Positive results in Phase IIb study of CG100649 (CrystalGenomics) for Osteoarthritis

A Phase IIb study of the CG100649, from CrystalGenomics, shows the candidate drug for Osteoarthritis met its primary and secondary endpoints in an evaluation of the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex (celecoxib) (200 mg per day) over a 4 week treatment period. Anti-arthritic efficacy was evaluated using the standardized WOMAC OA Index and the WOMAC subscales of pain, stiffness, and physical function. Throughout the study, both of the CG100649 treatment groups demonstrated non-inferiority compared to Celebrex on all primary and secondary outcome measures. There were no drug-related serious adverse events in either of the CG100649 treatment groups or in the Celebrex treatment group. Similar non-serious adverse events were observed in both treatment groups. Although a long-term cardiovascular safety profile could not be established by this short-term study, there were no indications that CG100649 had a negative impact on heart function, ECG profiles, or blood pressure. The study has allowed the company to select a dose for the Phase III study that will be initiated later this year.