RAPT Therapeutics Receives FDA Clearance to Beginโ Phase 2b Trial of RPT904 for Food Allergy
SAN DIEGO โค- August 7,2025 – RAPT Therapeutics inc. (RAPT) todayโฃ announcedโ theโ U.S. Foodโข andโค Drug Administration (FDA) has โcleared its Investigational new Drug (IND) request to initiate a Phase 2b clinical trial evaluating RPT904, an oral small โขmolecule, โคin patients with food allergies.The trial will assess the safety and efficacy of RPT904 inโค desensitizing individuals to multiple commonโ foodโฃ allergens.
This IND clearanceโข marksโ a โmeaningful advancement in the growth ofโ aโ potential โoral treatment for food allergies, a condition โคaffecting anโ 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 โฃconvenient and effectiveโ therapies. RPT904 aims to address this need by โขmodulatingโ the immuneโ system to increase tolerance to allergenicโ foods. Theโ Phase 2b โtrialโ will enroll โขpatients with peanut, egg, andโ milk allergies, with initial results expected to provide criticalโฃ data on the drugS โpotentialโค to induce sustained desensitization.
RPT904 isโ a selective, oral, small molecule antagonist of โthe IL-4 receptor โalphaโ subunitโ (IL-4Rฮฑ). By blocking IL-4 signaling,โ RPT904 is designed to โฃmodulate the immune response and promote โขtolerance to food allergens.โ The Phase 2b โฃtrial is a randomized, double-blind,โฃ placebo-controlled study designed to evaluate the โsafety, tolerability, and preliminaryโข efficacy of RPT904โ in desensitizing patients to multiple common food allergens.
“We are pleased toโค have received INDโ clearanceโ from the โFDA โand look forward to initiating our Phaseโ 2b trialโฃ of RPT904,” said marian Navarrete, chief Executive Officer of RAPTโ Therapeutics.”This is a critical step โฃforward in our mission to developโ a transformative oral therapyโ forโ individuals living with the burden โof food allergies.”
RAPT anticipates potential risks associated with the clinical development โคof โขRPT904, including uncertainties โregardingโ efficacy โor lead to regulatory approval, reliance on partners and third โคparties, clinical trial site activation orโ enrollment rates,โ and macroeconomic and geopolitical conditions. Detailed informationโ regarding risk factors can be found in RAPT’s Quarterly โReport on Form 10-Q for the quarter ended June โฃ30,โค 2025, filedโฃ with the Securities and Exchange Commission (SEC) โon โฃAugust 7, 2025,โ and subsequent filings.
RAPT Investor Contact:
Sylviaโ Wheeler
swheeler@wheelhouselsa.com
RAPT Media Contact:
Aljanae Reynolds
areynolds@wheelhouselsa.com