CrystalGenomics to Present Preliminary Results from Recently Completed Supra-threshold Phase I MAD Study for CG100649, its Novel NSAID Candidate at the Arrowhead 4th Annual Pain Therapeutics Summit
CG100649 is a first-in-class NSAID drug candidate with a new "tissue-selective" mechanism of action which is designed to deliver sustained levels of drug to inflamed tissues, while maintaining low systemic exposure, by binding to carbonic anhydrase (CA) in red blood cells and being transported through the body in a protected-inactive state, then by being released into inflamed tissues which have little or no CA binding activity. Its unique dual COX-2 and CA binding properties are designed to provide potentially superior safety to cardiovascular, renal, and gastrointestinal tissues than approved NSAIDs or COX-2 inhibitor drugs.
As previously announced, a Phase IIa osteoarthritis trial was successfully completed in Europe with 248 patients. The efficacy and safety results were very favorable and these data showed that CG100649's efficacy profile is at least as favorable as other COX-2 drugs. This prompted CrystalGenomics to conduct a supra-threshold Phase I Multiple Ascending Dose (MAD) study to explore higher doses of CG100649 in pharmacokinetic and pharmacodynamic tests prior to initiating a Phase IIb efficacy study. Based on clinical data collected so far, it is anticipated that CG100649 should achieve significant safety as well as even higher levels of efficacy at higher doses.
The Phase I MAD study evaluated doses up to 6.7 times higher than the established efficacious dose from the Phase IIa OA study and, successfully enrolled and dosed all subjects in 3 cohorts without any Serious Adverse Events related to the study medication. CrystalGenomics will present the preliminary data at the Arrowhead Pain Therapeutics Summit on October 5, 2010.
Joong Myung Cho, President & CEO of CrystalGenomics said: "We are very pleased with the preliminary results and this will enable us to begin the Phase IIb study with a high level of confidence about our drug's safety even at much higher doses."
SOURCE CrystalGenomics, Inc.