Septerna to Present Phase 1 SEP-631 Data on March 1 at AAAAI Meeting
Septerna will present first-in-human Phase 1 proof-of-mechanism data for SEP-631, an oral MRGPRX2 negative allosteric modulator targeting chronic spontaneous urticaria at the AAAAI Annual Meeting on March 1 (Poster L58, 9:45–10:45 a.m. ET). SEP-631 uses short-wave infrared imaging in an icatibant skin challenge to assess target engagement.
1. Upcoming Presentation
Septerna will present data from its first-in-human Phase 1 proof-of-mechanism study of SEP-631 at the AAAAI Annual Meeting on March 1, 2026, in Philadelphia (Poster L58, 9:45–10:45 a.m. ET). This session marks the first public disclosure of human clinical data for the compound.
2. Trial Design and Imaging
The study utilizes short-wave infrared imaging in an icatibant skin challenge to quantify SEP-631’s ability to inhibit MRGPRX2-mediated mast cell activation. This mechanistic approach enables direct assessment of target engagement in patients with chronic spontaneous urticaria.
3. SEP-631 Development Pipeline
SEP-631 is a selective oral MRGPRX2 negative allosteric modulator designed to treat CSU and other mast cell-driven disorders. Preclinical models demonstrated potent inhibition of mast cell degranulation, supporting advancement into clinical trials.