21. October 2009 08:18
CombinatoRx, Incorporated (NASDAQ: CRXX) today announced the results of a 12 month knee osteoarthritis (OA) Phase 2 extension trial for Synavive™ (CRx-102) at the American College of Rheumatology (ACR) 2009 Annual Meeting in Philadelphia. The data demonstrated that Synavive-treated subjects maintained efficacy levels throughout the 12 month extension trial. These findings further support the core study data, which was presented at EULAR in June 2009, in which knee OA efficacy was observed early in treatment and sustained throughout the three month core study in all WOMAC measurement subscales including pain, physical function and stiffness. Synavive is a novel dissociated glucocorticoid product candidate designed to enhance the anti-inflammatory benefits of glucocorticoids, without associated side effects. Synavive contains the cardiovascular agent dipyridamole and a very low dose of the glucocorticoid prednisolone and is being developed as a uniquely engineered oral, once-daily formulation.
In addition to maintaining efficacy for the Synavive-treatment group, placebo-treated subjects in the core study also experienced statistically significant improvements in all WOMAC measurement subscales upon crossing over to Synavive in the extension trial. Importantly, no treatment-related increase in glucocorticoid associated adverse events were observed in Synavive-treated subjects.
“Synavive appears to be well-tolerated and efficacious in reducing the signs and symptoms of knee OA over a 3 to 12-month period,” said Robert Forrester, Interim President and CEO of CombinatoRx. “These findings support the knee OA core study results and supplement the positive hand OA core study data, providing an attractive risk/benefit ratio warranting further development of Synavive in inflammatory conditions such as osteoarthritis and rheumatoid arthritis”.
SOURCE CombinatoRx, Incorporated
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