The US Food and Drug Administration (FDA) has granted clearance to Biomea Fusion’s investigational new drug (IND) application, enabling the initiation of the Phase II COVALENT-112 clinical trial of BMF-219 for the treatment of type 1 diabetes (T1D).
The aim of the placebo-controlled, multi-site, double-blind, randomised study is to assess the durability, efficacy, tolerability and safety of the covalent menin inhibitor BMF-219 in restoring beta cell function.
It will compare BMF-219 100 mg and 200 mg doses against placebo control.
Nearly 150 adults with stage 3 type 1 diabetes in an unfed condition will receive these dosages in a 1:1:1 manner for 12 weeks, followed by a 40-week off-treatment period.
Biomea Fusion CEO and Board chairman Thomas Butler said: “We have been diligent to build a programme that will evaluate most people with diabetes, including those with type 1 diabetes.
“I am immensely proud that Team Fusion has achieved these clinical and regulatory milestones more than three months ahead of our guided timelines.
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“We have now established a clinical development plan that we believe will fully explore the potential of BMF-219 across the spectrum of diabetes. The next quarters will be very exciting, as we expect these studies will begin to read out.”
BMF-219 has been shown to regenerate and retain insulin-producing beta cells in animal models of type 1 and type 2 diabetes in preclinical studies.
The company is also engaged in developing covalent small molecules to treat patients with genetically defined cancers.