The Phase Ib open-label, dose-escalating study will enroll up to 30 patients diagnosed with IgA nephropathy at clinical sites in Canada. The trial design utilizes a continuous reassessment method to evaluate safety of CCL2-LPM and to establish a maximum-tolerated dose.
Secondary endpoints for the Phase Ib clinical trial include an assessment of pharmacokinetics and biomarkers of disease associated with the mechanism of action of CCL2-LPM.
Osprey Pharmaceuticals USA is developing novel chemokine-enzyme fusion protein therapeutics, known as leukocyte population modulators (LPM), for the treatment of inflammatory and autoimmune diseases. CCL2-LPM selectively targets activated leukocytes expressing the chemokine receptor CCR2 that are responsible for initiating and maintaining a variety of inflammatory conditions.
Barbara Finck, chief medical officer of Osprey, said: “We are pleased to advance the first of our LPM compounds designed to target and neutralize chemokine-mediated inflammation into clinical trials. CCL2-LPM has shown a favorable pharmaceutical profile, demonstrating efficacy at low doses in models of glomerulonephritis, as well as tolerability at relatively high doses in preclinical toxicology testing.
“We are hopeful that the Phase Ib clinical trial of CCL2-LPM will provide us with indications of the compound’s biologic activity in addition to establishing safety. Initial results from the Phase Ib study are expected later in 2009.”