Sanofi treatment could slow type 1 diabetes progression

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TZIELD (teplizumab-mzwv) has demonstrated TZIELD’s potential to slow disease progression in newly diagnosed children and adolescents with Stage 3 type 1 diabetes.

Data from the Phase III PROTECT clinical trial, presented at the 2023 Annual ISPAD Conference, showed that superior beta cell preservation was observed compared to placebo. 

As the primary endpoint, 94.9 percent of participants in the TZIELD group maintained peak C-peptide levels ≥0.2 pmol/mL. This was compared with 79.2 percent of those who received the placebo at the trial’s completion at 78 weeks.

PROTECT trial results

The trial enrolled 328 children and adolescents. There were 217 participants given TZIELD and 111 given placebo.

On average, patients administered with 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 hypoglycemic events were similar among both study groups.

While no new safety signals were identified, Sanofi stated the study’s key secondary endpoints did not meet statistical significance.

About TZIELD

The CD3-directed monoclonal antibody treatment is the first and only disease modifying therapy in type 1 diabetes, according to Sanofi. It was approved in November 2022 to delay the onset of Stage 3 type 1 diabetes in adults and children eight years and older diagnosed with Stage II type 1 diabetes.

As Type 1 diabetes is driven by the destruction of the insulin-producing beta cells, explained Dr Kevan Herold, Long Professor of Immunobiology and of Medicine (Endocrinology), Yale School of Medicine and Primary Investigator of PROTECT, “beta cell preservation remains a meaningful unmet need for all patients with diabetes.”

“The PROTECT results are encouraging, as we believe they showcase the potential for TZIELD to slow down the progression of Stage 3 type 1 in this population, as well as pointing towards favorable trends in relevant aspects for clinicians and people living with type 1 diabetes,” noted Dr Jose Eduardo Neves, Senior Vice President of Global Head of Medical Affairs for General Medicines at Sanofi.

The full data set was published in The New England Journal of Medicine.

An observational extension study following participants for a further 42 months is ongoing.

Release of the PROTECT trial data follows the company’s acquisition of Provention Bio (a Sanofi Company) in April 2023 and therefore represents a key milestone for Sanofi.