CombinatoRx, Incorporated has completed patient enrolment in COMET-1 (CRx-102 Osteoarthritis Multi-center Evaluation Trial), the company's phase 2b clinical trial designed to evaluate the safety and efficacy of CRx-102 in subjects with symptomatic knee osteoarthritis.
The COMET-1 clinical study has been overenrolled, with 279 patients participating. CRx-102 is an oral synergistic combination drug candidate in development for immuno-inflammatory diseases, including osteoarthritis and rheumatoid arthritis, a company release stated.
"The completion of enrolment in COMET-1 is an important milestone for CombinatoRx. We are grateful to the investigators and patients for participating in this study and look forward to reporting results in the second half of 2008," said Alexis Borisy, president and CEO of CombinatoRx. "We are also actively enrolling patients in MARS-1, a 600+ patient Phase 2b study of CRx-102 in rheumatoid arthritis. CRx-102 has already demonstrated clinical efficacy in hand osteoarthritis with statistically significant reductions in pain and stiffness and in rheumatoid arthritis with statistically significant improvements in ACR20 and DAS28 scores."
CRx-102 is a novel dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. CRx-102 contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed in a uniquely engineered formulation. CRx-102 is thought to act through a novel multi-target mechanism of action in which dipyridamole synergistically and selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities by inhibiting key cell mediators of inflammation. In proof-of-concept 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 in phase 2 clinical development for the treatment of rheumatoid arthritis and osteoarthritis.
CombinatoRx, Incorporated (CRXX) is pioneering the new field of synergistic combination pharmaceuticals and has a broad product portfolio in phase 2 clinical development.