Results include 7.5% reduction in body weight from baseline at day 36
Weight loss continued to at least 4 weeks after last dose administered
MET-097, incorporating Metsera’s HALO™ platform technology, achieved 380-hour half-life
Potential for monthly dosing and dosing regimens without titration
Metsera launching Phase 2b trials in Q4 2024, with data anticipated in first half of 2025
NEW YORK--(BUSINESS WIRE)--Metsera, Inc., a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases, today announced positive topline results from the Phase 1 clinical trial of MET-097, an ultra long-acting injectable, fully-biased GLP-1 receptor agonist. In this study, MET-097 achieved significant and durable weight loss, supporting a potential once-monthly dosing regimen.
“We are excited about these positive results, which position MET-097 as an ultra-long acting, potent, yet well tolerated GLP-1 drug candidate,” said Steve Marso, M.D., chief medical officer of Metsera. “We are encouraged by both the safety profile and initial efficacy, in which MET-097 achieved weight loss matching, or potentially exceeding, currently available and investigational next-generation GLP-1 and GLP-1 combination drugs. Importantly, these data suggest the possibility for no titration and once monthly dosing, which may result in a more convenient, more scalable, and better tolerated way to administer GLP-1 medicines.”
The randomized, placebo-controlled, double-blind Phase 1 trial was designed to evaluate the tolerability, pharmacokinetics, pharmacodynamics and efficacy of subcutaneous MET-097 in 125 healthy, non-diabetic, overweight or obese adult participants. MET-097 was evaluated at single doses from 0.16 mg to 1.6 mg and weekly doses from 0.2 mg to 1.2 mg, given five times without titration.
Topline results from the Phase 1 trial include:
- Observed dose-linear pharmacokinetics with a half-life of 380 hours, consistent from subject-to-subject, based on the ultra-long clearance conferred by HALO™, Metsera’s proprietary, novel peptide lipidation platform technology. This translates to a 2-3 fold longer half-life than currently available and investigational nutrient-stimulated hormone (NuSH) products.
- Gastrointestinal adverse events were dose-related, mostly mild, and transient. Occurrence of these events was consistent with marketed and clinical-stage NuSH compounds. No severe treatment-related adverse events were observed, and there were no treatment-related study drug discontinuations.
- Change in body weight from baseline was dose-dependent, and at 1.2 mg was 7.5% at day 36 (one week after the final dose), consistent with or better than marketed and clinical-stage GLP-1 / GIP compounds.
- Cumulative weight loss at the 1.2mg dose was 8.1% at day 57, four weeks after the final dose, suggesting durable pharmacodynamic effect consistent with the observed 380 hour half-life.
“The Phase 1 data show that our proprietary HALO™ technology platform clearly confers ultra-long product half-life in people, validating the science underlying the Metsera discovery strategy. Based on these strong results, we believe we can produce a series of NuSH analogs with half-lives between 2-3-fold longer than the current marketed and investigational peptide NuSH analogs, and on par with antibody conjugated NuSH analogs,” said Brian Hubbard, Ph.D., chief scientific officer of Metsera.
Metsera plans to initiate a Phase 2b trial of MET-097 in Q4 2024, with data anticipated in the first half of 2025.
About Metsera
Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases. Metsera is advancing a broad portfolio of oral and injectable incretin, non-incretin and combination therapies with potential best-in-class profiles to address multiple therapeutic targets and meet the future needs of a rapidly evolving weight loss treatment landscape. Founded in 2022 by Population Health Partners and ARCH Venture Partners, Metsera has raised $322 million in financing from leading healthcare investors and is based in New York City. For more information, please visit us at www.metsera.com and follow us on LinkedIn.
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