Biomae Fusion has completed patient enrolment in its phase II trial of icovamenib, a potential breakthrough in insulin-deficient type 2 diabetes, with results now expected in early 2027, signalling a significant step forward for the experimental drug.
Biomae Fusion said it has finished enrolling patients in a phase II trial of icovamenib in insulin-deficient type 2 diabetes, moving the experimental drug a step closer to its next read-out. The California-based company said the study, known as COVALENT-211, has recruited 64 participants across 18 sites and is testing the once-daily pill as an add-on to existing treatment in people whose blood sugar remains above target.
According to the company, patients are split 2:1 between icovamenib and placebo, with treatment lasting 12 weeks before a longer follow-up period aimed at assessing whether any effect on glucose control and beta-cell function lasts. Biomae Fusion said the main endpoint will be measured at week 26 and that topline data are now expected in the first quarter of 2027.
The update comes after earlier internal results from the COVALENT-111 study suggested icovamenib could produce durable reductions in HbA1c, a measure of blood sugar over time, in certain type 2 diabetes groups. The company has also been advancing a separate phase II trial, COVALENT-212, in patients not meeting targets on GLP-1-based therapy, with that study still enrolling and results expected in the second quarter of 2027. Biomae Fusion had previously said both programmes were designed around patient groups that appeared to respond best in earlier testing, but the latest timetable points to a longer wait for a fuller read-out than the company had indicated earlier this year.
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