Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing CODIT™ (Characterized Oral Desensitization ImmunoTherapy) treatments for life-threatening food allergies, today announced that additional safety and tolerability data from the extended maintenance period of the ongoing, open-label Phase 2 continuation trial of Aimmune’s lead investigational product, AR101 for the treatment of peanut allergy, will be featured during a late-breaker oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2016 in Vienna. Dr. Rima Rachid from the Division of Allergy and Immunology, Harvard Medical School and Boston’s Children’s Hospital, will give the presentation on Monday, June 13, 2016 (Abstract #2362). Aimmune will host a conference call and live audio webcast on Monday, June 13, 2016, at 4:00 p.m. Eastern Time to discuss the results.
“Just one year ago at EAACI, we presented positive efficacy and safety data from our first Phase 2 study of AR101 for peanut allergy. Since then, we’ve seen those data confirmed in our crossover/rollover study, and we’ve identified potential biomarkers to help predict treatment success,” said Aimmune CEO Stephen Dilly, M.B.B.S., Ph.D. “Now that we have patients who have been treated for nearly two years, we’re excited to return to EAACI and to present findings on safety and tolerability in longer-term maintenance therapy.”
Late-Breaker Oral Presentation Details
|Title:||The safety and tolerability of AR101, an oral immunotherapy (OIT) pharmaceutical formulation for peanut allergy, after more than one year of treatment (abstract #2||362)|
|Presenter:||Dr. Rima A. Rachid, Assistant Professor of Pediatrics|
|Harvard Medical School and Boston Children’s Hospital, Division of Allergy and Immunology|
|Date:||Monday, June 13, 2016|
|Time:||4:34 – 4:47 p.m. Central European Time|
|(10:34 a.m. – 10:47 a.m. Eastern Time)|
|Session:||Late-Breaking Oral Abstract Session (LB OAS 4)|
|Determination of Severity and Treatment of Food Allergy|
|3:45 – 5:15 p.m. Central European Time|
|Location:||Messe Wien Exhibition & Congress Center|
All abstracts for the EAACI Congress 2016 will be available online one day prior to the start of the Congress.
Conference Call on Monday, June 13, 2016, at 4 p.m. Eastern Time
The conference call will be accessible via the company’s website at www.aimmune.com on the Events page under Investor Relations. Please connect to the company’s website at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, participants may dial (877) 497-1438 (domestic) or (262) 558-6296 (international) and refer to conference ID 27715872.
The archived conference call will be available on Aimmune’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event. For a telephone replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and refer to conference ID 27715872.
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™) system, an approach to oral immunotherapy (OIT), uses rigorously characterized product candidates with gradual, controlled up-dosing protocols to obtain clinically meaningful desensitization to food allergens. Aimmune’s first CODIT product, 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 Phase 3 trial of AR101, PALISADE, is now enrolling patients. 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 2 trial results, including safety and tolerability of longer-term maintenance therapy with AR101; Aimmune’s expectations regarding the potential benefits of AR101; Aimmune’s expectations of the value of having a predictive biomarker test for treatment response of AR101; and Aimmune’s expectation that additional safety and tolerability data from the extended maintenance period of the ongoing, open-label Phase 2 continuation trial of AR101 will be featured during a late-breaker oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2016 in Vienna on June 13, 2016. 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 Form 10-Q for the quarter ended March 31, 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.