JDRF’s industry partner MacroGenics, a Maryland-based biotechnology company, and its commercial partner Eli Lilly announced that its ProtÃ©gÃ© Phase III clinical trial of teplizumab to treat recent-onset type 1 diabetes did not meet its primary efficacy endpoints during a one-year review. The goal of the ProtÃ©gÃ© trial was to assess the drug’s capacity to reduce an individual’s insulin requirements and HbA1c levels (a measure of metabolic control that reflects the amount of glucose in a patient’s blood over a three-month timeframe) while maintaining relatively normal blood sugar levels.
Based on this lack of efficacy, the companies decided to suspend further enrollment and dosing in two other ongoing trials of the drug in people with type 1 diabetes. MacroGenics and Eli Lilly are currently reviewing the data from the ProtÃ©gÃ© trial to better understand the outcome and determine next steps. This study was not halted due to safety concerns. MacroGenics reports that the Data Monitoring Committee did not identify any unanticipated safety issues.
It is important to note that this trial was testing a specific type of anti-CD3 antibody at a specific dose during a defined stage of the disease (within three months of diagnosis). There are several other ongoing trials testing the same and other anti-CD3 drugs at different doses and at different stages of the disease (established and pre-diabetes), including Tolerx’s otelixizumab product which is currently in advanced Phase III testing. It is our understanding that Tolerx’s otelixizumab clinical development activities are unaffected by the recent news. JDRF will continue to report on ongoing developments as information becomes available.
To access the announcement from MacroGenics, please click here.