Metsera’s Amylin drug looks good in Phase 1, showing obesity that may be once a month
An experimental Metsera obesity drug resulted in an average of 8.4% weight loss in a small clinical trial, with preliminary results keeping biotech competitive in a crowded portfolio of companies pursuing promising new metabolic targets, but may offer fewer doses than its competitors.
The drug Met-233i is a peptide designed to activate amyl protein, a hormone that plays a role in regulating blood sugar and appetite, like GLP-1. New York-based METSERA designed METSERA’s technology, which allows drugs to last longer in the body.
The 8.4% weight loss marker reported on Monday was achieved with a 1.2 mg dose, the highest dose of four doses taken for five weeks a week in the two-part Phase 1 study. 40 participants were recruited in each section. In the single dose portion of the study, a group of participants received only one dose, and the 1.2 mg dose resulted in an average weight loss of 3.8%, which lasted for five weeks.
Metsera said its drug supports its 19-day half-life once a month. This will be the one-time dose of currently available GLP-1 drugs, as well as the advantages that other companies are developing clinical-stage link drugs such as Novo Nordisk, Roche and Abbvie are developing.
Gastrointestinal side effects (such as nausea and diarrhea) are common for metabolic drugs targeting gut receptors for obesity. Metsera said these adverse reactions were classified as mild and dose-dependent in their Phase 1 study. The company added that these effects are limited to the first week of dosing, which suggests a rapid start of tolerability.
Metsera expects patients to start escalating to full doses at lower doses. At these lower doses, the first phase results showed that Met-233i had a similar side effects as placebo. This dose titration method is part of an ongoing Phase 1 monotherapy study that is evaluating 12 doses of MET-233I and then exposes matched monthly doses at week 13.
“We observed five weeks of weight loss comparable to the leading GLP-1 drug, and we determined effective starting doses with placebo-like tolerance,” Metserra Chief Medical Officer Steve Marso said in a prepared statement. “These data locations MET-233I are potentially first-class amyloids and support category-leading profiles in combination with Met-097i.”
The ability of Metsera drugs to achieve longer dosing comes from a platform technology called lipid optimization or half-life optimization of halo. This technology enables peptides to bind simultaneously its target and albumin, a protein found in the blood. Doing so can bring the half-life of the drug close to albumin. The half-life of this protein produced in the liver is about three weeks. Combination with it has been studied to improve the durability of shorter lifespans biopharmaceuticals.
Metsera also applies Halo to the GLP-1 drug Met-097i in its pipeline, which is currently in Phase 2 2B testing as a monotherapy. A 12-week phase 1 study assessed the combination of the drug with Metsera’s Amylin candidate. Preliminary data is expected to be by the end of this year or early 2026.
Another long-acting METSERA drug, Met-034i, is being developed to address GIP receptors to stimulate metabolic effects. The company is preparing to use the drug in combination with the GLP-1 drug candidate. Combining GLP-1 and GIP can allow Metsera to compete directly with Blockbuster Eli Lilly Drug Zepbound, but has the potential advantage of giving once a month with weekly injections of Lilly Drig. Metsera is expected to report preliminary data on its GLP-1 and GIP receptor-targeted drug combination by the end of 2025.
Metsera was founded in 2022 by Population Health Partners and Arch Venture Partners. In February, the clinical-stage company raised $275 million in one of the few biotech IPOs this year, at a price of $18 per share. Metsera opened at $31.60 on Monday, up nearly 15% from Friday’s closing price.
Photo: Peter Dazeley, Getty Images
