Lilly suspends late-stage trials of diabetes drug Protege
pharmafile | October 22, 2010 | News story | Research and Development, Sales and Marketing | MacroGenics, Protege, diabetes, lilly, type I diabetes
Eli Lilly and its partner MacroGenics have suspended phase III trials of their investigational type I diabetes drug Protege after it failed to meet its primary endpoint.
Protege (teplizumab), a humanised, anti-CD3 monoclonal antibody, was being trialled to promote immune tolerance in type I diabetics.
But after a planned analysis of one-year safety and efficacy data the Protege Data Monitoring Committee (DMC) concluded the study’s primary efficacy endpoint, a composite of a patient’s total daily insulin usage and HbA1c glucose level at 12 months, was not met.
The DMC, noting that all administration of the experimental drug had been completed, said that appropriate safety monitoring is warranted. However, no unanticipated safety issues were identified in its review.
Lilly said in a statement that, following “careful evaluation” of the DMC’s recommendations for Protege, based on the lack of efficacy, the companies have “decided to suspend further enrollment and dosing of patients in two other ongoing clinical trials of teplizumab in type I diabetes”.
Gwen Krivi, VP of product development at Lilly Diabetes, added: “The failure to meet the primary endpoint is obviously disappointing for the millions of people who live with and treat type I diabetes.
“Lilly and MacroGenics will be considering all options for teplizumab in type I diabetes as well as the impact of the DMC’s recommendations on other potential indications.”
Scott Koenig, president and chief executive of US biotech MacroGenics, said his company remained “committed” to discovering and developing novel biologics for the treatment of autoimmune disorders, including type I diabetes.
The Protege Encore Trial, a second phase III trial of the same design as Protege, and the SUBCUE trial, a phase Ib trial that is exploring the subcutaneous administration in patients with type I diabetes, will now be suspended in light of the review.
Currently, there are few options for type I diabetics aside from multiple rounds of daily insulin injections.
Last year Roche bought into Bayhill’s BHT-3021 candidate, an antigen therapy designed to stimulate the patients’ own immune response for type I diabetics, currently undergoing phase II trials.
Protege works by binding to an epitope of the CD3-epsilon chain expressed on mature T lymphocytes and, by doing so, may modulate the pathological immunologic responses underlying multiple autoimmune diseases.
Ben Adams
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