First Patients Receive Aimmune Therapeutics' Peanut Allergy Treatment Palforzia

The first US patients with peanut allergy have been treated with Aimmune Therapeutic’s Palforzia (Peanut [Arachis hypogaea] Allergen Powder-dnfp) the company announced in a in a statement. The oral immunotherapy treatment (OIT) was approved by the FDA in January, and is the first approved treatment for patients with peanut allergy.

Palforzia aims to mitigate allergic reactions, including anaphylaxis. Patients initially ingest allergenic proteins in very small quantities, then amounts incrementally increase, resulting in the ability to tolerate allergic reactions over time.

Specialty pharmacies have begun shipping initial dosing kits of the OIT to allergists for in-office administration to patients aged 4 to 17 who have a confirmed diagnosis of peanut allergy. Up-dosing and maintenance also take place during an office visit and may be continued in patients aged 4 and older.

The treatment must be administered in person, but Joel Hartman, MD, of Allergy Partners of the Piedmont, stressed the process does not have to be intrusive to everyday workflow. “We have a day carved out where we do oral immunotherapy in and amongst our normal workflow,” Hartman said during an Aimmune phone conference. “What we’ve found is that most physicians have the tools and the resources they need” to administer the treatment. However, in the wake of the COVID-19 pandemic, physicians on the call stressed they are trying to minimize non-urgent office visits for the time being.

Currently, the treatment is only available through a restricted program under an FDA-mandated Risk Evaluation and Mitigation Strategy (REMS), due to 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,” according to the company.

The REMS website was launched at the end of February, and since then over 600 allergists have been certified to prescribe the treatment. “Our field team is continuing to meet with allergists to provide direction and information on the REMS process to help additional physicians and practices become certified and provide training on how to safely incorporate Palforzia into their practices,” said Jayson Dallas, MD, president and chief executive officer of Aimmune. Certified distributers are listed here.

This announcement comes after additional data was released this week on Palforzia. The data was originally scheduled to be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2020 Annual Meeting, which was cancelled due to the novel coronavirus.

An analysis of ARC004, the open-label follow-on trial to the 52-week Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADE) trial, shows the treatment leads to increased desensitization, improved tolerability, and continued immunomodulation after 18 and 24 months of treatment.

Specifically, researchers found “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.”

The follow-on trial yielded the additional findings:

• 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.
• An increased number of patients in both cohorts tolerated peanut protein doses of more than 300 mg during the ARC004 exit food challenge compared with the PALISADE exit food challenge.
• 80.8% of patients who completed the trial in cohort 3a were able to tolerate 2000 mg (or 3443 cumulative) of peanut protein (the equivalent of approximately 12 peanuts) after 56 weeks of continued dosing.
• In cohort 1 (28 weeks of additional daily dosing) 49% of patients tolerated 2000 mg, suggesting progressive desensitization to peanut protein over time during treatment with palforzia.
• With continued daily dosing beyond 1 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 adverse events were observed.
• 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.

When it comes to patient treatment access, the company stated, “Aimmune will provide resources to patients and families who, upon consultation with their physician, wish to seek treatment with palforzia. These resources will include educational materials, a dedicated call center, a co-pay program for eligible patients, and a Patient Assistance Program to provide palforzia at no cost to eligible patients.”

Approximately 1 million children in the United States are affected by peanut allergy, and only 1 in 5 children will outgrow it, according to Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research. As there is no cure for the allergy, living with the condition can lead to significant burdens among patients and caregivers.

“As physicians or clinicians taking care of patients, we understand how profoundly this diagnosis affects obviously the patient, but also the caregivers and the entire family,” said Anna Nowak-Węgrzyn, MD, PhD, a professor of pediatrics at the New York University School of Medicine, in an interview with The American Journal of Managed Care^®. “Food allergy is a disease that is really unique, in a sense that you're not sick all the time. But you're living with the potential for a life-threatening, catastrophic event at every minute, every second of your life, so it's really very unique.” With regard to the most recent palforzia trial results, Nowak-Węgrzyn, (included on the Aimmune call) said, "This is very, very big...This is a major gain for both children and caregivers."

Aimmune hopes to mitigate these burdens in part through the use of palforzia, which will mitigate environmental risk factors faced by children. “Additional studies…further reinforce the daily burden of living with peanut allergy and suggest that treatment with palforzia may improve its emotional and social impact on adolescents and caregivers alike,” said Daniel Adelman, MD, chief medical officer of Aimmune Therapeutics.