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BMEA News
BMEA Events
Biomea Fusion Completes Enrollment in COVALENT-211 Clinical Trial
Biomea Fusion announced the completion of enrollment in COVALENT-211, a randomized, double-blinded, placebo-controlled Phase II clinical trial evaluating icovamenib in patients with insulin-deficient T2D who remain inadequately controlled on standard-of-care antihyperglycemic therapies.
Biomea Fusion Begins New Phase of Research Study
Biomea Fusion announced that the first participant has been dosed in a new arm of the ongoing platform research study, Investigating and Optimizing Physical Function with Weight Loss: A Multi-Arm Open Label Adaptive Platform Trial. The study is being conducted in collaboration with the University of Leicester and is led by Professor Dame Melanie Davies and Professor Thomas Yates at the University of Leicester and Leicester Diabetes Centre and the NIHR Biomedical Research Centre Leicester.
Biomea Fusion Reports Progress in Q2 Clinical Trials
"The second quarter marked continued execution across our diabetes and obesity programs. We are near completion of enrollment in our COVALENT-211 Phase II clinical trial, continue to advance enrollment in COVALENT-212, and remain on track to report initial 28-day clinical weight reduction data from our BMF-650 Phase I clinical trial in the third quarter," said Mick Hitchcock, Interim Chief Executive Officer of Biomea Fusion. "The Type 1 diabetes data presented at the American Diabetes Association's Scientific Sessions strengthened our confidence in icovamenib's potential to preserve and improve endogenous insulin secretion, providing additional evidence that this program may have potential to address a significant unmet need. We are excited to advance the planned Phase II clinical trial in Type 1 diabetes patients and look forward to providing updates on this important program."
Biomea Fusion Partners with University of Leicester for Obesity Treatment Research
Biomea Fusion announced a research collaboration with the University of Leicester to evaluate its investigational menin inhibitor, icovamenib, in combination with semaglutide in obesity within the ongoing OPAL platform study. "We are excited to collaborate with Professor Davies, Professor Yates, and the team at the Leicester Diabetes Centre on this important addition to the OPAL platform study," said Thorsten Kirschberg, executive VP of research at Biomea Fusion. "Compelling preclinical data demonstrating synergistic effects between icovamenib and semaglutide gave us conviction that this combination has the potential to deliver meaningful benefits beyond weight loss alone." Enrollment is scheduled to begin in the third quarter of 2026, with the primary outcome assessment performed at week 24.
Biomea Cash Decreases to $45.1M, CEO Emphasizes Clinical Progress
As of March 31, the company had cash, cash equivalents and restricted cash of $45.1M vs. $56.2M at previous quarter end. "Across our portfolio, we continue to execute with focus and discipline, with all of our key clinical programs progressing on track toward important upcoming milestones, while maintaining a disciplined approach to managing our cash burn," said interim CEO Mick Hitchcock. "The recent 52-week data from the Phase II COVALENT-112 clinical trial in type 1 diabetes further support targeting menin as a novel approach across both type 1 and type 2 diabetes, which offers a paradigm shift and differs materially from existing therapeutic approaches. We are building on these findings with plans to initiate an investigator-sponsored Phase II clinical trial in collaboration with leading academic institutions specializing in T1D. We believe this collaboration, alongside the continued advancement of our type 2 diabetes and obesity programs, positions Biomea to deliver meaningful data across multiple indications in 2026."
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