BRISBANE - Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical company developing and bringing new treatments to people with potentially life-threatening food allergies, today announced new data from the clinical development program for PALFORZIA [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first peanut allergy treatment approved by the U.S. Food and Drug Administration (FDA).

An analysis from ARC004, the open-label follow-on trial to the 52-week PALISADE trial, showed that patients tolerated more peanut protein, experienced fewer adverse events and continued immunomodulation - changes in the body's immune system - as evidenced by reductions in peanut-specific immunoglobulin (IgE) blood levels after an additional 56 weeks of daily treatment with PALFORZIA. These data were accepted for presentation at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting; due to the cancellation of the meeting, the Company will host a conference call Monday, March 16 at 12:15 p.m. ET to discuss the data, and posters will be available on Aimmune's website prior to the call.

Additional data announced include: An analysis of patient baseline characteristics and associated treatment response which demonstrated that all subgroups experienced clinically meaningful treatment effects during the PALISADE trial with PALFORZIA.

A survey that assessed quality of life (QoL) of PALFORZIA-treated patients aged 8 to 17 who were followed for an additional 28 or 56 weeks of therapeutic dosing in the open-label extension trial to PALISADE, ARC004, that suggested clinically significant improvements in emotional and social impacts of peanut allergy after long-term treatment with PALFORZIA.

Three additional quality of life studies that reinforced the real-world burden and daily impact of peanut allergy on adolescents and caregivers in the U.S.

Findings from two real-world surveys of allergists and immunologists practicing oral immunotherapy (OIT) that revealed largely consistent practice patterns and indicated successful implementation of food allergy OIT in clinical practice.

PALFORZIA Long-term Clinical Trial Data

Patients who completed the 52-week PALISADE clinical trial and could tolerate at least 300 mg (443 mg cumulative) peanut protein at the exit double-blind, placebo-controlled food challenge (DBPCFC) were eligible to continue treatment with PALFORZIA (300 mg/day) for either 28 (cohort 1; n=103) or 56 weeks (cohort 3a; n=26) in the open-label follow-on trial ARC004.

The trial showed that the ability to tolerate cumulative doses of peanut protein was sustained or improved between PALISADE and ARC004, after an additional 28 or 56 weeks of treatment, and that an increased number of patients in both cohorts tolerated peanut protein doses of more than 300 mg during the ARC004 exit food challenge compared to the PALISADE exit food challenge.

During the exit food challenge of ARC004, four out of five (80.8%) of patients who completed the trial in cohort 3a were able to tolerate 2,000 mg (or 3,443 cumulative) of peanut protein (the equivalent of approximately 12 peanuts) after 56 weeks of continued dosing, and in cohort 1 (28 weeks of additional daily dosing) approximately half (49%) of patients tolerated 2,000 mg, suggesting progressive desensitization to peanut protein over time during treatment with PALFORZIA.

With continued daily dosing beyond one year, the number of related adverse events per patient-year of exposure dropped by 59% and 85% in cohorts 1 and 3a, respectively, from PALISADE to ARC004, and no deaths or life-threatening AEs were observed. In addition, as expected, immunomodulation continued over time, including a reduction in peanut-specific IgE below baseline in all patient subgroups.

Separately, survey results assessed the impact of PALFORZIA treatment on quality-of-life parameters, including allergen avoidance, dietary restrictions, risk of accidental exposure and emotional and social impact, in patients who completed PALISADE and were eligible to enroll into one of three dosing cohorts in the open label extension study, ARC004.

Patients completed an age-appropriate Food Allergy Quality of Life Questionnaire (FAQLQ) and Food Allergy Independent Measure (FAIM), and results across both questionnaires showed that overall self-reported quality of life measurements consistently exceeded the minimally important difference (MID) of 0.5 for total scores following the transition to open-label ARC004 at both 28 and 56 weeks of additional PALFORZIA therapeutic dosing, suggesting clinically significant improvements in emotional and social impacts of peanut allergy after long-term treatment with PALFORZIA.

In an analysis that aimed to determine whether baseline variables affect the immunological response to PALFORZIA, researchers calculated the proportion of PALISADE study participants aged four through 17 years who achieved the primary endpoint in the clinical trial (tolerating 600 mg peanut protein at DBPCFC) based on age, sex, asthma, peanut-related anaphylaxis history, allergic rhinitis, multiple food allergies and atopic dermatitis.

Overall, the difference in the primary endpoint between PALFORZIA and placebo was 63.2% and in all subgroups the difference exceeded 55%.

While all patient subgroups experienced clinically meaningful treatment effects with PALFORZIA, trends toward higher desensitization rates exceeding 70% were observed for some variables, including female gender and no history of asthma or anaphylaxis.

Peanut Allergy Data

Data from the Peanut Allergy Burden Study (PABS), which assessed the real-world burden of peanut allergy on adolescents (aged 13 to 17) and caregivers in the U.S. using the validated Pediatric Quality of Life Inventory (PedsQL) showed that adolescents with peanut allergy have lower PedsQL scores than a general population of 8 to 16-year-olds.

Adolescents experiencing one or more peanut allergy-related reactions in the past year had a lower PedsQL, as did those receiving clinician intervention for one or more peanut allergy reactions in the past year.

A second PABS assessment of the real-world burden of peanut allergy on adolescents using the Food Allergy Quality of Life Questionnaire (FAQLQ) showed that adolescents with peanut allergy are constantly impacted by a number of psychosocial variables, including living with the fear of a reaction on emotional well-being, daily life limitations, worry regarding epinephrine autoinjector access, confidence managing a reaction, and the severity of their most severe reaction.

A third PABS assessment evaluated the real-world burden of peanut allergy on adolescents and caregivers of adolescents aged 13 to 17 with peanut allergy using the FAQLQ.

Results showed that adolescents reported a significantly greater burden than caregivers on the limitations that peanut allergy placed on their day-to-day life, noting a fear of a reaction impacting emotional well-being and poorer quality of life.

Adolescents also differed significantly from caregivers on the most concerning aspects of peanut allergy, with adolescents expressing more concern regarding physical symptoms during a reaction and the impact of peanut allergy on family.

Nearly one-third more adolescents also reported greater concern regarding the impact of PA on their mental health than did caregivers; more than one-third more adolescents than caregivers reported physical symptoms experienced during a reaction as most concerning, and twice as many adolescents reported impact on their family as most concerning.

About Aimmune

Aimmune Therapeutics, Inc. is a biopharmaceutical company developing and bringing new treatments to people with 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 the potential benefits of PALFORZIA; the potential for PALFORZIA to increase desensitization over time and to improve patient quality of life 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 dependence on the success of PALFORZIA; Aimmune's ability to build a commercial field organization and distribution network; the degree of acceptance of PALFORZIA among physicians, patients, healthcare payors, patient advocacy groups and the general medical community; Aimmune's ability to obtain favorable coverage and reimbursement from third-party payors for PALFORZIA; Aimmune's reliance on third parties for the manufacture of PALFORZIA; Aimmune's ability to implement and comply with the REMS for PALFORZIA; 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 Annual Report on Form 10-K for the year ended December 31, 2019. 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 (AR101), 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. AR101 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.

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