CRx-102 osteoarthritis multi-center evaluation trial (COMET) is designed to evaluate the efficacy of CRx-102 compared to placebo in subjects with symptomatic knee osteoarthritis.
This clinical trial is a multi-center, randomized, double-blind, placebo-controlled Phase IIb study evaluating the safety and efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis. Approximately 250 subjects are planned to be enrolled. The trial is a typical flare design and eligible patients with active disease will show an increase in knee pain (as determined by WOMAC pain scale) upon NSAID/COXIB withdrawal.
CRx-102 is an oral synergistic combination drug candidate containing the cardiovascular agent dipyridamole and an unconventionally low dose of the steroid prednisolone. CRx-102 works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone’s anti-inflammatory and immunomodulatory activities without replicating its side effects.
CombinatoRx says in Phase II clinical trials, CRx-102 demonstrated a powerful anti-inflammatory effect and rapid onset of action in patients with osteoarthritis and rheumatoid arthritis, and was generally well tolerated. CRx-102 is being developed in a modified-release commercial formulation for the treatment of multiple immuno-inflammatory diseases.