RAPT Launches Phase 2b Study Of Ozureprubart To Evaluate Efficacy And Safety In Food Allergy Patients

RAPT Therapeutics, Inc., a clinical-stage biopharmaceutical company specializing in immunology-based therapies, has announced the initiation of its Phase 2b prestIgE clinical trial evaluating ozureprubart (formerly RPT904) in patients with IgE-mediated food allergies. The randomized, double-blind, placebo-controlled study will be conducted across approximately 30 sites in the U.S., Canada, and Australia.

“Food allergies are a large and growing problem for millions of patients worldwide,” said Brian Wong, M.D., Ph.D., President and CEO of RAPT. “Initiating this trial is a significant milestone that reflects our strong execution, the validity of the early preclinical and clinical data generated by our partner, Jeyou, in China and our mission to provide patients with an improved anti-IgE therapy. We look forward to working with leading food allergists in the U.S., Canada and Australia to advance development of ozureprubart.”

The prestIgE Phase 2b trial aims to assess the efficacy and safety of ozureprubart as a monotherapy for individuals allergic to foods such as peanut, milk, egg, walnut, or cashew. The study includes two dosing regimens: subcutaneous injections every 8 weeks or every 12 weeks (with a loading dose at Week 2), compared with placebo in a 2:2:1 ratio. In Part 1, about 100 participants will be treated for 24 weeks, with the primary endpoint being the proportion of patients achieving a target threshold during a double-blind, placebo-controlled oral food challenge (DBPCFC) at Week 24.

Hugh Sampson, M.D., Kurt Hirschhorn Professor of Pediatrics at the Icahn School of Medicine at Mount Sinai and Director Emeritus of the Jaffe Food Allergy Institute, added, “As a half-life extended anti-IgE monoclonal antibody, ozureprubart has the potential to be a transformative new therapeutic option for patients with food allergies. Targeting the same epitope as omalizumab, ozureprubart is a bio-better that is designed to match omalizumab’s established efficacy and safety profile while offering significantly improved durability and reduced dosing frequency.”

In Part 2, participants receiving ozureprubart will continue treatment for another 24 weeks, while those on placebo will be re-randomized to active treatment every 8 or 12 weeks (with a loading dose at Week 26). All participants will undergo a DBPCFC at Week 48, followed by a 16-week safety monitoring period. The study is designed to provide key insights into ozureprubart’s potential as a novel, long-acting therapeutic approach for managing IgE-mediated food allergies.