Septerna Reports Positive Phase 1 Data for SEP-631 in Mast Cell-Driven Diseases

Reuters
03/01
Septerna Reports Positive Phase 1 Data for SEP-631 in Mast Cell-Driven Diseases

Septerna Inc. reported positive Phase 1 results from a randomized, double-blind, placebo-controlled trial of SEP-631, an oral negative allosteric modulator of MRGPRX2 being developed for mast cell-driven diseases. The company said SEP-631 was well tolerated with an adverse event profile comparable to placebo and showed dose-dependent inhibition of icatibant-induced skin wheal formation, including complete inhibition at doses as low as 10 mg once daily under a 10 µg/mL icatibant challenge. Septerna plans to initiate a global randomized, double-blind, placebo-controlled Phase 2b study in adults with moderate-to-severe chronic spontaneous urticaria in the second half of 2026, and later pursue an open-label study in chronic inducible urticaria (symptomatic dermatographism). The Phase 1 results and Phase 2 strategy will be presented on a company conference call and webcast scheduled for March 2, 2026.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Septerna Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202603010945PRIMZONEFULLFEED9663428) on March 01, 2026, and is solely responsible for the information contained therein.

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