RAPT Therapeutics Advances RPT904 Into Phase 2b Trial For Food Allergies

RAPT Therapeutics, Inc. has received FDA clearance to advance its investigational drug RPT904 into a Phase 2b clinical trial for patients with food allergies. The trial, called prestIgE, will test the safety and efficacy of RPT904 administered subcutaneously every eight weeks (Q8W) or twelve weeks (Q12W) compared to placebo.

The prestIgE trial is a two-part, randomized, double-blind, placebo-controlled study involving about 100 participants with IgE-mediated food allergies, such as peanut, milk, egg, walnut, or cashew. In the first 24-week phase, patients will receive either RPT904 or placebo, with the primary endpoint being the proportion of participants reaching a target threshold at a double-blind, placebo-controlled oral food challenge (DBPCFC). In the second part, participants initially on placebo will be re-randomized to receive RPT904, extending treatment to 48 weeks, followed by a 16-week safety observation period.

“Clearance of our IND application, which included data from our Chinese partner Jeyou, is an important and meaningful step for the program,” said Brian Wong, M.D., PhD, President and CEO of RAPT. “We are excited to advance clinical development of RPT904, our next-generation, half-life extended anti-IgE molecule with a differentiated product profile. We are on track to initiate our Phase 2b clinical trial by the end of the year, taking us closer to our objective of delivering a best-in-class therapeutic option to patients in the large and underserved food allergy community. Furthermore, we look forward to data from Jeyou’s Phase 2 trials in chronic spontaneous urticaria and asthma, which we also expect by the end of the year.”

RPT904 is a next-generation anti-IgE monoclonal antibody (mAb) designed to block free and cell-bound IgE, the key driver of allergic diseases. Compared to omalizumab, the first-generation anti-IgE therapy, RPT904 has shown extended pharmacokinetics and pharmacodynamics, supporting less frequent dosing. Beyond food allergies, the therapy is being developed for chronic spontaneous urticaria and other allergic inflammatory conditions.