The Seoul, South Korea-based biopharmaceutical company CrystalGenomics, Inc, recently announced positive results from its phase 2b osteoarthritis (OA) study of CG100649, which the company characterizes as its next-generation NSAID candidate. Researchers report that the study successfully met its primary and secondary endpoints to evaluate safety, analgesic efficacy, and functional benefits of a 2-milligram or 4-milligram daily dose of CG100649 compared to a 200-milligram daily dose of Celebrex (celecoxib) in OA patients over a 4-week treatment period.
According a news release, after a 5-day to 14-day washout from prior medications with the exception of acetaminophen, patients who reported moderate to severe hip or knee OA pain of 4 to 8 on a 0-10 medical rating scale were randomized into the study. Researchers report that all patients were treated with 2-milligram or 4-milligram daily doses of CG100649 or a 200-milligram dose of Celebrex.
The study notes that the treatments’ anti-arthritic efficacy was evaluated using the standardized WOMAC OA Index and the WOMAC subscales of pain, stiffness, and physical function. Researchers add that they measured the change in the average WOMAC-Pain subscale in the index joint at day 28 and compared the results to those exhibited at baseline in order to determine the study’s primary efficacy outcome. The secondary efficacy outcomes included changes in the average WOMAC Pain at days 7, 14, 21, 35, and 42, changes in the total WOMAC OA Index at days 14, 28, and 42, changes in the WOMAC Stiffness & Physical Function subscales at days 14, 28, and 42, and Subject’s Global Assessment and Physician’s Global Assessment of OA pain at days 1, 14, 28, and 42. The results also suggest that during the study, both CG100649 treatment groups exhibited non-inferiority in primary and secondary outcome measures compared to Celebrex. Researchers report that no drug-related serious adverse events (SAEs) were observed in either of the CG100649 groups or in the Celebrex treatment groups and similar non-serious adverse events (AEs) were observed in both treatment groups.
William Schmidt, PhD, CrystalGenomics vice president of clinical development, explains the importance of the two higher doses of CG100649, which, ”complete the pre-planned phase 2 dose-ranging phase for CG100649 and allow us to select a dose for the phase 3 study that will be initiated later this year.”
Joong Myung Cho, PhD, CrystalGenomics president and CEO, adds that the study marks an important milestone for the company and OA patients, “The positive results from this phase 2b study will strengthen CG100649’s position of becoming the next generation NSAID for treating pain and other OA symptoms in patients with moderate to severe OA,” Cho says.