Aimmune Therapeutics : New Data Show Patients Are Highly Satisfied With and Confident in the Efficacy of Daily Treatment with PALFORZIA after Nine Months

BRISBANE - Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies, today announced new findings from the phase 3 ARTEMIS trial that show patients with peanut allergy aged 4 through 17 were highly satisfied after nine months of daily treatment with PALFORZIA, the first therapy approved by the U.S. Food and Drug Administration (FDA) for peanut allergy.

Specifically, the report revealed that patients were confident that the treatment was effective, convenient to incorporate into their daily lives, and easy to administer.

These data were presented during the digital European Academy of Allergy and Clinical Immunology (EAACI) Congress and are available for on-demand viewing at EAACI scientific programme website.

'We are encouraged to see the majority of participants completing the nine-month ARTEMIS trial reported high global satisfaction with daily treatment with PALFORZIA, high confidence in the treatment, and moderate-to-high satisfaction with the convenience of the treatment,' said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. 'Hearing from patients directly is important for us to better understand the effects this treatment can have on their lives. The study participants felt treatment with PALFORZIA in the ARTEMIS trial was effective, which may help them better manage their peanut allergy and live their lives more confidently. Our hope is that these data will reassure families who may be considering treatment with PALFORZIA to help them make important shared treatment decisions with their allergists.'

Patient-reported treatment satisfaction was evaluated after nine months of daily treatment with PALFORZIA in a clinical trial setting using the Treatment Satisfaction Questionnaire for Medication (TSQM-9), a validated instrument used in a variety of disease states. Participants reported high mean total scale scores for effectiveness and satisfaction and moderate scores for convenience, indicating that patients were overall satisfied with this treatment and the daily dosing approach.

PALFORZIA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as an oral immunotherapy for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis of peanut allergy. In Europe, Aimmune's marketing authorization application for AR101 is under review with the European Medicines Agency (EMA). A Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 also is ongoing.

About the ARTEMIS Self-Reported Treatment Satisfaction Findings

The ARTEMIS study is a Phase 3, randomised, double-blind, placebo-controlled trial evaluating PALFORZIA in peanut-allergic individuals aged 4-17 years in Europe. In the study, patients received daily doses of PALFORZIA or placebo that were escalated every two weeks over approximately six months until a maintenance dose of 300 mg/day was reached, and underwent an exit food challenge after approximately three months of therapeutic maintenance dosing; patient-reported treatment satisfaction was included as an exploratory endpoint. 111 PALFORZIA-treated patients completed a Treatment Satisfaction Questionnaire for Medication (TSQM-9), a validated questionnaire designed to assess patient-reported treatment satisfaction with a medication that consists of nine questions across three domains global satisfaction, convenience, and effectiveness. Baseline characteristics were well-balanced between the PALFORZIA- and placebo-treated groups and typical of a highly atopic peanut-allergic population.

About Aimmune

Aimmune Therapeutics, Inc. is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. With a mission to improve the lives of people with food allergies, Aimmune is developing and commercializing oral treatments for potentially 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 has one FDA-approved medicine for peanut allergy and other investigational therapies in development to treat other food allergies.

Forward-Looking Statements

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 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 risk that the COVID-19 worldwide pandemic may continue to negatively impact the business, research and clinical operations of Aimmune or its partners; 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 PALFORZIA; Aimmune's reliance on third parties for the manufacture of Aimmune's products and 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 March 31, 2020. 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 PALFORZIA, which has been approved for marketing by the FDA in the United States and has not been approved for marketing by the EMA or Swissmedic. PALFORZIA in Europe 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.

Contact:

Tel: [phone]

Email: [e-mail]

(C) 2020 Electronic News Publishing, source ENP Newswire