MacroGenics, Inc. announced results from Protégé, a Phase 3 clinical study of teplizumab in type 1 diabetes.
Exploratory, post-hoc analyses suggest that when used in a 14-day full dose regimen, teplizumab, an anti-CD3 monoclonal antibody, preserves C-peptide and increases the percentage of patients requiring very low doses of insulin with good glycemic control (glycosylated hemoglobin) compared to placebo.
In addition, these analyses revealed that certain subpopulations may be more likely to respond to teplizumab treatment.
Protégé is a two-year, randomized, double-blind, placebo-controlled clinical trial, with 513 patients aged 8 to 35, recently diagnosed with type 1 diabetes, who were enrolled and treated at 83 clinical centers in North America, Europe, Israel, and India.
Participants were allocated to receive daily infusions of teplizumab (full dose for 14 days, one-third dose for 14 days, or full dose for 6 days) or placebo at baseline and at 6 months.
The primary composite endpoint of the Protégé study was the percentage of patients with insulin use at one year. Although teplizumab was shown to have an acceptable safety profile, the primary endpoint was not achieved, as had been previously announced in a joint communication with Eli Lilly and Company in October 2010. Protégé is ongoing and will complete the two-year follow-up in 2011.
A greater proportion of patients in the teplizumab groups were able to discontinue or use very low doses of insulin compared to the placebo group. A reduced insulin requirement while maintaining glycemic control appears to support teplizumab having a biological effect.
“Although the Protégé study missed its primary endpoint, the data appear to indicate that teplizumab has a desired biological effect in certain subpopulations with a potentially meaningful therapeutic benefit for patients with recent-onset type 1 diabetes,” says Scott Koenig, president and CEO of MacroGenics. “These groups include patients for whom treatment is begun ? 6 weeks after diagnosis and in children 8 to 11 years old.”
The findings were published in The Lancet.
Release Date: June 28, 2011
Source: MacroGenics, Inc. https://www.macrogenics.com/press_releases-298.html
Filed Under: Drug Discovery