Core Insights - Septerna, Inc. has decided to discontinue the Phase 1 clinical trial of SEP-786 due to unanticipated severe events of elevated unconjugated bilirubin levels observed in participants [1][2][3] - The company is committed to advancing its PTH1R agonist program with multiple next-generation candidates that have distinct chemical structures [1][3] Group 1: Clinical Trial and Observations - The Phase 1 trial of SEP-786 was halted after two participants experienced Grade 3 elevations in unconjugated bilirubin, although no liver enzyme elevations were noted [2] - Dosing was stopped for the affected participants, and the bilirubin elevations were reversible, with no serious adverse events reported in the trial [2] Group 2: Future Plans and Financial Position - Septerna plans to select a next-generation PTH1R agonist candidate to accelerate clinical development later this year, despite the discontinuation of SEP-786 [3][4] - The company reported a cash position of 302.6 million in net proceeds from its IPO in October 2024, which is expected to support operations into at least the second half of 2027 [4]
Septerna Announces Discontinuation of SEP-786 Phase 1 Clinical Trial and Plans to Advance Next-Generation Oral Small Molecule PTH1R Agonist