On September 29, 2025, RAPT Therapeutics announced that the U.S. Food and Drug Administration cleared its Investigational New Drug application to proceed to a Phase 2b clinical trial of RPT904 for the treatment of patients with food allergy. The clearance allows the company to move forward with the study, marking a significant regulatory milestone for its lead anti‑IgE antibody.
The Phase 2b trial, named “prestIgE,” will enroll approximately 100 participants with IgE‑mediated food allergy. It will compare two dosing regimens—subcutaneous administration every 8 weeks and every 12 weeks—to placebo in a randomized, double‑blind, placebo‑controlled design. The primary endpoint is the proportion of participants who achieve a predefined target threshold at a double‑blind, placebo‑controlled oral food challenge at week 24.
The FDA clearance is a critical step for RAPT’s RPT904 program, which has demonstrated extended pharmacokinetics and deeper IgE reduction in early studies. The upcoming trial will generate pivotal safety and efficacy data that could support future regulatory submissions and potential commercialization in the large and underserved food allergy market.
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