Aimmune Therapeutics, Inc. announced new two-year data that suggest long-term efficacy of daily treatment with PALFORZIA™ [Peanut (Arachis hypogaea) Allergen Powder-dnfp] in patients with peanut allergy. Patients dosed daily in the study also showed ongoing immunomodulation and higher rates of desensitization that increased over time compared to those patients who were administered non-daily dosing. Furthermore, the majority of patients in the daily dosing groups reported lower adverse event (AE) rates compared to those in the non-daily dosing groups, with an overall safety profile of long-term daily dosing with PALFORZIA that was better than non-daily dosing. These two-year results from ARC004, a follow-on study to the pivotal phase 3 PALISADE trial, were presented during the digital European Academy of Allergy and Clinical Immunology. A greater proportion of patients who continued daily long-term dosing with PALFORZIA in ARC004 completed the study compared to those patients in the non-daily treatment groups. Furthermore, after two years of daily treatment with PALFORZIA, more than 80% of patients undergoing the food challenge demonstrated desensitization to 2000 mg peanut protein (4043 mg cumulatively [equivalent to 14 peanut kernels]). Desensitization rates associated with PALFORZIA treatment were higher in the daily dosing groups compared to the non-daily dosing groups; within the daily dosing groups, desensitization rates improved with duration of therapy. Changes in immunologic measures showed ongoing immunomodulation during the first two years of treatment with PALFORZIA with further modulation of immunologic and improvement in clinical parameters in subsequent years anticipated to occur. Patients in the two daily dosing groups also reported fewer treatment-related adverse events (TRAE) when adjusted for the number of patient-years of exposure compared to the three non-daily dosing groups. Adverse events in the daily dosing groups were mostly mild to moderate with only three patients reporting severe events observed in over 100 patient-years of exposure. The overall rate of AE-related discontinuations was low but slightly higher in the longer-term non-daily dosing groups. Across treatment groups, PALFORZIA appeared to be well tolerated and was consistent with previous studies with no new safety concerns.