Biomea Fusion Inc. is preparing to announce crucial data updates this quarter for its leading drug candidate, Icovamenib, focusing on its potential in treating type 1 and type 2 diabetes. These readouts are from the COVALENT-111 and COVALENT-112 trials and are highly anticipated by investors and the medical community.
Icovamenib: Targeting Menin for Diabetes Treatment
Icovamenib is an orally administered, selective covalent inhibitor of menin. Menin plays a significant role in regulating the growth of beta cells in the pancreas and is implicated in oncogenic signaling across various cancers. By inhibiting menin, Icovamenib aims to modulate beta cell function, offering a novel approach to diabetes management.
COVALENT-111: Phase IIb Trial in Type 2 Diabetes
The COVALENT-111 trial is a Phase I/II study evaluating Icovamenib in type 2 diabetes. The Phase I portion, which assessed single ascending doses in healthy adults, has been completed. The Phase II portion involves multiple ascending doses in adult patients with type 2 diabetes whose condition is uncontrolled by standard-of-care medications. Following the Escalation phase, the study advanced to an Expansion Phase (Phase IIb), where type 2 diabetes patients are dosed for extended durations.
Biomea anticipates reporting topline 26-week data from approximately 200 patients in the Phase IIb portion of the COVALENT-111 trial in December 2024. This data is expected to provide insights into the drug's efficacy and safety profile over a longer treatment period.
COVALENT-112: Phase II Trial in Type 1 Diabetes
COVALENT-112 is a multi-site, randomized, double-blind, placebo-controlled Phase II study in adults with stage 3 type 1 diabetes. The trial compares two different doses of Icovamenib to placebo in a 1:1:1 ratio to assess the efficacy, safety, and durability of the drug. Approximately 150 patients will be enrolled and receive either Icovamenib or a placebo over 12 weeks, followed by a 40-week off-treatment observation period.
The trial also includes an open-label segment for adults diagnosed with type 1 diabetes within the past 15 years. This segment, involving 40 patients, is designed to evaluate the efficacy, safety, and durability of Icovamenib at two oral dose levels (100 mg and 200 mg) over a 12-week treatment period, followed by a 40-week off-treatment period.
Topline Week 26 data readout involving approximately 20 type 1 diabetes patients in phase IIa COVALENT-112 trial is also due in December 2024.
Regulatory Hurdles and Trial Resumption
In June, the FDA placed both the COVALENT-111 and COVALENT-112 trials on hold due to concerns about potential drug-induced hepatotoxicity observed during the Dose Escalation phase of the COVALENT-111 trial. However, after a thorough review of the data, the FDA approved the resumption of both trials earlier this month, allowing Biomea to proceed with its clinical development program.
Broader Clinical Program
Beyond diabetes, Icovamenib is also under investigation in Phase I trials for liquid tumors (COVALENT-101) and solid tumors (COVALENT-102). Biomea expects to complete the dose escalation portion of these trials by the end of the year.
Another key clinical program for Biomea is BMF-500, an orally bioavailable covalent inhibitor of FLT3, which is being developed for acute leukemia. The FLT3 protein is often overexpressed in leukemia. BMF-500 is currently in a Phase I study (COVALENT-103) involving patients with relapsed or refractory acute leukemia with both FLT3 wild-type and FLT3 mutations. The dose escalation portion of this study is also slated for completion by the end of 2024.
