Metsera Unveils Encouraging Data from Phase 1 Trial of MET-233i
A remarkable placebo-subtracted mean weight loss of up to 8.4% was observed at Day 36,
showing promise for a once-monthly injection regimen.
The 19-day half-life positions MET-233i for innovative dosing options with the potential for a groundbreaking monthly GLP-1 + Amylin combination.
With a favorable safety profile, the company is excited to share its findings.
NEW YORK – Metsera, Inc. (Nasdaq: MTSR) has announced positive topline results from the Phase 1 clinical trial for MET-233i, an advanced amylin analog developed for exceptional durability and effectiveness. In this trial, MET-233i exhibited a significant mean placebo-subtracted weight loss of up to 8.4% by Day 36, indicating strong potential for once-a-month dosing options.
“These results are thrilling, showcasing MET-233i’s remarkable effectiveness without any safety concerns,” said Dr. Steve Marso, the Chief Medical Officer of Metsera. “Our findings reveal substantial weight loss comparable to current leading GLP-1 medications, positioning MET-233i as a potentially superior option for patients seeking effective weight management.”
The Phase 1 trial was a randomized, placebo-controlled study involving 80 participants with obesity, devoid of type 2 diabetes. Participants received single and multiple doses of MET-233i, ranging between 0.15 mg to 2.4 mg and showcased notable results.
Key Findings from the Phase 1 Trial
The topline highlights from the trial include:
- Outstanding pharmacokinetic profile: MET-233i demonstrated dose-linear pharmacokinetics with a half-life of 19 days. This profile stands out among existing amylin analogs, paving the way for simplified once-monthly dosing and integration with MET-097i, another promising candidate of Metsera.
- Significant weight loss: Participants achieved up to 8.4% mean placebo-subtracted weight loss, with some individuals reporting weight reductions as high as 10.2%. Post-dosing, individuals continued to show remarkable weight maintenance over four weeks, showcasing the drug's extended pharmacokinetic effects.
- Excellent tolerability: The tolerability profile was favorable; gastrointestinal symptoms noted during the trial were mild and primarily occurred in the initial week, suggesting a rapid build-up of tolerance.
- No adverse safety signals: Throughout the study, there were no severe adverse events reported, supporting a strong safety profile for MET-233i.
Professor Carel le Roux, a leader in metabolic research, commented, “The emergence of amylin agonists signifies a crucial advancement in metabolic treatments. The durability and effectiveness shown by MET-233i, along with its potential partnership with Metsera’s GLP-1 RA, may revolutionize conventional medication protocols by offering a once-a-month option for patients.”
Next Steps for MET-233i
Encouraged by these findings, Metsera is eagerly advancing MET-233i as both a standalone treatment and in combination with MET-097i in the following ways:
- An ongoing trial is testing weekly doses of MET-233i over 12 weeks, aiming for a tapered monthly administration in week 13, with preliminary data anticipated in the next phase.
- The company is also extending its ongoing study of MET-233i in conjunction with MET-097i, now targeting a twelve-week trial with results expected by the end of this year or early next year.
Metsera is excited to share that they also expect to unveil data from MET-034i, a GIP receptor agonist, in conjunction with MET-097i shortly.
Conference Call and Information Session
Today, Metsera is set to hold an information session discussing MET-233i’s Phase 1 trial outcomes. Interested parties can access the live webinar and replay on Metsera’s investor page.
Understanding MET-233i
MET-233i is a subcutaneous injectable amylin analog designed for long-lasting effects and combined use with GLP-1 receptor agonists like MET-097i. Its promising effects are poised to offer new treatment options for managing weight effectively.
Exploring Metsera's HALO™ Platform
Metsera is proud to introduce its HALO™ technology, which maximizes drug effectiveness by enhancing the binding of peptides to target proteins while significantly extending their half-life. This innovation could lead to improved patient experiences through less frequent dosing and better overall tolerability.
A look at Metsera, Inc.
Founded in 2022, Metsera is a pioneering biopharmaceutical company dedicated to revolutionizing treatment options for obesity and metabolic disorders. With a robust portfolio of innovative therapies, Metsera aims to set new benchmarks in weight management and continues to develop medicines with the potential for significant impact in the healthcare landscape.
Frequently Asked Questions
What are the key findings from the Phase 1 trial of MET-233i?
The trial indicated a significant mean placebo-subtracted weight loss of up to 8.4% and displayed a favorable safety profile without severe adverse events.
How does MET-233i work?
MET-233i is an injectable amylin analog that aims to enhance weight loss while being combined effectively with GLP-1 receptor agonists.
What does the HALO™ technology offer?
HALO™ technology enhances the pharmacokinetics of peptides, allowing for longer-lasting effects and improved dosing schedules for patients.
When can we expect more data or updates on MET-233i?
Preliminary results from ongoing studies are expected soon, with further results anticipated by late this year or early next year.
Where can I find more information about Metsera?
Information about Metsera and its work can be found on their official website and through their investor relations sections.
