RAPT Therapeutics Receives FDA Clearance to Begin Phase 2b Trial of RPT904 for Food Allergy
SAN DIEGO - August 7,2025 – RAPT Therapeutics inc. (RAPT) today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational new Drug (IND) request to initiate a Phase 2b clinical trial evaluating RPT904, an oral small molecule, in patients with food allergies.The trial will assess the safety and efficacy of RPT904 in desensitizing individuals to multiple common food allergens.
This IND clearance marks a meaningful advancement in the growth of a potential oral treatment for food allergies, a condition affecting an estimated 32 million Americans, including approximately 5.6 million children. Current management primarily relies on strict avoidance and emergency epinephrine,creating a substantial unmet need for more convenient and effective therapies. RPT904 aims to address this need by modulating the immune system to increase tolerance to allergenic foods. The Phase 2b trial will enroll patients with peanut, egg, and milk allergies, with initial results expected to provide critical data on the drugS potential to induce sustained desensitization.
RPT904 is a selective, oral, small molecule antagonist of the IL-4 receptor alpha subunit (IL-4Rα). By blocking IL-4 signaling, RPT904 is designed to modulate the immune response and promote tolerance to food allergens. The Phase 2b trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and preliminary efficacy of RPT904 in desensitizing patients to multiple common food allergens.
“We are pleased to have received IND clearance from the FDA and look forward to initiating our Phase 2b trial of RPT904,” said marian Navarrete, chief Executive Officer of RAPT Therapeutics.”This is a critical step forward in our mission to develop a transformative oral therapy for individuals living with the burden of food allergies.”
RAPT anticipates potential risks associated with the clinical development of RPT904, including uncertainties regarding efficacy or lead to regulatory approval, reliance on partners and third parties, clinical trial site activation or enrollment rates, and macroeconomic and geopolitical conditions. Detailed information regarding risk factors can be found in RAPT’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission (SEC) on August 7, 2025, and subsequent filings.
RAPT Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com
RAPT Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com
