CrystalGenomics, Inc., a biopharmaceutical company headquartered in Korea, has just announced positive results from the Phase 2b osteoarthritis (OA) study of the CG100649, CrystalGenomics' next-generation NSAID candidate. The study met its primary and secondary endpoints which were to evaluate the safety, analgesic efficacy and functional benefits of CG100649 (2 mg or 4 mg per day) versus Celebrex® (celecoxib) (200 mg per day) over the 4 week treatment period.
This Phase 2b study was a double-blind, randomized, multicenter, non-inferiority, repeat dose study of CG100649 versus Celebrex in OA patients. Following a 5-14 day washout from all prior pain medications except paracetamol (acetaminophen), subjects recording moderate to severe hip or knee OA pain of 4 to 8 on a 0-10 numerical rating scale were randomized into the study. All subjects received 28 daily doses of either CG100649 2 mg or 4 mg, or Celebrex 200 mg. Anti-arthritic efficacy was evaluated using the standardized WOMAC OA Index and the WOMAC subscales of pain, stiffness, and physical function. The primary efficacy outcome was determined by measuring the change in the average WOMAC-Pain subscale in the index joint at Day 28 vs. Baseline. Secondary efficacy outcomes included the change in the 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. 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 (SAEs) in either of the CG100649 treatment groups or in the Celebrex treatment group. Similar non-serious adverse events (AEs) were observed in the CG100649 and Celebrex 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.
Dr. William Schmidt, Vice President of Clinical Development, said, "The two higher doses of CG100649 used in this study 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."
Dr. Joong Myung Cho, President & CEO of CrystalGenomics, stated, "This is an important milestone for CrystalGenomics and OA patients worldwide as we were successful in generating very exciting safety and efficacy data against Celebrex. 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."