Septerna Announces Selection of SEP-204 as Development Candidate for Graves' Disease and TED and Reports Preclinical Data at the 2026 American Thyroid Association Annual Meeting
Globe Newswire•04/11/2026•08:00 ET
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Key Highlights
- ➤SEP-204 selected as potential first-in-class Graves’ disease and TED candidate
- ➤Phase 1 healthy-volunteer trial planned for first quarter of 2027
- ➤Animal models restored normal T4 levels and reduced thyroid enlargement
- ➤Projected human half-life of approximately 20-40 hours supports once-daily dosing
- ➤SEP-204 generally well tolerated in 28-day rat and dog toxicology studies
Expert Statements
Rajiv Patni, Chief medical officer of Septerna
“Based on the pre-clinical data we have generated to date, we believe SEP-204 has the potential to change the treatment paradigm for Graves’ disease and TED, two serious autoimmune endocrine diseases that can profoundly affect patients’ health and quality of life.”
Rajiv Patni, Chief medical officer of Septerna
“We look forward to working closely with disease experts and the patient community to advance SEP-204 into clinical development and build upon these promising preclinical findings with clinical results.”
Potent, selective TSHR NAM with pre-clinical activity demonstrated across biochemical, thyroid and ocular endpoints
Favorable PK profile anticipated to support once-daily oral dosing in humans
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