The U.S. Food and Drug Administration (FDA) has fully halted Biomea Fusion’s ongoing Phase I/II clinical trial evaluating BMF-219 for type 1 and type 2 diabetes.
The hold affects the COVALENT-111 and COVALENT-112 trials of BMF-219, a covalent menin inhibitor.
Per the FDA notice, Biomea Fusion will continue to collect safety and efficacy data during the clinical trial hold.
The regulatory decision was based on the levels of potential drug-induced liver toxicity observed during the dose-escalation phase of the COVALENT-111 trial.
Elevations in liver enzymes have been observed in dose-escalation studies and may be related to dose increase, food intake, medical history, or concomitant medications.
Despite the holds, most adverse events (AEs) in the study were reported to be mild to moderate in severity, with no serious adverse reactions (SARs) reported.
The multicenter, double-blind, placebo-controlled Phase I/II COVALENT-111 trial has completed the Phase I portion evaluating safety in healthy subjects at different dose levels.
The Phase II portion will involve multiple ascending dose cohorts in patients with type 2 diabetes.
The double-blind, placebo-controlled study, COVALENT-112, is designed to evaluate BMF-219 in 150 adults with stage 3 type 1 diabetes.
The trial aims to compare two doses of BMF-219 to a placebo and determine the drug’s efficacy, safety and durability.
BioMare Fusion CEO and Chairman of the Board Thomas Butler said, “We respect the FDA’s decision and agree that patient safety is our top priority. We are cooperating fully with the FDA and are working diligently to implement plans to ensure patient safety as quickly as possible, and we look forward to resuming the study once FDA authorization is granted.”
“The results to date support that BMF-219 is generally well tolerated and can restore glucose-regulated insulin production and improve glycemic control. Based on the overall safety and efficacy data of BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile.”
The company received FDA approval in October last year for its Investigational New Drug (IND) application to initiate the Phase II COVALENT-112 trial of its type 1 diabetes treatment BMF-219.
“FDA Puts Full Hold on Biomea Fusion’s BMF-219 Diabetes Trial” was originally created and published by Clinical Trials Arena, a brand owned by GlobalData.
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