In a coordinated release of information today, Dr. Kevan Herold (Yale University) presented the PROTECT clinical trial results at the International Society for Paediatric and Adolescent Diabetes (ISPAD) conference simultaneous to the release of the published article in the New England Journal of Medicine, and a press release issued by Sanofi (who acquired Provention Bio in April 2023). The PROTECT trial investigated whether teplizumab (brand name: TZIELD) can delay the progression of type 1 diabetes (T1D) in newly diagnosed (stage 3 T1D) children and adolescents ages 8-17. Based on the results, it can.
Over 300 participants took part in the study, with 217 receiving teplizumab and 111 receiving a placebo treatment. The results showed:
- TZIELD was effective at helping to keep the beta cells working better, as shown by something called C-peptide, which is a measure of how well beta cells are functioning.
- Participants taking TZIELD needed slightly less insulin, and had slightly improved time-in-range compared to the placebo group, however, these results weren’t statistically significant.
- Tzield has the potential to slow the progression of Stage 3 T1D in newly diagnosed individuals
“This new study shows that Tzield can slow down the autoimmune attack on insulin-producing beta cells in children and adolescents newly diagnosed with T1D,” said Sarah Linklater, PhD, JDRF Canada’s Chief Scientific Officer.
“This is new evidence that we can successfully intervene during this window of opportunity right after diagnosis – a critical step towards cures. Slowing down progression also provides important health benefits for individuals with T1D in the short- and long term. We applaud Provention Bio and Sanofi’s ongoing dedication to advancing disease-modifying therapies for individuals with T1D. JDRF continues to support a large amount of research on disease-modifying therapies as there is enormous potential for these types of treatments to benefit people living with the condition.”
JDRF has supported the development of teplizumab for nearly 30 years, which includes contributions through research grants, federal funding via the Special Diabetes Program, a strategic investment by the JDRF T1D Fund that brought Provention Bio into T1D for the first time, and more.
Currently, TZIELD is only approved in the U.S. by the FDA for use in individuals with stage 2 T1D (pre-diagnosis), which is identified via screening. The use of TZIELD in individuals within 6-weeks of T1D diagnosis (within stage 3) has not been submitted for approval to any regulator.
JDRF Canada will continue to monitor ongoing news of Tzield and will provide updates as they become available.
