Encouraging Beta Cell Trial Results Show A1C Reduction in Type 2 Diabetes
Researchers released clinical trial data on a new treatment for type 2 diabetes that may help the body’s insulin-producing cells regenerate. 78% of the clinical trial’s participants who received the treatment reduced their A1C by at least 0.5 percentage points in four weeks.
Biomea Fusion, a precision biotechnology company, released results from its clinical trial for an experimental type 2 diabetes therapy. The treatment, currently known as BMF-219, takes a novel approach to addressing insulin production in people with type 2 diabetes.
When someone has type 2, their body’s cells cannot use insulin efficiently. Pancreatic beta cells, the cells that produce the body’s insulin, respond by working harder, but in some people, this results in progressive loss of beta cell function and type 2 diabetes.
Unlike most type 2 diabetes treatments today, BMF-219 works by promoting the recovery of beta cells to restore the body’s natural ability to make insulin. The drug is an oral medication known as a menin inhibitor – menin is a protein that blocks beta cells from growing and multiplying. By inhibiting menin with BMF-219, researchers hope that the drug will increase the beta cells’ ability to make insulin.
Biomea Fusion is investigating BMF-219 in the COVALENT-111 study, an ongoing phase 2 clinical trial that has 40 participants thus far. After four weeks, 78% of participants had reduced their A1C by at least half a percentage point, and 56% had reduced A1C by more than one full percentage point; participants had an average A1C of 7.9% at the start of the trial.
The treatment seemed to have minimal side effects and was generally well-tolerated; all participants completed the four-week treatment with no adverse events or reductions in dosing.
Going forward, researchers at Biomea Fusion plan to examine the effects of higher doses of BMF-219, or for dosing periods longer than four weeks. A follow-up with participants four weeks after stopping treatment showed that some participants continued to have lower A1C. However, researchers still need to learn how long the drug effect may last.
As of now, the treatment is being studied exclusively in people with type 2 diabetes, but in the future, the company also plans to explore the potential for use in people with type 1 diabetes.
In the company’s press release, Thomas Butler, Biomea Fusion’s CEO and chairman of the board, said, “BMF-219 may indeed be capable of regenerating, preserving, and reactivating healthy, functional beta cells. We are seeing this impact and high level of glycemic control after just 4 weeks of treatment, a remarkably short timeframe, and at the first dose level, with highly favorable safety and tolerability.”
For those who are interested, the trial is actively recruiting adults who have type 2 diabetes, and also those without diabetes. See additional information about study locations and how to contact the study team here.