Aimmune Presents New Clinical Data From Pooled Safety Analysis in Patients Treated With PALFORZIA® for up to ~3.5 Years

Aimmune Therapeutics, a Nestlé Health Science company developing and commercializing treatments for potentially life-threatening food allergies, today announced new clinical data from a pooled analysis of three controlled phase 3 (PALISADE¹, RAMSES, ARTEMIS²) and three open-label extension (ARC004³, ARC008, ARC011) trials of PALFORZIA^® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]. These data will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Virtual Annual Meeting held February 26 – March 1, 2021.

In patients with peanut allergy (ages 4 through 17) who continued daily treatment with PALFORZIA for up to 3.5 years reported adverse events were mostly mild, occurred early on in treatment, and declined over the course of treatment. With longer-term treatment, systemic allergic reactions and epinephrine use were rare and continued to decrease with treatment.

"As a practicing allergist, I have seen firsthand the burden that peanut allergy has on children and their families, significantly restricting their daily activities as they try to avoid accidental exposure,” said Thomas Casale, MD, lead author of the analysis and professor of medicine at the University of South Florida. "These data provide insight into the long-term safety of PALFORZIA as a treatment option. It also highlights that in these clinical trials, severe allergic reactions associated with the treatment were uncommon – potentially a critical factor for patients and their allergists as they consider PALFORZIA as a treatment option.”

The findings being presented at AAAAI further build on the full results from ARC004, the open-label follow-on study to the pivotal phase 3 PALISADE trial of PALFORZIA, which were published in the Journal of Allergy & Clinical Immunology: In Practice, on December 31, 2020, and reported that long-term daily dosing with PALFORZIA was well tolerated, with no newly identified safety concerns. Furthermore, the data showed that continued daily treatment with PALFORZIA beyond one year in peanut-allergic patients (ages 4 through 17) resulted in sustained efficacy, was well tolerated with a favorable safety profile, and was associated with changes in blood levels of peanut-specific immunoglobulin E (IgE) and immunoglobulin G4 (IgG4) that suggest ongoing immunomodulation during the second year of treatment with PALFORZIA. High rates of desensitization were also observed, which improved over time; desensitization rates were highest in those receiving daily dosing of PALFORZIA for the longest duration (2 years).

"The pooled safety analysis presented at AAAAI represents the largest safety data set of patients treated for peanut allergy and continues to show that long-term daily treatment with PALFORZIA is well tolerated, with mostly mild to moderate adverse events occurring primarily during updosing and resolving as the patient desensitizes to the allergen,” said Stephen Tilles, M.D., Senior Director, Medical Affairs for Aimmune Therapeutics. "Across these six trials evaluating more than 1,100 patients, we further saw a consistent safety profile for PALFORZIA that indicates adverse events decline in frequency and severity with continued treatment, providing important insights for allergists, patients and caregivers to help facilitate discussions and decision-making around treatment with PALFORZIA.”

These data will be presented online in a poster presentation: #335: "Safety of Peanut (Arachis Hypogaea) Allergen Powder-dnfp in Children and Teenagers With Peanut Allergy: Pooled Analysis From Controlled and Open-Label Phase 3 Trials Over 3.5 Years”, Casale, T., et al.

Key highlights from the data presentation include:

• More than 3 out of 4 patients were able to achieve the 300mg maintenance dose of PALFORZIA (n=938), and more than half of all patients had received at least one year of treatment (n=755) as of July 31, 2020; 431 and 94 patients across the studies received 2 and 3 years of PALFORZIA treatment, respectively.
• Participants reported mild-to-moderate treatment-related adverse events (TRAEs) during the updosing phase (26.2% moderate, 57.9% mild) and decreased throughout the maintenance phase (1.4% moderate, 5.8% mild, at the end of year 3).
• The most frequently reported TRAEs were throat irritation, abdominal pain, and oral pruritis.
• Overall, 13.3% of trial patients discontinued participation due to adverse events, with gastrointestinal symptoms as the most common primary reason for withdrawal, most of which occurred during the first 6 months.
• Exposure-adjusted rates of systemic allergic reactions of any severity and epinephrine use were low during Year 1 and decreased in Years 2 and 3.
• Over a ~3.5-year treatment period, 14 participants (1.2%) experienced a treatment-related severe systemic allergic reaction.

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 December 2020, the European Commission (EC) approved PALFORZIA for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. Additionally, a Swiss Agency for Therapeutic Products (SwissMedic) review of AR101 is ongoing.

INDICATION

PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 4 through 17 years. Up-Dosing and Maintenance may be continued in patients 4 years of age and older.

PALFORZIA is to be used in conjunction with a peanut-avoidant diet.

Limitations of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.

IMPORTANT SAFETY INFORMATION

Boxed WARNING:

PALFORZIA can cause anaphylaxis, which may be life threatening and can occur at any time during PALFORZIA therapy.

Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.

Do not administer PALFORZIA to patients with uncontrolled asthma.

Dose modifications may be necessary following an anaphylactic reaction.

Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes.

PALFORZIA is available only through a restricted program called the PALFORZIA REMS.

CONTRAINDICATIONS

PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.

WARNINGS AND PRECAUTIONS

Anaphylaxis

PALFORZIA can cause anaphylaxis, which may be life threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered in a certified health care setting.

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.

Asthma

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

Eosinophilic Gastrointestinal Disease

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

Gastrointestinal Adverse Reactions

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.

ADVERSE REACTIONS

The most common adverse events reported in subjects treated with PALFORZIA (incidence = 5% and = 5% than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide at www.PALFORZIA.com.

For more information about PALFORZIA, please call 1-844-PALFORZ (1-844-725-3679) or visit www.PALFORZIA.com.

About Aimmune

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies and other food-mediated conditions, including gastrointestinal conditions. Aimmune has one FDA- and EU-approved medicine for peanut allergy and other investigational therapies in development. For more information, please visit www.aimmune.com.

About Nestlé Health Science

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and vitamins, minerals and supplements (VMS) brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people's lives, for a healthier today and tomorrow. www.nestlehealthscience.com.

PALFORZIA^®, AIMMUNE^® and AIMMUNE THERAPEUTICS^® are trademarks of Aimmune Therapeutics, Inc.

¹ N Engl J Med. 2018;379(21):1991-2001.
² Lancet Child Adolesc Health. 2020;4(10):728-739.
³ Allergy Clin Immunol Pract. 2020;S2213-2198(20):31361-1.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005357/en/