BRISBANE, Calif. & HELSINKI--(BUSINESS WIRE)--Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing treatments for life-threatening food allergies, today reported findings from pre-randomization, preliminary clinical data collected from the European screening population of the PALISADE trial in Aimmune’s AR101 program. In addition, the company reported observations from a survey on current management and use of oral immunotherapy for peanut allergy across Western Europe. The data were presented at the 2017 European Academy of Allergy and Clinical Immunology (EAACI) Congress in Helsinki.
AR101 is Aimmune’s investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. The Phase 3 PALISADE trial of AR101 enrolled 554 peanut-allergic patients ages 4–49 in eight countries in Europe and in the United States and Canada.
“Food allergy is a growing problem in Europe, with a high unmet medical need due to the potential severity of reactions, the difficulty of avoiding trace amounts of the food and the resulting anxiety that leads to reduced quality of life,” said Sue Barrowcliffe, General Manager of Aimmune Europe. “Consequently we were delighted to have been able to include eight EU countries and more than 100 patients in our Phase 3 PALISADE trial, including many with multiple food allergies. The screening data from these patients that we have presented at EAACI provide an interesting insight into the characteristics of patients who are sensitive to very small amounts of peanut protein. Once the trial is completed, we will also be able to examine in detail the links between baseline characteristics and outcomes, from both an efficacy and a safety perspective.”
Aimmune presented a preliminary dataset of 166 patients in Europe who underwent a screening double-blind, placebo-controlled food challenge (DBPCFC) to determine eligibility for the PALISADE trial (57% ages 4–11, 28% ages 12–17, and 15% ages 18–55; 59% male). The DBPCFC allowed a progression of doses of peanut protein up to a dose of 100 mg (1 mg, 3 mg, 10 mg, 30 mg, and 100 mg). Patients who reacted with dose-limiting symptoms at or before the 100-mg dose (“reactors”) were eligible for randomization into the trial.
Observations from preliminary evaluable baseline characteristics results from these patients included the following:
- Sixty-two percent of the subjects screened were reactors, who experienced dose-limiting symptoms in the DBPCFC at or before the 100-mg dose (median = 30 mg dose, meaning a cumulative amount of 44 mg peanut protein); 38% were “non-reactors” who consumed all doses in the DBPCFC with no dose-limiting symptoms
- Reactors had a statistically significant larger peanut skin-prick test (SPT) wheal diameters, a higher peanut-specific IgE (psIgE) and higher Ara h 2–specific IgE than non-reactors. Ara h 2–specific IgE demonstrated greatest sensitivity and specificity for discriminating between reactors and non-reactors, based on receiver operating characteristic (ROC) curve analysis of the data
- SPT, peanut-specific IgE and Ara h 2 were not associated with the severity of reactions during the screening DBPCFC
“We are looking forward to analyzing the full European and North American dataset from PALISADE to learn more about the relationships between baseline measurements and reactions to peanut, as well as to explore geographic differences in the peanut-allergic populations and their management,” said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. “These data, along with those from the other studies in our AR101 program, provide valuable information that helps determine the most appropriate practical use of AR101 on a large scale. We are particularly interested in seeing the screenings for the Phase 3 ARTEMIS trial for peanut-allergic children and adolescents in Europe, which will include patients who react at or before a 300-mg dose of peanut protein.”
Aimmune also presented the results from a survey of physicians across six Western European countries who offer oral immunotherapy to peanut-allergic patients. Interviews with 39 physicians revealed substantial variability in approaches for peanut oral immunotherapy within and across European countries, showing that there is currently no standardized approach or product for peanut oral immunotherapy in Europe.
The posters associated with the abstracts “Clinical and immunologic characteristics of European patients screened for PALISADE” (#0371, Vereda A, et al.) and “Current Management and Use of Oral Immunotherapy for Peanut Allergy Across Western Europe” (#1369, Radwan A, et al.). are available at www.aimmune.com in the Events section under the News & Events tab.
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 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 is currently being evaluated in Phase 3 clinical trials. 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 the potential predictive value of biomarkers for AR101; Aimmune’s expectations for its PALISADE and ARTEMIS trials of AR101; Aimmune’s expectations regarding the potential benefits 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; 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. 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.