Teplizumab to Delay/Prevent T1D Demonstrates Greater Efficacy
Building on last years’ extremely encouraging clinical trial with Teplizumab to delay/prevent the progression of T1D, Dr. Emily Sims (Indiana U) announced at the recent ADA conference even stronger results as they continue to track participants in the original study. Among those who have developed stage 3 symptomatic T1D, there is a 3 year delay in onset for the Teplizumab-treated group compared to the placebo group (60 months vs 24 months). Additionally, 47% of the Teplizumab -treated group have still not advanced to Stage 3 compared to 16% of the control (last year’s results: 57% and 28%, respectively). All the participants were at Stage 2 (autoantibody presence, abnormal glucose response) at trial initiation, so some beta cell loss was already present. But, most encouraging, teplizumab-treated participants demonstrated a “striking reversal” in c-peptide decline in the 6 months following treatment, indicating some recovery of beta cell function. Clinical trails are now progressing among newly diagnosed Stage 3 children (8-17), with Indiana U/Riley Children’s hospital in Indianapolis as one of the sites. The FDA has previously provided a Breakthrough Therapy Designation for Teplizumab, which should accelerate approval. Provention Bio, a company supported by the JDRF T1D Fund, is developing Teplizumab and it is possible that a FDA decision will be made by mid-2021.