Promising initial results from a Phase 3 trial of DiaPep277 have raised hopes that an alternative to insulin may soon be available to treat type 1 diabetes.
Promising initial results from a Phase 3 trial have raised hopes that an alternative to insulin may soon be available to treat type 1 diabetes. If the trial proves successful, it could mean that the world’s leading generic-drug making company, Teva Pharmaceutical Industries Ltd., has managed to do what other pharmaceutical companies before it have failed to do: find a drug that preserves the body’s ability to make insulin.
The new treatment is DiaPep277, a compound fashioned from a human protein that prevents the body’s immune system from obliterating insulin-producing pancreatic beta cells. Preliminary results from the trial in question have showed that the drug sustains balanced sugar levels in the blood.
The trial included 457 recently diagnosed type 1 diabetes patients between the ages of 16 and 45. Participants were divided into a placebo group, which received daily insulin injections, and a treatment group, which received 1 mg of DiaPep277 via subcutaneous injection every three months in addition to daily insulin injections.
The trial has also found that those taking DiaPep277 showed stable C-peptide levels—meaning that pancreatic cells were secreting insulin by themselves—while patients in the placebo group showed a decline in C-peptide levels.
Patients taking DiaPep277 also demonstrated “good diabetic control” in comparison to diabetic patients in the placebo group, according to a press release from Andromeda Biotech Ltd., Teva’s partner in this venture. This finding could translate to patients requiring fewer daily doses of insulin, decreasing their risk of future heart disease and stroke as a result of excess insulin levels, the release added.
A second Phase 3 trial of DiaPep277 will most likely include 450 patients in the US, Canada, Europe, Israel, and Argentina; enrollment is expected to be completed by the middle of 2012. Shlomo Dagan, PhD, CEO of Andromeda Biotech, reported that data from the two-year study is due out in 2014, and the company will use it to apply for approval in the US and Europe.
“We are very excited about the prospect of DiaPep277 bringing new hope to newly diagnosed type 1 diabetes patients and their families, especially after other potential late stage products failed to show significant efficacy in immune intervention,” said Dagan in the press release.
The search for new pharmaceutical treatments for type 1 diabetes—and the development of DiaPep277 itself—have proceeded haltingly in recent years. According to Bloomberg News, DiaPep277 has undergone development by Peptor Ltd. and its successor companies DeveloGen AG and Evotec AG. In 2002, Aventis SA—which became Sanofi—licensed DiaPep277 but returned the rights two years later.
Eli Lilly & Co. and partner MacroGenics Inc. were forced to scrap their experimental type 1 diabetes drug teplizumab when it was shown to be ineffective at slowing the progression of the disease in a critical trial. Further, Diamyd Medical AB ended an agreement with Johnson & Johnson to create a type 1 diabetes treatment this June following the failure of the drug to meet its primary goal in a late-stage trial.