Septerna announces results from Phase 1 trial of SEP-631

Septerna (SEPN) announced positive results from its Phase 1 clinical trial evaluating SEP-631, a potent and selective oral negative allosteric modulator, NAM, of Mas-related G protein-coupled receptor X2. Based on these results, Septerna plans to advance SEP-631 into Phase 2 development for chronic spontaneous urticaria, CSU, and continue evaluation of additional mast cell-driven indications. SEP-631 was well-tolerated across all doses studied: Adverse event profile comparable to placebo; No severe or serious adverse events; No clinically meaningful laboratory or ECG abnormalities. SEP-631 demonstrated a PK profile supportive of convenient once-daily oral dosing, including: Half-life of approximately 24 hours; No clinically meaningful effect of food on exposure, supporting dosing without food restrictions.