Biomea Fusion Inc.’s new menin inhibitor is soon to begin clinical human trials after it restored glycemic control and outperformed the standard of care, in animal models.
Biomea Fusion Inc. (BMEA:NASDAQ) preclinical data show BMF-219 “could be a potential nonchronic treatment for type 2 diabetes,” reported Oppenheimer analyst Hartaj Singh in a June 8 research note.
“We are intrigued by the preclinical data and believe Biomea has the potential to conduct a fast-to-market strategy depending on appropriate Phase 1/2 data,” Singh wrote. “We remain bullish.”
The California-based biopharma plans to submit an investigational new drug application and initiate a Phase 1/2 clinical trial of BMF-219 in type 2 diabetes in late H2/22 or early H1/23, noted Singh.
Biomea Fusion is developing small molecule drugs to treat certain disorders. BMF-219, the company’s candidate for types 1 and 2 diabetes mellitus, inhibits menin function, thereby boosting beta cell numbers, Singh explained. This increases insulin production and counteracts high glucose levels.
Recent data from studies done on two types of rats, presented at the recent American Diabetes Association Scientific Sessions 2022, showed BMF-219 restored glycemic control, Singh reported. The drug candidate also outperformed pioglitazone, used as the standard of care, on tests of blood glucose levels. All subjects tolerated BMF-219 well.
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Having finished 90% of preclinical toxicity work, Biomea is about to begin clinical trials of BMF-219 in human subjects. The first will be a Phase ½ dose-escalation and dose-expansion study in healthy volunteers and type 2 diabetes patients.
Oppenheimer has an Outperform rating and a $22 per share price target on Biomea. Its current share price, in comparison, is around $8.58.
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