2023-06-26 06:51:33 ET
Shares of Biomea Fusion ( NASDAQ: BMEA ) gained ~19% pre-market Monday as Wall Street reacted to the latest data from the company’s ongoing Phase 1/2 clinical study for lead asset BMF-219 in adults with uncontrolled type 2 diabetes.
12-week data from the Phase II portion of the trial named COVALENT-111 indicated that patients who received BMF-219 in Cohorts 2 and 3 had 0.1% and 1.0% declines in HbA1c, a human biomarker of high blood glucose, respectively.
In comparison, four adults on placebo indicated a mean HbA1c increase of 0.10%, while healthy volunteers in Cohort 1 achieved a -0.1%–0.1% change in HbA1c over 14 days under BMF-219 and during six weeks of follow-up.
According to the company, the experimental therapy was generally well tolerated during the four-week dosing period, and there were severe or serious treatment- emergent adverse events from Week 4–12.
Off-treatment, 70% of patients in Cohort 3 who were without food during the treatment period maintained or improved their time in range during continuous glucose monitoring, Biomea ( BMEA ) said.
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Biomea Fusion jumps 19% after Phase 2 data for diabetes therapy