Septerna, Inc. (SEPN), a clinical-stage biotechnology company, announced on Tuesday its decision to discontinue the Phase 1 clinical trial of SEP-786, an oral small molecule agonist for hypoparathyroidism.
The decision follows the observation of two severe or Grade 3 events of elevated unconjugated bilirubin levels in the trial's multiple-ascending dose or MAD portion.
However, the bilirubin elevations were reversible, and no liver injury or serious adverse events were reported.
Despite early signs of on-target pharmacological activity, Septerna has decided to focus on advancing next-generation PTH1R agonists with distinct chemical structures.
Jeffrey Finer, CEO and co-founder of Septerna, expressed that the company remains committed to developing an oral small molecule PTH1R agonist for hypoparathyroidism, with plans to select a new candidate to progress into clinical trials later this year.
Septerna is also advancing SEP-631, an oral small molecule for mast cell diseases, with clinical initiation planned for later this year.
As of September 30, 2024, Septerna reported cash, cash equivalents, and marketable securities totaling $137.5 million.
Following its successful IPO in October 2024, the company expects its current cash position to support its operations through at least the second half of 2027.
Currently, SEPN is trading at $4.65 down by 64.37%.
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