Septerna to present Phase 1 clinical trial data for SEP-631

Septerna, Inc. announced that data from its Phase 1 clinical trial of SEP-631 will be presented at the 2026 American Academy of Allergy Asthma & Immunology (AAAAI) Annual Meeting. The conference is scheduled to take place in Philadelphia from February 27 to March 2, 2026.

SEP-631 is an oral small molecule and a negative allosteric modulator (NAM) of the Mas-related G protein-coupled receptor X2 (MRGPRX2). It is being developed for the treatment of chronic spontaneous urticaria (CSU) and other diseases driven by mast cell activation. The company aims to address significant unmet medical needs with this therapy candidate.

The company's data will be featured in a poster presentation session on March 1, 2026. The presentation will detail the first-in-human, proof-of-mechanism study, which uses short-wave infrared imaging to assess response to an icatibant skin challenge to evaluate the drug's effect on mast cell degranulation.

Septerna is a clinical-stage biotechnology company focused on advancing G protein-coupled receptor (GPCR) therapies. Their proprietary Native Complex Platform™ is designed to enable novel approaches to GPCR drug discovery, leading to a pipeline of oral small molecule drug candidates for various therapeutic areas.