Andromeda Biotech Ltd. said Tuesday a late-stage study of its Type 1 diabetes drug DiaPep277 met its primary endpoint of insulin preservation, along with an improvement in glycated hemoglobin level in phase 3 trial.
Andromeda is a part of Israel-based Clal Biotechnology Industries Ltd. and is focused on developing novel drugs for autoimmune diabetes. Teva Pharmaceutical Industries Ltd. (TEVA), which has a stake in Andromeda, has sole worldwide license for DiaPep277.
The 24-month placebo-controlled trial of DiaPep277 had a primary point of change from baseline in C-peptide levels, a marker for assessing insulin secretion by pancreatic cells. Results showed that decline in C-peptide levels was more pronounced in the placebo arm than in the treated group.
The study also achieved a key secondary endpoint, showing that a greater proportion of DiaPep277 treated patients maintained good diabetic control compared to the placebo. The drug was also found to be well tolerated.
Andromeda said further efficacy and safety data analysis from this study are ongoing. A second confirmatory Phase III study with DiaPep277 is currently being conducted, and completion of patient recruitment is anticipated by the first half 2012.
The late-stage study included 457 newly diagnosed Type 1 diabetes patients aged 16 to 45, who received daily insulin therapy adjusted to their blood glucose levels. Also, patients who were randomized in the treatment group were injected subcutaneously with 1 mg of DiaPep277 once every three months for two years.
Andromeda's DiaPep277 is a unique peptide of 24 amino acids derived from the sequence of the human heat shock protein 60.
The peptide is said to act by modulating the immune system, thus preventing the destruction of pancreatic cells that secrete insulin. To date, there is no therapy able to slow the progressive destruction of insulin secreting pancreatic beta cells in Type 1 diabetes, or T1D.
The company said that initially DiaPep277 is targeted to treat newly diagnosed T1D adult patients with residual insulin secreting cells. Additional target populations include newly diagnosed children with T1D, patients with a high risk of developing T1D, and T1D patients with slow progressing disease.
TEVA is trading at $38.23, down $0.22 or 0.57%, on a volume of 1.2 million shares on the Nasdaq.
On the Israel stock exchange, shares of Clal Biotechnology, trading under the ticker CBI.TA, surged 10.15% to touch 1,921.00 Israeli shekels.
by RTT Staff Writer
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