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news.The FDA has cleared ConjuChem's phase I/II protocol for the treatment of type 2 diabetes using the company's proprietary PC-DAC:Exendin-4 compound. This allows patient dosing to begin in mid-March.
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Exendin-4 is a glucagon-like peptide-1 (GLP-1) homolog and an agonist for the GLP-1 receptor. It lowers blood glucose levels through a distinct mechanism complementary to the mechanisms of action of currently available anti-diabetic drugs.
Historically, the clinical utility of Exendin-4 has been limited by its relatively short half-life in plasma. However, PC-DAC:Exendin-4 is a modified Exendin-4 analogue that is bonded to recombinant human albumin (Recombumin, provided by Delta Biotechnology). This preformed conjugate has a much longer half-life than its natural counterpart.
The phase I/II trial will be a randomized, double-blind, single escalating dose study. The study will evaluate the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetic and pharmacodynamic profile of PC-DAC:Exendin-4 in patients with stable type 2 diabetes.
The study will enroll up to 68 patients with HbA1c levels between 6.5% and 11% and will consist of six cohorts (plus two optional cohorts) and a MTD group.
“We are excited to start this clinical program with PC-DAC:Exendin-4 which should ultimately confirm the positive efficacy and the excellent tolerability profile we saw for this compound in our preclinical studies,” said Dr Jean-Paul Castaigne, COO of ConjuChem. “Moreover, we expect the data to support our efforts to produce a once-per-week GLP-1 receptor agonist compound.”
Preliminary data is expected to be available in mid-2006 and, following the completion of this study, ConjuChem intends to start a phase I/II multiple dose trial.