US-based biotechnology company MBX Biosciences has dosed the first healthy patient in a Phase I/II clinical trial of MBX 1416 to treat post-bariatric hypoglycaemia (PBH).
The placebo-controlled, double-blind, randomised study is being carried out in the US.
It will assess the pharmacodynamics (PD), pharmacokinetics (PK), tolerability and safety of single and multiple ascending doses of the long-acting, glucagon-like peptide 1 (GLP-1) receptor antagonist MBX 1416 in healthy adults and patients with PBH.
Up to 56 participants aged 18 to 65 years will be enrolled and receive the dosages as a subcutaneous injection (SC).
Participants will receive a single dose of MBX 1416 or placebo in the first part of the study before being given repeat doses of MBX 1416 or placebo in the second part.
The study’s primary endpoints are evaluating the drug’s tolerability and safety while assessing PK and PD are its secondary endpoints.
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MBX Biosciences president and CEO Kent Hawryluk said: “We are pleased to advance our second innovative precision endocrine peptide candidate, MBX 1416, into the clinic with the initiation of the Phase I/II clinical trial.
“This milestone is an important step toward bringing a potential solution to patients with PBH, for which there are no currently approved therapies.
“We look forward to continuing enrolment, with topline results anticipated in the second half of 2024.”
Last month, MBX Biosciences reported positive results from the multiple ascending dose portion of a Phase I trial of its long-acting parathyroid hormone (PTH) peptide prodrug, MBX 2109.
The PD effects were consistent with the expected PTH pharmacology, while the PK parameters reflected the prodrug design and were supportive of once-weekly administration.
A total of 76 healthy adult subjects were enrolled in the trial, which was randomised, double-blind and placebo-controlled.
MBX Biosciences is due to release the full trial results at an upcoming medical conference.