ConjuChem Releases Preliminary Findings on Type 2 Diabetes Treatment

ConjuChem Biotechnologies has announced positive preliminary results from its Phase I/II multiple-dose clinical study for the treatment of Type 2 diabetes using the company's proprietary PC-DAC:Exendin-4.

The study demonstrated that PC-DAC:Exendin-4 was generally well tolerated and, when administered once weekly at each of the dosing levels tested, lowered blood glucose.

The trial, a randomized, double-blind, multiple-dose study, evaluated the safety and tolerability of the treatment in patients with stable Type 2 diabetes. Pharmacokinetic and pharmacodynamic parameters were also evaluated.

All patients were on stable doses of metformin with HbA1c levels between 7 and 10.6 percent. The trial enrolled 70 patients at seven centers in the U.S. and Canada, with patients randomized to one of four parallel treatment groups: 1, 2 or 3 mg of treatment or placebo.

Reductions in mean fasting plasma glucose were statistically significant in all treatment groups versus baseline and placebo over the five-week treatment period. The average reductions from baseline values for the 1-, 2- and 3-mg treatment arms were 9 percent, 11 percent and 7 percent, respectively, versus 1 percent in the placebo group.

HbA1c improved in all three treatment groups with median HbA1c decreasing 0.7 percent, 0.8 percent and 0.9 percent in the 1-, 2- and 3-mg groups by the end of the study period. The placebo group had declined 0.2 percent at the end of the study period.

ConjuChem said it intends to submit the study results for presentation at a scientific meeting this year. In conjunction with the multidose results, ConjuChem also reported that ongoing product development programs, including manufacturing process improvements, are expected to be completed in time to be included in a Phase II study, which is planned for initiation by the end of the year.

Exendin-4 is a Glucagon-like peptide-1 homolog and an agonist for the GLP-1 receptor. Exendin-4 decreases glucagon and increases insulin secretion in a glucose-dependent manner. The clinical utility of Exendin-4 is somewhat limited by its relatively short half-life in plasma. Developed with ConjuChem's proprietary PC-DAC technology, PC-DAC:Exendin-4 is a modified Exendin-4 analogue that is covalently bound to recombinant human albumin. The preformed albumin-peptide conjugate has a much longer half-life than the peptide alone.