TZIELD®Phase 3 data presented at ISPAD shows potential to slow the progression of Stage 3 type 1 diabetes in newly diagnosed children and adolescents; full data simultaneously published in The New England Journal of Medicine

• TZIELD met the study’s primary endpoint, significantly slowing the decline of C-peptide levels, compared to placebo
• Numerical trends favoring TZIELD were seen in key secondary endpoints, whilst statistical significance was not achieved
• PROTECT builds on the existing body of evidence on TZIELD’s potential to slow the progression of type 1 diabetes
• TZIELD fits at the intersection of Sanofi’s growth in immune-mediated diseases and disease modifying therapies, and the company’s expertise in diabetes

Paris, October 18, 2023. New data from TZIELD’s (teplizumab-mzwv) PROTECT Phase 3 trial were presented today at the 49th Annual ISPAD Conference, in Rotterdam, The Netherlands. PROTECT studied the efficacy and safety of TZIELD, compared to placebo, to slow the loss of beta cells and preserve beta cell function as measured by C-peptide, in children and adolescents aged 8-17 years diagnosed in the preceding 6 weeks with Stage 3 autoimmune type 1 diabetes (T1D). The full data set has been simultaneously published in The New England Journal of Medicine.

TZIELD met the study’s primary endpoint, demonstrating superior beta cell preservation assessed by significantly slowing the decrease in mean C-peptide levels (area under the curve [AUC] after a 4-hour mixed meal tolerance test) at trial completion, compared to placebo. C-peptide is a biomarker for beta cell function. This significant difference indicates the potential of TZIELD to slow the progression of Stage 3 type 1 diabetes in this population. While the study’s key secondary endpoints did not meet statistical significance, numerical trends favoring TZIELD were seen in relevant clinical parameters. On average, people on TZIELD required numerically fewer insulin units and had numerically higher time in range, compared to those on placebo. HbA1c reductions and the overall rates of clinically important low blood sugar (hypoglycemic) events were similar among both study groups.

Kevan Herold, MDC.N.H. Long Professor of Immunobiology and of Medicine (Endocrinology), Yale School of Medicine and Primary Investigator of PROTECT.“Type 1 diabetes is a chronic autoimmune disease, driven by the destruction of the insulin-producing beta cells, and as such, beta cell preservation remains a meaningful unmet need for all patients with diabetes. These new results build on the findings from multiple studies across different stages of the disease process, further supporting TZIELD’s potential to modulate the progression of T1D.”

Jose Eduardo Neves, M.D.Senior Vice President, Global Head of Medical Affairs, General Medicines, Sanofi“The PROTECT results are encouraging, as we believe they showcase the potential for TZIELD to slow down the progression of Stage 3 T1D in this population, as well as pointing towards favorable trends in relevant aspects for clinicians and people living with type 1 diabetes. We look forward to discussing this new data with the scientific community and regulatory authorities around the world.”

The availability of the PROTECT data represents a key early milestone for Sanofi on TZIELD, following the acquisition of Provention Bio (a Sanofi Company) in April 2023. TZIELD is a strategic fit for Sanofi at the intersection of our growth in immune-mediated diseases and disease modifying therapies, and our company’s expertise in diabetes.

Key ResultsThe PROTECT clinical trial was a randomized, double blind, placebo-controlled, multi-national trial. From baseline and through the trial’s completion at 78 weeks, the following was observed for TZIELD vs placebo:

Primary endpoint

• Significantly less decrease in mean C-peptide levels (area under the concentration curve [AUC], following a 4-hour mixed-meal tolerance test [MMTT]): difference in least-squares means (LSM) of 0.13 pmol/mL; (95% CI: 0.09, 0.17; P70 but ≤180 mg/d. Clinically relevant hypoglycemic events were defined: level 2 hypoglycemia (