Septerna (NASDAQ:SEPN) Announces Discontinuation of SEP-786 Phase 1 Clinical Trial

Septerna, a clinical-stage biotechnology company, recently made public its decision to halt the Phase 1 single- and multiple-ascending dose clinical trial of SEP-786, an oral small molecule agonist of the parathyroid hormone 1 receptor (PTH1R) aimed at treating hypoparathyroidism. The company decided to discontinue the trial following two unanticipated severe events of elevated unconjugated bilirubin in healthy volunteers participating in the trial. These events occurred without elevations in particular liver enzyme levels, and dosing was ceased for both individuals, with the bilirubin levels being reversible.

Jeffrey Finer, M.D., Ph.D., the President and Chief Executive Officer of Septerna, explained, “After careful evaluation of SEP-786 and in the context of our robust PTH1R agonist program, we’ve made the decision to discontinue the SEP-786 Phase 1 trial. We observed early signals of on-target pharmacological activity with SEP-786, with increases in serum calcium and corresponding decreases in endogenous PTH, reinforcing our commitment to developing an oral small molecule PTH1R agonist for hypoparathyroidism.”

In response to the unexpected trial outcome, and as part of its strategic plan, Septerna is moving ahead with various next-generation PTH1R agonists with distinct chemical structures in comparison to SEP-786. The company plans to select a next-generation candidate to accelerate towards clinical trials later this year to maintain momentum with its PTH1R program.

Furthermore, the company disclosed that SEP-786 had shown good tolerance in completed 28-day preclinical toxicology studies, indicating no anticipated risk of bilirubin elevation. Septerna has initiated non-clinical studies to investigate the underlying cause of the observed effect in the Phase 1 trial.

With regards to financials, as of September 30, 2024, Septerna’s cash, cash equivalents, and marketable securities totaled $137.5 million. Coupled with the net proceeds from the company’s IPO in October 2024 amounting to $302.6 million, Septerna foresees that its existing cash reserves will support planned operations at least until the latter half of 2027.

Septerna, Inc. operates as a pioneer in GPCR drug discovery, focusing on advancing numerous oral small molecule products for treating conditions in endocrinology, immunology and inflammation, and metabolic diseases, powered by its proprietary Native Complex Platform ™. For more information, visit www.septerna.com.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Septerna’s 8K filing here.

About Septerna

We are a clinical-stage biotechnology company pioneering a new era of G protein-coupled receptor (GPCR) oral small molecule drug discovery powered by our proprietary Native Complex Platform™. Our industrial-scale platform aims to unlock the full potential of GPCR therapies and has led to the discovery and development of our deep pipeline of product candidates focused initially on treating patients in three therapeutic areas: endocrinology, immunology and inflammation, and metabolic diseases.