Core Viewpoint - RAPT Therapeutics has initiated a Phase 2b clinical trial for ozureprubart, targeting IgE-mediated food allergies, marking a significant milestone in the development of new therapies for this growing health issue [1][2]. Company Overview - RAPT Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel therapies for inflammatory and immunological diseases [7]. - The company aims to provide improved anti-IgE therapies for patients suffering from food allergies and other allergic inflammatory diseases [5][6]. Clinical Trial Details - The prestIgE Phase 2b trial will involve approximately 30 sites across the U.S., Canada, and Australia, assessing the efficacy and safety of ozureprubart in participants with IgE-mediated food allergies [1][3]. - The trial is designed as a two-part, multi-center, randomized, double-blind, placebo-controlled study, comparing two dosing regimens of ozureprubart to placebo [3]. - In Part 1, around 100 participants with food allergies will be treated for 24 weeks, with the primary endpoint being the proportion of participants achieving a target threshold in a double-blind oral food challenge at Week 24 [3]. - Part 2 will continue treatment for an additional 24 weeks, with participants on placebo re-randomized to receive ozureprubart [3]. Product Information - Ozureprubart is a novel, half-life extended anti-IgE monoclonal antibody designed to inhibit free and cell-bound IgE, which is a key driver of allergic diseases [5][6]. - It targets the same epitope as omalizumab but aims to offer improved durability and reduced dosing frequency [2][5]. Industry Context - Food allergies are a significant and increasing health concern, with over 17 million diagnosed individuals in the U.S., including approximately 3.5 million children [4]. - The prevalence of food allergies is rising, with many individuals allergic to multiple foods and experiencing severe reactions [4].

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]