The Mortgage broker Oak Laurel Nundah presentations included Phase 3 screening data and Phase 2 adherence data from Aimmunes AR101 program. AR101 is Aimmunes investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. As we work to bring AR101 through clinical trials with the aim of providing physicians and patients with a desensitization treatment for peanut allergy, we are also committed to contributing to the scientific understanding of food allergy, said Daniel Adelman, M.D., Chief Medical Officer of Aimmune. Our Phase 3 program constitutes the largest dataset available in peanut-allergic patients and supports the exploration of fundamental immunologic mechanisms of desensitization and immunomodulation. Aimmunes late-breaking abstract presented baseline characteristics from 583 peanut-allergic patients who were screened to determine eligibility for the Phase 3 PALISADE trial in North America. Among the inclusion criteria, a double-blind, placebo-controlled food challenge (DBPCFC) administered at screening allowed a progression of doses of peanut protein up to a dose of 100 mg (1 mg, 3 mg, 10 mg, 30 mg, and 100 mg). Subjects who reacted with dose-limiting symptoms at or before the 100 mg dose (reactors) were eligible for randomization into the trial. This unique dataset of screening DBPCFCs is the largest ever collected on peanut-allergic patients in the clinical trial context and yielded the following observations and insights: 457 patients (78%) were reactors, who experienced dose-limiting symptoms in the DBPCFC at or before the 100 mg dose (median = 44 mg cumulative amount of peanut protein); 116 subjects (20%) were non-reactors who consumed all 144 mg in the DBPCFC with only mild symptoms or no symptoms at all; 10 subjects (2%) reacted to placebo Reactors demonstrated higher baseline peanut-specific IgE (psIgE) and Ara h2-specific IgE levels and larger peanut skin prick test (SPT) wheal diameters than non-reactors, and psIgE appeared to provide the greatest utility to discriminate between reactors and non-reactors The median psIgE in reactors was 70.2 kUA/L, compared with 5.3 kUA/L in non-reactors (a threshold psIgE of 19.25 kUA/L showed the greatest sensitivity and specificity for predicting reactors) Sensitivity to peanut and severity of symptoms during screening DBPCFCs were not closely linked, and neither was associated with baseline immune parameters or age In general, our findings build on the published literature and highlight the clinical and immunologic heterogeneity among patients with peanut allergy, said Dr. Adelman. More specifically, insights on our PALISADE screening population are helping to guide our clinical development strategy and design of future AR101 clinical trials. In our PALISADE screening analysis, we saw that psIgE was a valuable predictor of whether or not patients would react at or before the 100 mg dose of peanut protein.
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