On October 27, 2025, RAPT Therapeutics, Inc. (Nasdaq: RAPT) announced that it has begun the prestIgE Phase 2b clinical trial of ozureprubart (formerly RPT904) in patients with IgE‑mediated food allergy. The press release, issued from South San Francisco, California, states that the randomized, double‑blind, placebo‑controlled study will enroll approximately 30 sites across the United States, Canada and Australia.
The trial is designed as a two‑part study. In Part 1, about 100 participants with at least one food allergy (peanut, milk, egg, walnut or cashew) will receive ozureprubart subcutaneously every 8 weeks or every 12 weeks, each arm including a loading dose at week 2, versus placebo in a 2:2:1 randomization. The primary endpoint is the proportion of participants who achieve a prespecified threshold on a double‑blind, placebo‑controlled oral food challenge (DBPCFC) at week 24. In Part 2, participants in the ozureprubart arms will continue treatment for an additional 24 weeks, while placebo recipients will be re‑randomized to receive ozureprubart every 8 weeks or 12 weeks (with a loading dose at week 26) through week 48, with a final DBPCFC at week 48 and a 16‑week safety follow‑up.
This initiation marks a significant operational milestone for RAPT, moving its lead anti‑IgE antibody from preclinical and Phase 1 studies into a pivotal Phase 2b trial focused on food allergy. Ozureprubart is a half‑life extended, bio‑better monoclonal antibody that targets the same epitope as omalizumab but offers improved durability and reduced dosing frequency. Successful outcomes in this trial could position RAPT to capture a substantial share of the growing food‑allergy market and accelerate the commercial potential of its flagship asset.
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