FDA lifts clinical hold on two trials assessing covalent menin inhibitor for diabetes
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Key takeaways:
- The FDA will permit the COVALENT-111 and COVALENT-112 trials to continue following a clinical hold.
- Elevated liver enzymes observed during dose escalation were not see in an expansion portion of COVALENT-111.
The FDA has lifted a clinical hold on two trials assessing an investigational treatment for people with type 1 and type 2 diabetes, Biomea Fusion announced.
On June 6, the FDA announced a clinical hold on the COVALENT-111 and COVALENT-112 investigating BMF-219 (Biomea Fusion), a covalent menin inhibitor, for the treatment of diabetes. According to a press release from Biomea Fusion, the hold was instituted due to potential drug-induced hepatotoxicity during the dose escalation phase of the COVALENT-111 study. COVALENT-111 is a phase 1/2 randomized, double-blind, placebo-controlled trial assessing BMF-219 in adults with uncontrolled type 2 diabetes despite taking standard medications. In the phase 2a portion of the study, participants were separated into multiple ascending dose cohorts and later continued into an expansion phase 2b portion of the trial with multiple dosing groups.
The company stated in its June 6 press release that elevated liver enzymes may have occurred during dose escalation due to higher doses, variations in diet, medical history and use of concomitant medications.
On Sept. 26, Thomas Butler, CEO and chairman of the board for Biomea Fusion, said the FDA lifted its hold as the safety signals in the dose escalation phase of the study were not observed during the phase 2b expansion portion of the trial.
“Most importantly, none of the elevated lab values translated to confirmed serious liver injury or liver impairment,” Butler said in a press release. “We look forward to continuing our robust development plan for BMF-219 following full resumption of our ongoing studies, COVALENT-111 and COVALENT-112.”
The FDA’s hold also impacted COVALENT-112 trial, a phase 2 study evaluating BMF-219 in adults with stage 3 type 1 diabetes. Participants were randomly assigned, 1:1:1, to two different dosing groups of BMF-219 or placebo for 12 weeks. The trial includes an open-label portion where 40 adults with type 1 diabetes for up to 15 years receive either 100 mg or 200 mg of BMF-219 for 12 weeks.
Biomea Fusion said it plans to release topline data from 200 participants in the phase 2b portion of COVALENT-111 and from 20 people participating in COVALENT-112 during the fourth quarter of 2024. The company also plans to announce a new investigational drug candidate, an oral GLP-1 receptor agonist, during the fourth quarter.
Reference:
Biomea Fusion announces BMF-219 in diabetes placed on clinical hold. https://investors.biomeafusion.com/news-releases/news-release-details/biomea-fusion-announces-bmf-219-diabetes-placed-clinical-hold. Published June 6, 2024. Accessed Sept. 27, 2024.
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