Clinical-stage Metsera has emerged from stealth with $290 million in hand and the bold vision of ushering in the next generation of obesity and metabolic disease medicines.
“It's an almost limitless market opportunity,” Metsera CEO Clive Meanwell, M.D., told Fierce Biotech in an interview. The leader is a British oncologist with an extensive industry track record that includes founding and leading The Medicines Company, a biotech that homed cardiovascular medicine inclisiran (Leqvio) and was acquired by Novartis in 2019 for $9.7 billion. “I think we have a real shot here of making some major products.”
Meanwell also helped form and is a partner of private equity firm Population Health Partners. The firm, alongside Arch Venture Partners, launched Metsera during biotech’s “nuclear winter” in early 2022, the CEO explained.
However, the company was able to stay warm in stealth with the help of several other investors such as F-Prime Capital, GV, Mubadala Capital, Newpath Partners and SoftBank Vision Fund 2, alongside other undisclosed investors.
The $290 million financing was led by founder Arch and is a series A round that includes a “little seed” money, according to Meanwell.
“There was emerging evidence that diabetes and weight loss was going to become a big category,” he said, explaining how Metsera came to be.
“Initially, we had discussions with Big Pharma about their appetite for investing—I'd say in 2020, it was sort of lukewarm,” Meanwell said. “Nobody had quite seen the juggernaut that was coming.”
After Eli Lilly and Novo Nordisk started publishing “great data” for the diabetes and obesity franchises-in-a-drug semaglutide and tirzepatide, respectively, Meanwell and the Arch crew decided to abandon the Big Pharma aspirations and start something of their own.
“We went out and said, let's go shopping among the 200-plus companies that are already working in this space, and let's see if we can pick up some great technology and create a new company that could develop these technologies for commercial use,’” he explained.
And that’s exactly what happened. While in stealth mode, New York-based Metsera snapped up Zihipp, a diabetes and obesity biotech in London. Researcher and Zihipp Chair Stephen R. Bloom now serves as the senior vice president of R&D for Metsera.
From Zihipp, Metsera picked up a proprietary library of more than 20,000 gut hormone peptides that can be mixed and matched “a bit like a Lego kit,” Meanwell described.
Then, Metsera hunted down oral absorption technology from an unnamed company that is designed to allow oral administration for injectable peptides.
“Metsera’s portfolio is designed to unlock new treatment strategies through scalable, sustainable and personalized interventions for weight loss, weight maintenance and disease prevention,” Metsera R&D lead Bloom—who is also the head of drug development, metabolism, digestion and reproduction at Imperial College London—said in an April 18 release. “Through optimized combinations of injectable and oral peptides, we aim to establish a cycle of continuous and responsive innovation to address a growing worldwide obesity crisis.”
Metsera’s injectable and oral development programs are made up of peptides and peptide-antibody conjugates, two of which are clinical-stage assets. One of those programs is an undisclosed molecule, while the other is an injectable, fully biased GLP-1 receptor agonist being assessed in a phase 1 clinical trial. The asset is designed to trounce competitors in duration of effect and is currently being tested out among non-diabetic patients. The U.S. trial is currently enrolling participants, Meanwell said.
The biotech’s preclinical pipeline also includes a dual amylin/calcitonin receptor agonist (DACRA) designed to be combined with the GLP-1 receptor agonist, a unimolecular GGG (GLP-1, GIP, glucagon) engineered for combo use with DACRA and two IND-ready candidates sourced from the company’s oral peptide delivery platform.
“The aim is to develop a suite of molecules that are miscible, or multi-target, molecules that give you the advantages of increased effect with less side effects,” Meanwell said. “We think the future is combinations, and we want to be there.”
“Most people would agree that a GLP-1 backbone or core is at the center of most people's strategies. And then the rest is: What do you add to that?” the leader continued. “Novo went down the amylin pathway successfully. Lilly went down the GIP glucagon pathway. And we think you should do both because, ultimately, those two pathways are coming together.”
Metsera’s programs are designed to address multiple therapeutic targets and tackle upcoming needs in the quickly evolving weight loss treatment landscape through more effective weight maintenance, muscle preservation, less frequent dosing and improved tolerability, according to the company release.
While Meanwell couldn’t disclose the specific size of Metsera’s team, he said “it’s not small.” He noted that a biotech of 70 people is an optimal size. Beyond R&D head Bloom, Metsara’s leaders include Brian Hubbard, Ph.D.; John Amatruda, M.D.; Whit Bernard; Christopher Cox; and Steven Marso, M.D., who is the principal author of two The New England Journal of Medicine papers that put semaglutide on the map.
“The ‘dream team’ terminology is overused, but in this case, between the investors—led by Arch—and the management, we’re as close as you can get to that definition, honestly,” Meanwell said.
As for other big-name company partners, Meanwell said Metsera hasn’t made any outreach efforts and doesn’t plan on it right now.
“In a way, we’re meeting Lilly and Novo at the corner—they themselves are very ambitiously seeking new combinations and new ways of improving risk benefit, ease of use, maintenance, dosing, tolerability,” Meanwell said. “And we're doing the same now. And we'd hope to be a player alongside them when we all get there.”