Aimmune announced that the first US patients are being treated with Palforzia™ (Peanut [Arachis hypogaea] Allergen Powder-dnfp), an oral immunotherapy for peanut allergy. 

In January 2020, Palforzia was approved by the Food and Drug Administration (FDA) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. It is approved for use in patients with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. Treatment with Palforzia may be initiated in patients aged 4 to 17 years.

Palforzia is shipped by specialty pharmacies to clinicians for in-office administration only. It may only be administered by allergists that have been certified under a Risk Evaluation and Mitigation Strategy (REMS) program. “Since our REMS website went live on February 21, well over 600 allergists are certified and ready to prescribe Palforzia to their patients,” said Jayson Dallas, MD, President and CEO of Aimmune.

The Company also recently announced additional data from an open-label follow-on trial (ARC004) to the 52-week phase 3 PALISADE trial. The study, which included patients who completed the PALISADE trial and could tolerate at least 300mg of peanut protein at the exit double-blind, placebo-controlled food challenge (DBPCFC), allowed participants to continue treatment with Palforzia 300mg daily for either 28 (cohort 1; n=103) or 56 weeks (cohort 3a; n=26).  

Results showed that patients were able to tolerate cumulative doses of peanut protein in both cohorts, with an increased number of patients tolerating peanut protein doses of >300mg during the ARC004 exit food challenge compared with the PALISADE exit food challenge. During the ARC004 exit food challenge, 80.8% of patients in cohort 3a (additional 56 weeks of treatment)  and 49% of patients in cohort 1 (additional 28 weeks of treatment) were able to tolerate 2000mg of peanut protein, suggesting progressive desensitization with treatment. Moreover, continued immunomodulation was observed over time, including a reduction in peanut-specific IgE below baseline in all patient subgroups.

Additionally, subgroup analysis showed that certain variables were associated with trends toward higher desensitization rates exceeding 70%; these included female gender and no history of asthma or anaphylaxis. Further analysis showed clinically significant improvements in quality of life based on patient survey results.

Regarding safety, the number of related adverse events per patient-year of exposure decreased with continued daily dosing by 59% and 85% in cohorts 1 and 3a, respectively. There were no deaths or life-threatening adverse events reported in ARC004.

“We are excited to share new long-term Palforzia data, which indicate that as patients remain on treatment, the immune system appears to develop an increased tolerance to the allergen, as demonstrated by the reduced frequency and severity of side effects, along with the potential for continued desensitization over time,” said Daniel Adelman, MD, Chief Medical Officer of Aimmune Therapeutics.

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