Biomea Fusion’s T1D Practical Cure Trial Terminated

November 20, 2025

Biomea Fusion, a clinical-stage biopharmaceutical company focused on creating small molecules to treat diabetes and obesity, terminated its phase II Practical Cure trial, COVALENT-112. The trial tested icovamenib (a.k.a. BMF-219), a menin inhibitor designed to protect and encourage the regeneration of beta cells. The termination was not detailed in corporate filings or press releases.
 

About COVALENT-112

COVALENT-112 qualified as a Practical Cure along the Immune System Modification and Cell Regeneration research pathways. It tested two oral dosages of icovamenib, a covalent, small-molecule menin inhibitor. Menin is a protein thought to negatively interfere with beta cell health. By inhibiting menin, the drug sought to protect beta cells from the autoimmune attack and encourage their regeneration and proliferation.

The T1D study began in December 2023. Thirty-seven patients were enrolled in the trial, including individuals with early onset or long-established T1D. 
 

Early Results and FDA Hold

Early results were released in April 2024 for two participants. Both individuals had fully established T1D; one diagnosed three years prior and one diagnosed seven years prior. Both experienced a modest increase in fasting c-peptide, which is a positive indication. However, no results were released for the other thirty-five participants during the trial’s duration.

Two months after these results, the trial was temporarily placed on an FDA clinical hold due to liver toxicity concerns in a related T2D trial, COVALENT-111. After a three-month review period, the hold was lifted and Biomea was given the green light to continue, though this affected the number of patients who were able to complete the study.

No further trial results were shared.
 

Biomea’s Future in T1D

According to the US clinical trial database, the reason for the trial’s termination was due to Biomea Fusion’s “business decision to terminate the study based on prioritization of portfolio.” 

Though several corporate highlight announcements still refer to icovamenib as a treatment for T2D and T1D, all references to T1D as part of the company’s current development pipeline have been removed.

JDCA inquired as to why the trial terminated, if this is a pivot away from T1D to T2D and obesity entirely, and if Biomea would still pursue T1D research in the future. A representative responded to our inquiries:

"Our current focus reflects where we can most efficiently reach late-stage development, specifically in severe insulin deficient Type 2 diabetes and in obesity, but this does not reflect a reduced commitment to T1D . . . .We continue to view T1D as an important area of unmet need, and we are very interested in further studying icovamenib in this setting. We believe menin inhibition and beta cell restoration may have therapeutic relevance in T1D, and we plan to revisit the optimal study design and timing once we have the appropriate resources and a clearer picture from our broader program."

JDCA will keep you up-to-date on the latest T1D news as it unfolds.

*This report has been updated following additional context provided by the company after publication.