application): The treatment and prevention of the debilitating symptoms of inflammatory bowel disease (IBD) represents a major unmet medical need. This proposal is for support of Phase II studies to further develop Centaur's lead IBD candidate. During the period of the Phase I grant the chemical structure of the lead candidate, CPI-1189 was optimized in order to improve its efficacy characteristics in an in vivo rat model of IBD while maintaining its high oral bioavailability and pharmacokinetic (PK) profile. From these studies a new lead compound, C203, was developed; this compound appears to have twice the efficacy of CPI-1189. In the present Phase II application, additional efficacy and mechanism studies are proposed to develop a pharmacology package for inclusion in a US IND for C203. Also planned are bulk drug production, and pilot safety and PK studies to support 28-day GLP toxicity studies with C203 in the rat and dog. These activities will all support an IND filing. The present proposal is a revision of a previous application for Phase II funding.
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