Clinical DevelopmentPositive Phase 1 results for SEP-631 demonstrated clear clinical proof of mechanism and supported advancement into a randomized, double-blind, placebo-controlled Phase 2b trial in chronic spontaneous urticaria.
Mechanism Of ActionSEP-631 locks the MRGPRX2 receptor with durable inhibition and slow dissociation, suggesting potential superiority as an oral inhibitor across multiple mast cell–driven diseases beyond chronic spontaneous urticaria.
Pipeline ExpansionSEP-479 completed investigational new drug enabling studies with supportive preclinical pharmacology and a projected human profile that supports once-daily oral dosing, while the TSHR program is progressing toward lead candidate selection to broaden the clinical pipeline.