The CG100649 treatment group met the primary efficacy endpoint by demonstrating a clinically and statistically significant change in the WOMAC osteoarthritis (OA) score from baseline to day 21 (p=0.010) compared to placebo.
The study also met all key secondary endpoints, with the high dose demonstrating clinically and statistically significant superiority in the WOMAC OA score over the entire 21-day active treatment period (p=0.009) and in the WOMAC subscales of pain, stiffness and physical function (p=0.016, p=0.023, p=0.010, respectively) over the entire 35-day treatment and follow-up evaluation periods.
Weekly pain relief scores showed statistically significant improvements at days seven, 14, 21, and 28 (p<0.05 at all time periods) which demonstrated that CG100649 had an early onset of activity and provided sustained treatment benefits over the entire treatment period.
On the primary endpoint of change in the WOMAC score from baseline to day 21, the high dose of CG100649 showed more than a two-fold greater magnitude of improvement than the placebo group (median values were 37% versus 17%, respectively).
The CG100649 high dose was shown to be superior to placebo on the primary and secondary efficacy endpoints measured in sum of the WOMAC OA index, and its subscales of pain, stiffness, and physical function.
CG100649’s beneficial results were also demonstrated on secondary endpoints using the well-established brief pain inventory. Both the medium and high doses of CG100649 showed clinically and statistically significant improvement in average and worst daily pain intensity (DPI) scores over the entire 21-day active treatment period compared to final three days of washout period, the company said.
Joong Myung Cho, president and CEO of CrystalGenomics, said: Based on these results, we are confident that CG100649 can fulfill the current unmet medical need for an efficacious analgesic and anti-inflammatory agent with potential cardiovascular, renal, and gastrointestinal safety advantages over currently available treatments.