RAPT Therapeutics Receives FDA Clearance to Initiate Phase 2b Trial of RPT904 for Food Allergy

RAPT Therapeutics Receives FDA Clearance to Initiate Phase 2b Trial of RPT904 for Food Allergy

By, Admin 1 October 2025

RAPT Therapeutics, Inc. (NASDAQ: RAPT), a clinical-stage immunology-based biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to advance RPT904 into a Phase 2b clinical trial for the treatment of food allergy.

The upcoming study, named “prestIgE”, will be a randomized, double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of RPT904 dosed every 8 weeks (Q8W) and every 12 weeks (Q12W).

Study Design – The “prestIgE” Trial

  • Participants: ~100 patients with at least one IgE-mediated food allergy (peanut, milk, egg, walnut, or cashew).
  • Structure: Two-part, multi-center study.
  • Treatment arms: RPT904 Q8W, RPT904 Q12W (with loading dose), or placebo in a 2:2:1 ratio.
  • Part 1 (Weeks 0–24): Assess primary endpoint – proportion of participants reaching a prespecified target threshold at a double-blind, placebo-controlled oral food challenge (DBPCFC) at Week 24.
  • Part 2 (Weeks 25–48): Placebo patients re-randomized 1:1 to RPT904 Q8W or Q12W; DBPCFC at Week 48.
  • Follow-up: 16-week safety observation after completion of dosing.

Executive Commentary

  • Brian Wong, M.D., Ph.D., President & CEO, RAPT Therapeutics:
    “Clearance of our IND application, which included data from our Chinese partner Jeyou, is an important and meaningful step. RPT904 is a next-generation, half-life extended anti-IgE molecule with a differentiated profile. We are excited to initiate the Phase 2b study by year-end as we work toward a best-in-class therapeutic for the underserved food allergy community.”

Dr. Wong also highlighted the company’s expectation of clinical data from Jeyou’s ongoing Phase 2 trials in chronic spontaneous urticaria and asthma by the end of 2025.

About RPT904

  • Class: Next-generation, half-life extended anti-IgE bio-better monoclonal antibody (mAb).
  • Target: Same epitope as omalizumab (first-generation anti-IgE mAb).
  • Mechanism: Inhibits free and cell-bound IgE, a key driver of allergic diseases.
  • Differentiation: Early studies show extended pharmacokinetics (PK) and pharmacodynamic (PD) properties compared to omalizumab.
  • Indications under development: Food allergy, chronic spontaneous urticaria, and other allergic inflammatory diseases.

About RAPT Therapeutics

RAPT Therapeutics, Inc. (NASDAQ: RAPT) is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel therapies for inflammatory and immunological diseases. Its pipeline is built on deep expertise in immune regulation and targeted biologics

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