ConjuChem Completes Dosing in Phase II Diabetes Trial
ConjuChem Biotechnologies has completed dosing in its Phase II clinical trial of PC-DAC:Exendin-4, a modified Exendin-4 analog that is being developed for Type II diabetes.
This Phase II trial was a randomized, double-blind, placebo-controlled, multiple dose study that evaluated the efficacy and safety of three months of weekly injections of PC-DAC:Exendin-4 in patients with Type II diabetes not adequately controlled by metformin monotherapy.
The trial enrolled approximately 120 evaluable patients randomized to one of three parallel treatment groups: a 1.5mg fixed-dose weekly cohort; a 1.5mg weekly dose titrating to 2mg at the fifth week cohort; and a placebo group. Top line data from the trial will be announced in December 2008.
The company also announced the results of a preclinical study evaluating the pharmacodynamics of its PC-Insulin versus Lantus (insulin glargine (rDNA) injection) after repeated daily subcutaneous administration in streptozotocin-induced diabetic rats. A similar reduction in blood glucose was observed with both compounds at two, six and eight hours after each dose but glucose levels at 24 hours were only normalized in animals treated with PC-Insulin.
In addition to a superior control of blood glucose, PC-Insulin was more effective in normalizing physiologic parameters such as water intake in the diabetic rats. The company plans to submit an investigational new drug aplication in mid-2009.
Thomas Ulich, executive vice president of ConjuChem, said: “We are very encouraged with the emerging profile of PC-Insulin and believe it can achieve our objective of a more peakless basal insulin with a longer duration of activity.”