Septerna, Inc.
For the period ended Mar 1, 2026. Filed Mar 2, 2026.
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Mar 1, 2026 · Filed Mar 2, 2026
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Phase 2 Development Strategy
The Company also announced its plans to initiate a Phase 2b clinical trial of SEP-631 in chronic spontaneous urticaria (“CSU”) in the second half of this year, following the completion of ongoing long-term toxicology studies.
The planned Phase 2b study will be a randomized, double-blind, placebo-controlled, global trial evaluating once-daily oral SEP-631 in adult patients with moderate-to-severe CSU who remain symptomatic despite treatment with second-generation antihistamines. Following the CSU study initiation, the Company also plans to pursue an open-label study in chronic inducible urticaria, specifically in patients with symptomatic dermatographism.
Beyond urticaria, the Company is evaluating additional mast cell-driven diseases with high unmet medical need and evidence of MRGPRX2 expression, and has initially prioritized atopic dermatitis, interstitial cystitis, migraine and asthma for further assessment.
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