The US Food and Drug Administration (FDA) has placed a full clinical hold on Biomea Fusion’s ongoing Phase I/II clinical trials assessing 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.
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Following the FDA notice, Biomea Fusion will continue to collect safety and efficacy data during the clinical hold.
The regulatory decision was based on the potential drug-induced hepatotoxicity levels observed in the concluded dose escalation phase of the COVALENT-111 trial.
Liver enzyme elevations were noted in dose escalation studies, which could be associated with higher doses, dietary intake, medical history, and concurrent medications.
Despite the hold, it is reported that most adverse events (AEs) in the trials have been mild to moderate without any serious adverse reactions (SARs) reported.
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By GlobalDataThe multi-site, double-blind, placebo-controlled Phase I/II COVALENT-111 study has completed its Phase I portion where healthy individuals were assessed for safety at varying dosing levels.
Phase II portion involves multiple ascending dose cohorts in type 2 diabetes patients.
The double-blind, placebo-controlled COVALENT-112 trial is designed to assess BMF-219 in 150 adults with stage 3 type 1 diabetes.
The trial aims to compare two doses of BMF-219 versus placebo to determine the drug’s efficacy, safety, and durability.
Biomea Fusion CEO and board chairman Thomas Butler said: “We respect the FDA’s decision and agree that patient safety is paramount and our top priority. We are fully collaborating and working diligently with the FDA to put a plan in place as quickly as possible to ensure patient safety and look forward to resuming the studies once we have authorisation from the FDA.
“The results to date have supported that BMF-219 is generally well-tolerated and can restore glucose-controlled insulin production and improve glycemic control. Based on the totality of the safety and efficacy data for BMF-219 in diabetes to date, we remain committed to advancing BMF-219 with its potentially transformative profile.”
In October last year, the company received FDA clearance for an investigational new drug (IND) application to commence the Phase II COVALENT-112 trial of BMF-219 for type 1 diabetes.
