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
