Researchers at Johns Hopkins School of Medicine tested a monoclonal antibody drug that may prevent and reverse type I diabetes in a study on mice. The monoclonal antibody, called mAB43, is designed to target insulin-producing beta cells in the pancreas and protect these cells from attack by the body's immune system. The results were: published Today is Diabetesa publication of the American Diabetes Association.
Type 1 diabetes is an autoimmune disease in which lymphocytes target insulin-producing beta cells. Approximately 2 million people in the United States have type 1 diabetes, including approximately 304,000 children and adolescents.
mAB43 targets zinc transporter 8 (ZnT8), an autoantigen present on the surface of beta cells in patients with type 1 diabetes. Doctors test for this antigen to distinguish between type 1 and type 2 diabetes.
This is another mechanism targeted by Tzield (teplizumab-mzwv), the only available monoclonal antibody that delays the onset of type 1 diabetes. Tzield is an anti-CD3 directed antibody approved in November 2022. Developed by Provention Bio, which Sanofi acquired in April 2023, Tzield binds to CD3 on T cells and inactivates immune cells that attack beta cells. Tzield has been shown to delay the onset of stage 3 type 1 diabetes by about two years.
Researchers at Johns Hopkins University, led by Dr. Dax Fu, associate professor of physiology at Johns Hopkins University School of Medicine, tested 64 nonobese mice with type 1 diabetes with a once-weekly dose of mAb43 if the mice were obese. was injected intravenously. 10 weeks after birth. After 35 weeks, all mice were no longer diabetic. One of the mice developed diabetes for a period, but recovered by week 35.
In five additional mice, the researchers began administering mAb43 weekly at 14 weeks of age and continued treatment and monitoring for up to 75 weeks thereafter. Researchers said one in five people in the group developed diabetes, but no adverse events were found.
All mice that received mAb43 at week 10 were still alive at week 75. Mice in the control group, which received no drug, lived for 18 to 40 weeks.
The researchers also used the biomarker Ki67, a protein found in dividing cells, and found that beta cells regenerated at a reduced rate. The researchers showed that after treatment, immune cells retreated from the beta cells and the amount of inflammation in the area decreased.
Although this is an early study, researchers speculate that this new antibody may delay the onset of diabetes longer than Zield and has a better safety profile for chronic use.
Released by Sanofi New data published In October 2023, Tzield was shown to be able to slow beta cell loss and preserve beta cell function in children and adolescents ages 8 to 17 who have recently been diagnosed with stage 3 type 1 diabetes.
The PROTECT clinical trial was a randomized, placebo-controlled study evaluating mean C-peptide levels at week 78. C-peptide levels are a measure of how much insulin your body produces. Low levels are associated with a diagnosis of type 1 diabetes. In the PROTECT trial, more patients who received Tzield were able to maintain their C-peptide levels compared to those who received a placebo.
