Septerna eyes 2026 trial for new hypoparathyroidism treatment
Company now conducting preclinical tests to ID lead experimental therapy
Biotech company Septerna is currently conducting preclinical tests to identify a lead experimental therapy for hypoparathyroidism, with the hope of starting clinical trials in 2026.
“We are executing effectively across our portfolio, with each program nearing important milestones,” Jeffrey Finer, MD, PhD, CEO and co-founder of Septerna, said in a company press release. “Our next-generation PTH1R agonist program for hypoparathyroidism is progressing through preclinical studies as we work toward selecting a development candidate in the third quarter, with plans to start a Phase 1 clinical trial in the first half of 2026.”
Goal of potential hypoparathyroidism treatment is to normalize calcium levels
Hypoparathyroidism is a disorder caused by low levels of parathyroid hormone (PTH), a signaling molecule that helps to regulate levels of calcium in the body. Low PTH levels lead to low calcium levels, which can result in symptoms ranging from muscle cramps to seizures and reduced bone density. To manage the disorder, patients typically need to take calcium supplements to maintain levels in the normal range.
PTH exerts its effects on the body by binding to specialized protein receptors expressed on the surface of cells. PTH1R, short for parathyroid hormone 1 receptor, is one of the receptors for PTH. Septerna is currently working to develop next-generation PTH1R agonists — oral small molecules able to activate the receptor, effectively mimicking the activity of naturally occurring PTH.
The hope is to normalize calcium levels to reduce or eliminate the need for supplements.
We believe we are well positioned to pursue multiple programs towards our goal of delivering innovative oral small molecule therapies that can meaningfully improve patient outcomes.
Septerna uses a therapy development platform focused on making detailed molecular models of receptor proteins like PTH1R in order to design drugs to efficiently target the receptors.
“We believe we are well positioned to pursue multiple programs [toward] our goal of delivering innovative oral small molecule therapies that can meaningfully improve patient outcomes,” Finer said.
Septerna said it is aiming to identify a PTH1R agonist candidate in the next month or two, and will provide an update when a lead candidate is selected. If all goes well with preclinical tests, Septerna said it is hoping to start Phase 1 studies of its potential hypoparathyroidism treatment in the first half of 2026.
The company didn’t go into details about the clinical study. Phase 1 studies are generally done in healthy volunteers to assess safety before Phase 2 and 3 trials are conducted to evaluate effectiveness.
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