MacroGenics and Lilly Achieve Targeted Patient Enrollment in PROTEGE, a Global Phase 2/3 Clinical Trial of Teplizumab in Type ...( Phase 3 PROTEGE ENCORE Clinical Trial...),Health

Phase 3 PROTEGE ENCORE Clinical Trial Initiated

ROCKVILLE, Md. and INDIANAPOLIS, June 16 /PRNewswire/ -- MacroGenics, Inc. and Eli Lilly and Company (NYSE: LLY) today announced that the PROTEGE trial achieved its targeted patient enrollment. The trial is a pivotal Phase 2/3 clinical study evaluating teplizumab, an investigational compound under development for the treatment of individuals with recent-onset type 1 diabetes.

The PROTEGE trial is a randomized, double-blind, multi-center, multi-national, 4-arm, controlled study designed to evaluate the safety and efficacy of teplizumab in individuals with recent-onset type 1 diabetes, aged 8 to 35, who are within 12 weeks of their diagnosis. More than 530 individuals are enrolled in the study across 14 countries, including the United States. The primary composite endpoint for PROTEGE includes both the patient's total daily insulin usage and his/her HbA1c levels at 12 months. Secondary endpoints are evaluated at 24 months. Longer term safety and efficacy data from patients who complete the PROTEGE trial are being collected in a separate Phase 3 study called the PROTEGE Extension trial.

"The completion of enrollment of the PROTEGE study is an important milestone for MacroGenics and for the type 1 diabetes research community," stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We appreciate the dedication of the patients, their caregivers and clinical investigators who helped advance this important late-stage clinical trial."

The companies also announced today that they have initiated the PROTEGE ENCORE trial, another Phase 3 global study of teplizumab in individuals with recent-onset type 1 diabetes, designed to capture patient-reported outcome measures in addition to safety and efficacy data. Information about the PROTEGE and PROTE
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