CONJUCHEM ANNOUNCES FINAL RESULTS OF TYPE 2 DIABETES TRIAL
ConjuChem Biotechnologies has announced that final data from its Phase I/II, single-escalating-dose study for the treatment of Type 2 diabetes using the company's proprietary PC-DAC:Exendin-4 compound shows an excellent tolerability profile, positive efficacy on glucose reduction and extended duration of activity.
The trial, a randomized, double-blind study, evaluated safety and tolerability of PC-DAC:Exendin-4 as monotherapy in patients with stable Type 2 diabetes who had discontinued their oral anti-diabetic medications starting one week before the start of the trial. As secondary endpoints, pharmacokinetic and pharmacodynamic parameters were evaluated.
Six cohorts were dosed subcutaneously at 310, 620, 1,250, 2,500, 3,750 and 5,000 micrograms of the drug. The product is a highly soluble liquid formulation that is injectable in a small volume with a small-gauge needle. Each cohort consisted of seven patients, six active and one placebo. The mean glucose values at baseline of the cohorts (without placebo) were 15.6, 12.2, 12.1, 11.2, 9.6 and 16.2 mmol/L, respectively.
Exendin-4 is a Glucagon-like peptide-1 (GLP-1) homolog and an agonist for the GLP-1 receptor. Exendin-4 decreases glucagon and increases insulin secretion in a glucose-dependent manner. Exendin-4 may stimulate B-cell proliferation, restore B-cell sensitivity to glucose, delay gastric emptying and increase peripheral sensitivity to glucose. 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.
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