Septerna Announces Dosing Of First Participants In Phase 1 Clinical Trial Of SEP-631, Selective Oral Small Molecule MRGPRX2 NAM Being Developed For Treatment Of CSU And Other Mast Cell-Driven Diseases

Author: Benzinga Newsdesk | August 21, 2025 08:08am

Septerna, Inc. (NASDAQ:SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-631, a selective oral small molecule Mas-related G protein-coupled receptor X2 (MRGPRX2) negative allosteric modulator (NAM) being developed for the treatment of chronic spontaneous urticaria (CSU) and other mast cell-driven diseases. The Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SEP-631 in healthy adult volunteers.

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