Core Insights - Septerna, Inc. announced positive results from its Phase 1 clinical trial of SEP-631, a selective oral negative allosteric modulator targeting MRGPRX2, demonstrating robust inhibition of icatibant-induced skin wheal formation and well-tolerated across all doses studied [1][2][3] Phase 1 Results - SEP-631 was evaluated in a randomized, double-blind, placebo-controlled Phase 1 trial, showing a favorable pharmacokinetic profile supportive of once-daily oral dosing [3][5] - Complete inhibition of skin wheal formation was observed at doses as low as 10 mg once daily, with dose-dependent inhibition noted at higher doses [3][5] - The adverse event profile was comparable to placebo, with no severe or serious adverse events reported [5] Phase 2 Development Strategy - The company plans to initiate a Phase 2b clinical trial of SEP-631 in chronic spontaneous urticaria (CSU) in the second half of 2026, following ongoing long-term toxicology studies [4][6] - The Phase 2b study will be a randomized, double-blind, placebo-controlled trial evaluating once-daily oral SEP-631 in adult patients with moderate-to-severe CSU [6] Future Indications - Beyond CSU, Septerna is exploring additional mast cell-driven diseases with high unmet medical need, including atopic dermatitis, interstitial cystitis, migraine, and asthma [7][9] Company Overview - Septerna, Inc. is a clinical-stage biotechnology company focused on GPCR-targeted medicines, utilizing its proprietary Native Complex Platform for drug discovery [10]
Septerna Announces Positive Phase 1 Data for SEP-631, an Oral MRGPRX2 NAM for the Treatment of Mast Cell-Driven Diseases, and Outlines Initial Phase 2 Development Strategy