Taking homework seriously
Despite having top-line Phase IIa data in hand showing efficacy for its NSAID in osteoarthritis, CrystalGenomics Inc.'s CG Pharmaceuticals Inc. unit is not rushing to get to Phase III. Instead, it is fleshing out its early stage development program, including an additional Phase I study against active comparators, with the aim of proving to FDA that the compound will avoid the cardiovascular risks associated with COX-2 inhibition.
FDA's Arthritis Advisory Committee made clear in its review of Merck & Co. Inc.'s Arcoxia COX-2 inhibitor that new NSAIDs should be superior in some way to approved NSAIDs(see BioCentury, April 16, 2007).
CG says its discussions with former regulators lead it to believe a robust early stage safety program including