Biomea Fusion Inc. (BMEA) is poised to unveil topline results from its COVALENT-111 phase IIb clinical trial of Icovamenib in type 2 diabetes. The announcement, scheduled for a conference call and webcast, will present 26-week data from approximately 200 patients. This data is eagerly awaited by investors, as reflected in the company's stock surge in premarket trading.
Icovamenib is an investigational, oral, potent, and selective covalent inhibitor of menin. Menin is a key transcriptional regulator with a direct role in regulating the growth of beta cells in the pancreas. It also plays a role in oncogenic signaling in multiple cancers. This mechanism of action sets Icovamenib apart, potentially offering a novel approach to managing type 2 diabetes by directly influencing pancreatic beta cell function.
The COVALENT-111 trial is structured in two phases. The phase I portion, which evaluated Icovamenib in healthy adults using single ascending doses, has been completed. The phase II portion consists of multiple ascending dose cohorts and includes adult patients with type 2 diabetes whose condition is uncontrolled by standard-of-care medicines. Following the Escalation phase, the study advanced into an Expansion Phase (phase IIb), involving multiple cohorts dosing type 2 diabetes patients for longer durations.
The topline results to be reported today are the 26-week data from approximately 200 type 2 diabetes patients in the phase IIb portion of the COVALENT-111 trial. The trial is designed to assess the efficacy and safety of Icovamenib in this patient population, providing crucial insights into its potential as a new treatment option for type 2 diabetes.
