Isis Pharmaceuticals Reports That Its Selective CRP Inhibitor Demonstrated Activity in a Phase 1 Study
CARLSBAD, Calif., Feb. 23, 2011 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) announced today the results from a Phase 1 clinical trial in which ISIS-CRPRx produced statistically significant reductions in C-reactive protein (CRP) in the cohort of subjects in the study with elevated CRP. In this study, ISIS-CRPRx was well tolerated at doses up to 600 mg/week. Isis plans to evaluate ISIS-CRPRx in Phase 2 studies in indications that could provide early proof-of-concept in diseases with elevated CRP. Isis plans to initially evaluate ISIS-CRPRx in multiple myeloma and rheumatoid arthritis, before expanding into cardiovascular and other diseases.
"CRP levels are increased in many inflammatory disorders, and excessive amounts of CRP have been linked to multiple clinical conditions, including cardiovascular disease and diabetes," said Paul M. Ridker, M.D., Eugene Braunwald Professor of Medicine at the Brigham and Women's Hospital and Harvard Medical School. "This is the first evaluation of a selective CRP inhibitor and the first such drug shown to be active in man. What this new agent thus provides is a method to directly test whether or not lowering CRP per se might be beneficial for patient care, something that could not be addressed in the past."
The Phase 1 study of ISIS-CRPRx was a blinded, randomized, placebo-controlled, dose-escalation study designed to assess the safety and pharmacokinetic profile of ISIS-CRPRx as well as to assess the initial effects of the drug on baseline CRP levels. ISIS-CRPRx was evaluated in single and multiple doses ranging from 50 mg per week to 600 mg per week in 80 healthy volunteers. In all but one cohort, Isis enrolled subjects who had normal (generally undetectable to less than 2 mg/L) CRP levels. In the 600 mg per week multi-dose cohort, Isis enrolled eight subjec