Septerna reports positive Phase 1 data for oral MRGPRX2 NAM SEP-631, plans Phase 2 in chronic spontaneous urticaria

Septerna, Inc.

SEP-631 well-tolerated; adverse event profile comparable to placebo across all doses studied
Complete inhibition of icatibant-induced skin wheal formation at doses as low as 10 mg once daily
Pharmacokinetic profile supports once-daily dosing with approximately 24-hour half-life
Company plans Phase 2b trial in chronic spontaneous urticaria in the second half of 2026

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