Hypoparathyroidism is a rare endocrine disorder characterised by insufficient PTH production. Credit: Pixel-Shot/Shutterstock.

Septerna has dosed the first subjects in a Phase I clinical trial of its investigational product SEP-786, being developed to treat hypoparathyroidism.

An oral small molecule, SEP-786 works by activating the parathyroid hormone 1 receptor (PTH1R).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

The trial is designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SEP-786 in up to 180 healthy adults.

The randomised, placebo-controlled trial will have single-ascending dose (SAD) and multiple-ascending dose (MAD) components.

Currently, subject dosing has commenced in the SAD part of the trial, which will explore the safety and tolerability of increasing oral doses of SEP-786.

The subsequent MAD portion will investigate the safety and tolerability of once-daily and twice-daily oral doses of the drug over several days.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Secondary endpoints of the study are PK, serum calcium changes, urinary calcium excretion, and other relevant biomarkers.

Hypoparathyroidism is a rare endocrine disorder characterised by insufficient PTH production, leading to low calcium levels and increased phosphorus levels in the blood.

Current treatments mainly involve calcium and vitamin D supplementation, which can be challenging to manage and do not address the underlying PTH deficiency.

Septerna CEO and co-founder Jeffrey Finer said: “An oral small molecule PTH1R agonist has transformative potential as a convenient, disease-modifying treatment option that could provide patients with full-day calcium control, while resolving the serious effects of low blood calcium levels due to PTH deficiency.

“We look forward to assessing the safety of SEP-786 and its potential to normalise serum calcium levels, as we have seen in preclinical models, in this Phase I clinical trial. I am very proud of the rapid execution by our R&D team in achieving this milestone, which underscores the power of our Native Complex Platform to take on GPCR targets which have been historically challenging for small molecule drug discovery.”