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Septerna Announces Initiation of Phase 1 Clinical Trial of SEP-479, an Oral Small Molecule PTH1R Agonist for the Treatment of Hypoparathyroidism
Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-479 in Healthy Volunteers Data Anticipated in Late 2026 or
About this update from Septerna, Inc.
[{"type":"text","content":"Trial Designed to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SEP-479 in Healthy Volunteers Data Anticipated in Late 2026 or Early 2027 SOUTH SAN FRANCISCO, Calif., April 13, 2026 (GLOBE NEWSWIRE) -- Septerna, Inc. (Nasdaq: SEPN), a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) drug discovery, today announced the dosing of the first participants in its Phase 1 clinical trial of SEP-479, its potent oral small molecule 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-479 in healthy adult volunteers. “Hypoparathyroidism is a lifelong condition that patients must manage with either high doses of calcium supplements several times a day or daily parathyroid hormone (PTH) injections, both of which can place a substantial burden on patients over time,” said Jeffrey Finer, M.D., Ph.D., Chief Executive Officer and Co‑founder of Septerna. “We are encouraged by the preclinical data for SEP‑479, which underscore its potential to be a disease modifying therapy for hypoparathyroidism by directly targeting the PTH receptor to provide patients full‑day calcium control and relief from their debilitating symptoms. Based on these findings, we believe SEP‑479 has the potential to be differentiated as a once-daily oral therapy for patients, and we look forward to advancing our Phase 1 trial as rapidly as possible.” The randomized, placebo-controlled Phase 1 clinical trial is expected to enroll up to 150 healthy adult participants. Dosing is underway in the SAD portion of the clinical trial, which will evaluate the safety and tolerability of SEP-479 at escalating oral doses. The MAD portion of the clinical trial is designed to evaluate the safety and tolerability of once-daily oral dosing of SEP-479 over multiple days of treatment, with secondary and exploratory endpoints including PK and PD, with the latter assessed by changes in endogenous PTH and serum calcium, as well as other biomarkers. Septerna anticipates reporting data from the trial in late 2026 or early 2027. About SEP-479Septerna is developing SEP-479, a potent oral small mole...