Type 1 Diabetes Worldwide Research | April 2023

Researchers are working tirelessly to find more effective ways to prevent and treat type 1 diabetes. They are developing new drugs and exploring innovative techniques for transplanting beta cells. These ongoing efforts offer hope for improved treatment options and better quality of life for those with type 1 diabetes. Here are some of the latest developments in the field:

New Vertex Type 1 Stem Cell Therapy Gets FDA Approval to Enter Clinical Trials
Vertex's stem cell therapy, VX-880, has been granted FDA clearance to enter clinical trials in the US. The therapy aims to replace damaged insulin-producing cells in people with type 1 diabetes with healthy beta cells derived from stem cells. However, a significant challenge is the need for immunosuppressive drugs to prevent the body's immune system from destroying the new beta cells. To overcome this challenge, Vertex is developing VX-264, an encapsulated stem cell therapy that physically protects the beta cells from the immune system while still allowing nutrients to reach them. The company plans to begin clinical trials for encapsulated insulin-producing stem cells in the first half of 2023.

4 Promising Clinical Trials
Late last year Provention's Tzield (teplizumab), an anti-CD3 monoclonal antibody, became the first and only drug approved for delaying the onset of type 1 diabetes. This year, four more trials aim to slow or delay type 1 diabetes progression, they include:

• Provention Bio's Tzield (teplizumab): Studying Tzield for treating children and adolescents with type 1 diabetes diagnosed within the past six weeks. The ongoing Phase III PROTECT trial involves 300 patients, with results expected later this year.
• Diamyd Medical's gamma-aminobutyric acid (GABA): The 35-patient Phase I/II REGENERATE-I trial is investigating Diamyd's remygen for adults with type 1 diabetes, with results expected in a few months.
• Imcyse's IMCY-0098: The Phase II IMPACT study of IMCY-0098 targets adults diagnosed with type 1 diabetes within the past nine weeks.
• ProKidney's Renal Autologous Cell Therapy (REACT): The REGEN-007 trial is evaluating whether two autologous renal cell injections can restore kidney function in patients with type 1 diabetes, type 2 diabetes, or chronic kidney disease.

These research areas hold promise for preventing and treating type 1 diabetes. However, it is essential to note that much of this work is still in the early stages and may not lead to new treatments in the near future.