RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy
Shots:
- The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025
- The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food allergy will be treated for 24wks., while in Part 2 all pts will receive RPT904 for another 24wks. with DBPCFC at Wk. 48, followed by a 16wk. safety follow-up
- RPT904 is a novel, half-life–extended anti-IgE mAb targeting the same epitope as omalizumab, designed to inhibit free & cell-bound IgE for treating food allergies, chronic spontaneous urticaria, & other allergic inflammatory diseases
Ref: RAPT Therapeutics | Image: RAPT Therapeutics | Press Release
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