The Phase II Avail trial is assessing MBX 2109 as a potential treatment for chronic hypoparathyroidism. Credit: Pixel-Shot / Shutterstock.

US-based biotechnology company MBX Biosciences has dosed the first subject in a Phase II trial of MBX 2109, a potential treatment for chronic hypoparathyroidism (HP).

The Avail trial is being carried out as a randomised, double-blind, placebo-controlled study that has enrolled 48 adult HP patients.

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It aims to assess the safety, tolerability and efficacy of MBX 2109 over 12 weeks.

Determining the percentage of patients who can stop using active vitamin D and lower their calcium supplement intake to 600mg or less per day while maintaining normal serum calcium levels will be the study’s primary endpoint.

Secondary objectives include evaluating the drug’s safety, tolerability, pharmacokinetics and pharmacodynamics and measuring its impact on quality of life through patient-reported outcomes.

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Participants in the Avail trial are being randomly assigned to receive weekly subcutaneous injections of placebo or MBX 2109 at doses of 400μg, 600μg or 800μg.

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The 12-week treatment consists of a four-week fixed-dose phase followed by an eight-week titration phase.

During the titration phase, patients who do not meet the discontinuation or calcium reduction criteria can adjust their dose based on a predefined protocol.

Subjects who complete the 12 weeks of treatment can then join a 104-week extension study, in which all patients will receive MBX 2109.

MBX Biosciences president and CEO Kent Hawryluk said: “We are pleased to advance our innovative precision endocrine peptide candidate, MBX 2109, by dosing our first patient with HP.

“The Phase I findings for safety, pharmacokinetics and pharmacodynamics support the potential of MBX 2109 as the first once-weekly parathyroid hormone (PTH) prodrug for HP, and initiation of patient dosing brings us closer to launching our potential PTH therapy.

“We look forward to continued enrolment and dosing of patients, with topline results anticipated in the third quarter of 2025.”