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We are a clinical biopharmaceutical company developing MET-097i as an injectable treatment for obesity in a Phase I/Phase 2 clinical trial with overweight or obese healthy volunteers. (Incorporated in Delaware)
We are developing next-generation injectable and oral nutrient stimulated hormone, or NuSH, analog peptides to treat obesity, overweight and related conditions. Obesity and overweight are among the fastest-growing and most prevalent chronic human conditions, affecting approximately 2.5 billion people worldwide, and drive a broad range of severe diseases. Currently approved NuSH analog peptides are a promising treatment option for obesity and overweight. We use our proprietary MINT peptide library of NuSH analog peptides alongside our Half-life Augmentation by Lipid Optimization, or HALO, half-life extending platform and our MOMENTUM oral NuSH analog peptide delivery platform to deliver highly differentiated product candidates that we are advancing into clinical trials for obesity or overweight.
MET-097i, our most advanced product candidate, is a fully biased, monthly, subcutaneously injectable ultra-long acting GLP-1 RA that we are developing for the treatment of obesity and overweight. We have an ongoing Phase 1/2 clinical trial of MET-097i in the United States in participants who are obese or overweight but otherwise healthy. In September 2024, we announced preliminary results from Part A, the single ascending dose, or SAD, portion of the trial, and Part B, the multiple ascending dose, or MAD, portion of the trial, and in January 2025 we announced preliminary results from the Phase 2 (Part C) portion of the clinical trial. The preliminary data showed dose-linear pharmacokinetics, or PK, with a half-life of approximately 15 to 16 days. Mean placebo-adjusted body weight across the dose range in the Phase 2 part of the trial was 11.3% after twelve weekly doses of 1.2 mg and 7.2% after twelve weekly doses of 0.6 mg. In the MAD part of the trial, after five weekly doses of 1.2 mg, the mean change from baseline was 7.5% at day 36 (one week after the last dose), 8.1% at day 57 (four weeks after the last dose), and 7.5% at day 85 (eight weeks after the final dose), suggesting a durable pharmacodynamic, or PD, effect consistent with the observed half-life. Preliminary results of this clinical trial demonstrate that MET-097i was generally well-tolerated when dosed weekly as well as after a higher, potential monthly dose, with no treatment-related serious adverse events and no severe gastrointestinal adverse events.
We have initiated a 28-week, double-blind, placebo-controlled Phase 2b clinical trial of MET-097i assessing safety and efficacy at different weekly doses in participants with obesity or overweight without type 2 diabetes, or T2D, and we expect to report preliminary data from this trial in mid-2025. We plan to separately initiate a Phase 2b study in participants with obesity or overweight with T2D. If successful, we plan to initiate a Phase 3 clinical program shortly thereafter in the United States and various countries in Europe. We also plan to initiate a Phase 2b clinical trial that will evaluate the efficacy and tolerability of multiple monthly doses of MET-097i after multiple weekly doses, for which we expect to report preliminary results by year-end 2025 or in early 2026. MET-097i is classified as a biologic and we intend to pursue its regulatory approval in the United States pursuant to a biologics license application, or BLA.
Note: Net loss and no product revenue are for the 12 months that ended Sept. 30, 2024.
(Note: Metsera Inc. priced its IPO at $18.00 – $1.00 above the top of its $15.00-to-$17.00 price range – and cut the number of shares at pricing – to 15.28 million shares (15,277,778 shares) – to raise $275.0 million on Thursday night, Jan. 30, 2025.)
(Note: Metsera Inc. disclosed the terms for its IPO in an S-1/A filing on Monday, Jan. 27, 2025. The company is offering 17.19 million shares (17,187,500 shares) at a price range of $15.00 to $17.00 to raise $275.0 million. Background: Metsera filed its S-1 on Jan. 10, 2025, without disclosing its IPO’s terms; estimated IPO proceeds were $100.0 million. More Background: Metsera submitted confidential IPO documents to the SEC on Nov. 4, 2024.)
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