Biomea Fusion has shared phase 1 data on its oral GLP-1 prospect, shedding light on a small molecule designed to balance efficacy and gastrointestinal tolerability. Management hailed the data as a launchpad for talks with potential partners, but investors drove down the share price of the cash-strapped biotech.
Like Eli Lilly’s Foundayo, Biomea’s BMF-650 is an oral small molecule GLP-1 receptor agonist. Biomea ceded a big head start to Foundayo, which received FDA approval in April, but the biotech sees an unmet need for a drug that separates gastrointestinal side effects from weight loss.
Biomea posted phase 1 data on BMF-650 after the market closed Tuesday, linking the drug candidate to mean weight reductions of 1.5% to 3.2% across four cohorts at Day 29. Participants in a fifth cohort, who were treated under confinement, lost 6.1% of their weight by Day 29. However, the two placebo patients in the cohort experienced similar weight loss after consuming about one-third of the presented food.
The weight loss data are unremarkable in a competitive field. However, in Biomea’s take, the moderate weight loss is a feature, not a bug, as chief operating officer Ramses Erdtmann explained on a call with investors to discuss the data.
“Our goal was not to achieve maximum weight loss. Our goal was to achieve a good weight loss over time,” Erdtmann said. “You can step into this compound from another drug; you don't have to up-titrate. You can easily just switch if you're unhappy with what you're currently on.”
“Those kinds of aspects, I think, could potentially add value,” the COO suggested.
This didn't seem to be enough to appease investors, who sent the company's stock down 30% to 87 cents in the opening hour of trading Wednesday from a Tuesday closing price of $1.26.
BMF-650 can compete if it drives about 10% weight loss in longer trials, Biomea’s chief medical officer Juan Frías, M.D., said on the call. The prediction assumes BMF-650 delivers such weight loss while having a relatively benign gastrointestinal tolerability profile.
Across the 40 patients in the five cohorts, the rates of nausea, constipation, vomiting and diarrhea were 17.5%, 10%, 7.5% and 5%, respectively. Biomea compared its data favorably to results on other oral GLP-1 drugs, presenting (PDF) a slide showing the rates of most gastrointestinal adverse events were among the lowest in the class.
While Biomea talked up the data, the company plans to limit its future investments in the asset. Rather than take the candidate forward itself, the biotech plans to run longer-term toxicology studies and carry out other work to maximize the molecule’s value while seeking a partner for further development.
“What we're thinking of doing is initiating ... cohort 6, potentially with a partner, where we would go in, add another, whatever, 10, 15, 20 patients with a larger placebo setting, not in a confinement situation, and run that cohort,” Erdtmann said. “That would more or less clarify the signals we have seen and allow somebody else, very likely, to take this drug into phase 2.”
Biomea’s reluctance to invest the large sums needed to develop an obesity drug reflects the company’s financial situation. The biotech ended June with $35.2 million, a sum it predicted would fund operations into the second quarter of 2027.
Biomea tried to raise money in September, only to abandon the offering in response to “current market conditions.”
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