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Long-term analysis shows sustained delay of clinical T1D by ~3 years1

The Kaplan-Meier curve shows the sustained delay of T1D for approximately 3 years in the teplizumab group. The updated data, with the long-term follow-up by TrialNet of the TN-10 study cohort, were presented as an oral presentation at the American Diabetes Association Scientific Sessions in June 2020.1

Kaplan-Meier curve of time to T1D with number of patients at risk1,2

T1D Illustration
  • The median follow-up of the updated analysis was 912 days1
  • Median time to diagnosis is 59.6 months in the teplizumab-treated group compared to 24.4 months in the placebo group (hazard ratio=0.457, p=.01)1
  • At the time of this analysis, 50% of patients in the teplizumab group and 22% in the placebo group were free from clinical T1D1
  • The percent estimate of T1D free at 5 years: 46.6% of teplizumab-treated patients but only 16.4% of the placebo-treated group1
  • Of note, some patients have yet to develop diabetes >8.5 years from start of treatment2

In addition, we show the primary endpoint from the TN-10 study published in 2019. The median time to T1D diagnosis was 48.4 months for the group treated with teplizumab, compared to 24.4 months for the placebo group.2

Decline of C-peptide reversed in teplizumab group1

T1D Illustration
  • C-peptide levels were not only stabilized but reversed/increased (p=.02) upon teplizumab treatment (comparison of teplizumab C-peptide AUC at 6 months vs baseline)1:
    • Placebo-treated patients kept declining (p=.002, teplizumab vs placebo, comparing the slope of the C-peptide AUC)
    • This not only confirms preservation of beta-cell function but also suggests restoration of dysfunctional beta-cell function

Improvement in C-peptide translated to3:

  • Improved (higher) total insulin secretory rate (p=.004)
  • Improved (lower) blood glucose levels (p=.04)
  • Correlation with induction of exhausted T cells (p=.01) and lower levels of inflammatory cytokines in these cells (p<.0001)

ANCOVA model fitted to baseline glucose AUC, age, and teplizumab showed a statistically significant effect of treatment with teplizumab to decrease the on-study mean glucose values vs placebo.

TN-10, efficacy: free from clinical T1D, annualized rate of T1D

  • At the end of the study, ~60% of teplizumab-treated patients were free of T1D, compared to ~30% of patients taking placebo2
  • The rate of T1D development was decreased by ~60%2
T1D Illustration

1. Sims EK, Bundy B, Stier K, et al. Teplizumab reverses the loss of C-peptide in relatives at-risk for type 1 diabetes (T1D). 80th Scientific Sessions: A Virtual Experience. American Diabetes Association. June 2020. 2. Herold KC, Bundy BN, Long SA, et al; for Type 1 Diabetes TrialNet Study Group. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613. 3. Data on file. Provention Bio, Inc. 2020.