Septerna, Inc. announced the selection of SEP-204 as its development candidate for treating Graves' disease and thyroid eye disease (TED). The company reported positive preclinical data for the drug, a potent and selective oral small molecule, and plans to advance it into clinical trials.
Key Details
- Drug Candidate: SEP-204 is a potential first-in-class oral small molecule that acts as a thyroid-stimulating hormone receptor (TSHR) negative allosteric modulator (NAM).
- Clinical Timeline: The company plans to initiate a Phase 1 clinical trial in healthy volunteers in the first quarter of 2027.
- Preclinical Data: In animal models, SEP-204 restored normal thyroid hormone levels, reduced thyroid enlargement, and showed a favorable pharmacokinetic profile supporting potential once-daily oral dosing.