Biomea Returns to T1D Clinical Trial

At a Glance

• Last week, Biomea Fusion released positive 1-year results from the terminated phase II Practical Cure trial, COVALENT-112.
• Following positive reports, the company plans to initiate a new T1D trial this year, testing the same drug in early-onset patients.
• The drug being tested is icovamenib, designed to protect and regenerate beta cells.
• The new trial, in collaboration with four notable research centers, requires immunosuppression and is not considered a Practical Cure.
• JDCA is glad to see the company returning to and putting resources into T1D. 

Biomea Fusion, a biopharmaceutical company focused on diabetes and obesity, announced it will begin a new phase II clinical trial this year, following positive 1-year results from an earlier Practical Cure trial. These studies test an oral drug called icovamenib, a menin inhibitor designed to protect beta cells and promote their regeneration.

The new trial is different from its predecessor, using traditional immunosuppressants as an added means of protection and focusing solely on individuals with early-onset T1D. Therefore, in its upcoming mode of testing, it is not considered a Practical Cure. 
 

About Icovamenib

Icovamenib is a small-molecule menin inhibitor. Menin is a protein thought to limit beta-cell growth and contribute to beta-cell dysfunction. By stopping this action, Biomea believes it could regenerate and protect beta cells. The drug was previously tested in the phase II clinical trial, COVALENT-112, and included on JDCA’s Practical Cure list on the Immune System Modification and Cell Regeneration research pathways.

The ultimate intention is for icovamenib to be a one-and-done therapy. It is administered orally.
 

The Earlier Trial: COVALENT-112

The trial ran from December 2023 to July 2025, when it was terminated early.

Two doses of icovamenib were given every day for twelve weeks, followed by a forty-week observation period. Thirty-seven patients were enrolled, including adults with early-onset and established T1D. Of those thirty-seven, it is unclear how many completed the study.

COVALENT-112 was terminated after the FDA enforced a clinical hold (June-Sept 2024), reducing the number of patients able to complete the study. Subsequently, Biomea removed T1D from its clinical pipeline, citing other priorities, but shared its intent to return to T1D when it had the optimal study design and resources.
 

Recently Reported Trial Results from COVALENT-112

Last week, Biomea announced results from the COVALENT-112 trial. These were partial one-year data, but the company stated comprehensive results would be presented at the upcoming American Diabetes Association’s 86^th annual Scientific Sessions on June 5^th.

The trial tested both early-onset and fully established. In both groups, no new or unexpected safety issues occurred.

The results shared for early onset are generally positive. Five patients who were within three years of diagnosis saw the most benefit: Experiencing a 52% increase in C-peptide at week 12, with only a modest decline at one year.

The results shared for the fully established made little or no impact. Patients from three to fifteen years post-diagnosis noted no material change in C-peptide levels.
 

Next Steps: The New T1D Trial

Biomea has put T1D back into its research pipeline, planning a new phase II trial to test icovamenib, expected to start in the second half of 2026. It will recruit only early-onset patients and will include chronic immunosuppression drugs. In this testing format, unlike the earlier trial, it is not a potential Practical Cure.

The new trial will test a higher dose of icovamenib for six to twelve months in patients diagnosed within the last three years. The study will be conducted in collaboration with the Barbara Davis Center for Diabetes, Joslin Diabetes Center, University of Texas Health Science Center at San Antonio Diabetes Division, and the University of Miami Diabetes Research Institute.

Although this trial is not a potential Practical Cure, it is conceivable that a future test may include those with fully established T1D and omit immunosuppressants. If so, it would again be a Practical Cure, and we very much hope this is the case. JDCA is deeply appreciative of all efforts to address T1D, but it is also important to reiterate that a solution for early-onset does not address the problem for the millions of people who have been living with the disease for many years.

JDCA is committed to keeping you informed of the progress of this trial and any future evolution.