Metsera, Inc. (NASDAQ: MTSR) has announced positive topline data from two phase 2b trials of their ultra-long acting GLP-1 RA candidate, met-097i, signaling a rapid transition into phase 3. The trials, Vesper-1 and Vesper-3, focused on evaluating the efficacy and tolerability of met-097i in participants with overweight or obesity without type 2 diabetes.
In Vesper-1, met-097i demonstrated a mean placebo-subtracted weight loss of up to 14.1% after 28 weekly doses, with a dose-dependent response. An exploratory analysis at the end of the weekly dosing phase of the study extension at 36 weeks highlighted substantial continued weight loss, indicating no plateau had been reached.
The tolerability profile of met-097i was also notable, with potentially class-leading tolerability observed in both trials. In Vesper-3, the trial arm that titrated from 0.4 mg to 0.8 mg to 1.2 mg over 12 weeks showed minimal diarrhea signal, with a risk difference from placebo of 13% for nausea and 11% for vomiting.
Importantly, the trials exhibited high participant retention, with Vesper-1 reporting only 2.9% total study discontinuation and Vesper-3 showing high participant retention to date.
These positive results have enabled Metsera to confirm phase 3 dosing regimens for met-097i, with the potential for monthly dosing and simplified titration, setting the stage for the initiation of a global phase 3 program in late 2025.
Additionally, Metsera is conducting ongoing phase 2b trials to further characterize the monthly profile of met-097i for long-term maintenance and in populations with type 2 diabetes mellitus. The company is also leveraging met-097i as the foundational incretin backbone for four additional clinical programs, including a monthly multi-nush combination, an ultra-long acting GIP receptor agonist, an oral form, and a prodrug designed for quarterly maintenance dosing.
Met-097i is being developed via the FDA biologic pathway with the intent to pursue regulatory approval in the United States under a BLA. This ultra-long acting GLP-1 RA is engineered for class-leading potency, durability, and combinability with other Metsera nush analogs, and is supported by the company's novel peptide stabilization and lipidation platform technology, Halo™.
These promising developments position Metsera as a clinical-stage biopharmaceutical company at the forefront of accelerating the next generation of medicines for obesity and metabolic diseases, with a broad portfolio of oral and injectable incretin, non-incretin, and combination therapies. Today the company's shares have moved 0.4% to a price of $52.31. For the full picture, make sure to review Metsera's 8-K report.
