Septerna Announces Initiation of Phase 1 Clinical Trial with SEP-786, a Novel Oral Small Molecule PTH1R Agonist for the Treatment of Hypoparathyroidism

Trial Initiation Marks Septerna’s Transition to a Clinical-Stage Company Developing a Portfolio of Oral Small Molecule GPCR-Targeted Medicines

Phase 1 Clinical Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-786 in Healthy Volunteers

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Septerna, a clinical-stage biotechnology company pioneering a new era of GPCR-targeted drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-786, its novel, potent and selective, oral small molecule parathyroid hormone 1 receptor (PTH1R) agonist being developed for the treatment of patients with hypoparathyroidism. The Phase 1 clinical trial is a single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of SEP-786 in healthy adult volunteers.

Hypoparathyroidism is a debilitating endocrine disease caused by a deficiency of the parathyroid hormone (PTH) that results in a range of symptoms, including muscle cramps, fatigue, cognitive dysfunction, and life-threatening complications, such as cardiac arrhythmias, seizures, and renal failure. Conventional therapy requires patients take high doses of calcium and Vitamin D supplements orally several times daily or life-long daily injections of PTH replacement therapy.

“GPCR-targeted drugs have been the most productive target class in drug discovery history, with about one-third of all FDA-approved drugs targeting these receptors. Our proprietary Native Complex Platform™ fuels the discovery of oral small molecule compounds for a wide range of GPCRs, such as PTH1R, a validated receptor target for hypoparathyroidism,” said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co-founder of Septerna. “An oral small molecule PTH1R agonist has transformative potential as a convenient, disease-modifying treatment option that could provide patients with full-day calcium control, while resolving the serious effects of low blood calcium levels due to PTH deficiency. We look forward to assessing the safety of SEP-786 and its potential to normalize serum calcium levels, as we have seen in preclinical models, in this Phase 1 clinical trial.

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