AsianScientist (Jun. 1, 2011) – CrystalGenomics, Inc. (Seoul, Korea) and CG Pharmaceuticals, Inc. (Emeryville, California) have enrolled the first patient for a Phase IIb clinical study of CG100649, a novel NSAID candidate for patients with knee or hip osteoarthritis (OA).
CG100649 is a first-in-class NSAID drug candidate that is a dual inhibitor of COX-2 and carbonic anhydrase (CA).
An earlier placebo-controlled Phase IIa efficacy study in hip and knee in 248 patients in Europe showed that a 1.2 mg daily dose provided a highly significant efficacy profile versus the three major symptoms of osteoarthritis: pain, stiffness, and physical disability.
Although this was not an active-comparator trial, the efficacy profile of CG100649 appeared to be at least as favorable as other COX-2 drugs. This prompted CrystalGenomics to conduct a supra-threshold Phase I Multiple Ascending Dose study in healthy subjects last year that showed that higher doses of CG100649 (2, 4, or 8 mg per day) are likely to provide even higher levels of efficacy while maintaining CG100649’s favorable safety profile.
The current Phase IIb study is a double-blind, randomized, multicenter, non-inferiority, repeat dose study of CG100649 versus celecoxib (Celebrex®) in OA patients. Celebrex® is a registered trademark of Pfizer, Inc.
In this Phase IIb study, only subjects recording average pain scores of 4 to 8 on a 0-10 numerical rating scale will be randomized into the study. Study participants will then receive 28 daily doses of either 2 mg/day or 4 mg/day of CG100649, or 200 mg/day of celecoxib. Anti-arthritic efficacy will be evaluated using the standardized Western Ontario and McMaster Universities (WOMAC) OA Index and the WOMAC subscales that measure pain, stiffness, and physical function.
“We hope that successful completion of this Phase IIb study will position CG100649 as the leader among the next generation of NSAIDs for treating pain and disability in patients with moderate-severe osteoarthritis,” said Dr. Joong Myung Cho, President & CEO of CrystalGenomics.
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Source: CG Pharmaceuticals Inc.
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