RAPT Therapeutics Announces FDA Clearance of IND Application to Proceed to Phase 2b Trial of RPT904 in Food Allergy

Core Insights - RAPT Therapeutics has received FDA clearance for its IND application to initiate a Phase 2b clinical trial of RPT904 for food allergies, marking a significant advancement in the company's clinical development efforts [1][2] Company Overview - RAPT Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for inflammatory and immunological diseases [5] Clinical Trial Details - The Phase 2b trial, named "prestIgE," will evaluate the safety and efficacy of RPT904 in patients with IgE-mediated food allergies, comparing two dosing regimens (every 8 weeks and every 12 weeks) against a placebo [3] - Approximately 100 participants with food allergies (peanut, milk, egg, walnut, or cashew) will be enrolled, with the primary endpoint being the proportion of participants achieving a target threshold in a double-blind, placebo-controlled oral food challenge at Week 24 [3] - The trial will consist of two parts, with participants receiving treatment for a total of 48 weeks, followed by a 16-week safety follow-up period [3] Product Information - RPT904 is a next-generation, half-life extended anti-IgE monoclonal antibody designed to inhibit free and cell-bound IgE, which is a key driver of allergic diseases [4] - The product aims to provide a differentiated therapeutic option compared to the first-generation anti-IgE monoclonal antibody, omalizumab [4]