Septerna, Inc. (SEPN) announced on Sunday, March 1 2026 that its oral MRGPRX2 negative allosteric modulator, SEP‑631, achieved robust, dose‑dependent inhibition of icatibant‑induced skin wheal formation in a randomized, double‑blind, placebo‑controlled Phase 1 trial in healthy volunteers. Complete inhibition was observed at doses as low as 10 mg once daily, and the drug was well‑tolerated across all dose levels with adverse events comparable to placebo.
The study also demonstrated a pharmacokinetic profile supportive of convenient once‑daily oral dosing, and the pharmacodynamic data confirmed target engagement of the MRGPRX2 pathway. Management noted that these results provide clinical proof‑of‑mechanism for the MRGPRX2 pathway and position SEP‑631 as a potentially differentiated oral treatment for patients with mast‑cell‑driven diseases such as chronic spontaneous urticaria.
Septerna plans to initiate a Phase 2b trial of SEP‑631 in chronic spontaneous urticaria in the second half of 2026, following completion of long‑term toxicology studies. The company also intends to pursue additional mast‑cell‑driven indications, including chronic inducible urticaria, atopic dermatitis, interstitial cystitis, migraine and asthma, as part of its broader pipeline strategy.
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