across multiple countries to be included in the global PALISADE trial, so we are very excited to conduct ARTEMIS as a dedicated European trial. It will offer a wider range of children and adolescents with peanut allergy the opportunity to participate in our clinical development program, and it will help to enhance our knowledge about the timing and extent of desensitization offered by AR101 treatment. As we have engaged with more stakeholders across Europe, we have also come to appreciate that confirming a higher efficacy reached sooner would be important in obtaining labeling for protection against accidental exposure and supporting reimbursement applications for AR101, especially as we see increased focus on cost effectiveness throughout Europe.”
ARTEMIS is a randomized, double-blind, placebo-controlled trial in peanut-allergic children and adolescents ages 4-17. The inclusion criteria for the trial will allow for baseline toleration of a cumulative amount not exceeding 144 mg of peanut protein in an entry DBPCFC (i.e., reacting at or before a cumulative amount of 444 mg of peanut protein, at the 300 mg dose of the challenge). Patients will undergo approximately six months of up-dosing and then three months of maintenance therapy at 300 mg of AR101 per day, followed by an exit DBPCFC. Aimmune expects ARTEMIS to enroll between 120 and 160 patients at multiple sites in Europe, beginning in mid-2017.
About Aimmune Therapeutics
Aimmune Therapeutics, Inc., is a clinical-stage biopharmaceutical company developing treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to achieve meaningful levels of protection by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first investigational 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 is currently being evaluated in Phase 3 clinical trials in ages 4-55. AR101 is a characterized, regulated, oral biological drug product containing the protein profile found in peanuts. 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 for its Phase 3 PALISADE trial of AR101, including its expected size and timing of topline data; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations regarding the sufficiency of its capital resources; Aimmune’s expectations for the RAMSES and ARTEMIS studies, including the timing of the trials; Aimmune’s expectations on regulatory submissions for marketing approval of AR101 in the United States and Europe, including the timing of these submissions; 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; 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; Aimmune’s dependence on the success of AR101; the company’s reliance on third parties for the manufacture of the company’s product candidates; possible regulatory developments in the United States and foreign countries; and the company’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 Annual Report on Form 10-K for the year ended 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. 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 a product that is under clinical investigation 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.
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