ozureprubart (RPT904)
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RAPT Therapeutics Initiates prestIgE Phase 2b Clinical Trial of Ozureprubart (RPT904) in Patients with Food Allergies
Globenewswireยท 2025-10-27 12:00
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].