Septerna doses first participants in Phase 1 trial of SEP-631 for mast cell-driven diseases

Septerna, Inc.

SEP-631 is an oral small molecule MRGPRX2 negative allosteric modulator (NAM) targeting chronic spontaneous urticaria (CSU) and other mast cell-driven diseases.
Phase 1 SAD/MAD trial will evaluate safety, tolerability, PK and PD in up to ~150 healthy volunteers; SAD dosing is underway.
PD assessed via icatibant skin challenge in the MAD portion; no financial or guidance updates provided.
Septerna highlights unmet need in CSU where many patients do not respond to antihistamines.

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