Biomea Fusion said on Monday that its experimental drug, icovamenib, showed sustained blood sugar control in patients with type 2 diabetes and may benefit those not responding to GLP-1 therapies such as Novo Nordisk’s Ozempic.
According to the company, blood sugar levels remained lower nine months after discontinuing treatment with icovamenib, indicating it might help restore the cells that produce insulin.
In a year-long mid-stage study, Biomea Fusion stated that patients with type 2 diabetes who were not responding to Novo Nordisk’s Ozempic showed noticeable improvement after 12 weeks of treatment with icovamenib.
The company reported that icovamenib reduced blood sugar levels in such patients by an average of 1.3 per cent compared with those on placebo. The reduction in the overall study population was 1.8 per cent.
Icovamenib functions by partially blocking a protein known as menin, which may help restore natural insulin production in people with type 2 diabetes. Biomea Fusion said the drug performed particularly well in patients whose bodies do not make enough insulin, a group considered difficult to treat.
In 2024, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Biomea Fusion’s trials of icovamenib due to concerns about potential liver toxicity observed during the dose-escalation phase of the study. The hold was lifted three months later, in September 2024, after the company revised its study protocol to address safety concerns.
Biomea Fusion announced that it plans to begin two additional mid-stage studies in the fourth quarter of 2025 — one focusing on insulin-deficient patients and another targeting those not responding to GLP-1 therapies.
Following the announcement of a public offering, shares of Biomea Fusion reversed earlier gains and fell 5.2 per cent in choppy trading.