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Shares of Biomea Fusion BMEA gained 9.1% on Thursday after the FDA lifted the clinical hold it had earlier placed on the company’s ongoing early to mid-stage studies evaluating its lead candidate, BMF-219, for treating type 2 and type 1 diabetes (T2D and T1D). The update follows a thorough review of the clinical data on the candidate, to date.
Biomea’s BMF-219 is an investigational novel covalent menin inhibitor that has been developed using the company’s proprietary FUSION System.
Recent Regulatory Updates Related to BMEA’s Diabetes Program
In June 2024, the FDA placed a full clinical hold on Biomea’s two phase I/II studies (COVALENT-111 and COVALENT-112) evaluating BMF-219 for T2D and T1D indications, respectively.
The action was taken after the regulatory body noted issues related to potential drug-induced liver toxicity observed during the completed Dose Escalation phase of COVALENT-111. Elevated liver enzymes were possibly influenced by higher doses (up to 400 mg) of BMF-219, food intake variations, medical history and concurrent medications during the studies.
However, Biomea clarified that the drug has been generally well tolerated in clinical studies, with most adverse events reported as mild to moderate in severity. Additionally, to date, no serious adverse reactions have been identified with BMF-219 in either COVALENT-111 or COVALENT-112. Management believes that the candidate holds the potential to restore glucose-controlled insulin production and improve glycemic control in diabetes patients.
Year to date, shares of BMEA have plunged 34.1% compared with the industry’s 3.5% decline.
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In the latest press release, Biomea reported that the FDA’s safety review of the ongoing phase IIb expansion portion of the COVALENT-111 study of BMF-219 showed that the concerning safety signals observed in the phase IIa escalation portion of the study did not carry over. Importantly, none of the elevated lab values resulted in confirmed serious liver injury or impairment.
Having received the green light from the FDA, the company has now fully resumed its T2D and T1D studies of BMF-219.
In the fourth quarter of 2024, the company expects to report top-line 26-week data from the phase IIb portion of the COVALENT-111 study with approximately 200 patients. Top-line data readout from the phase IIa portion of the COVALENT-112 study of the candidate, with approximately 20 patients, is also expected in the fourth quarter.
Additionally, Biomea stated that it will announce a third development candidate, a potent, selective, oral small molecule GLP-1 receptor agonist, by the end of this year.