CRP has been used as a clinical biomarker of diseases with an inflammatory component, such as cardiovascular disease, Crohn's disease, rheumatoid arthritis and end-stage renal disease.
Although CRP's active participation in these diseases remains to be determined, several lines of evidence support a causal role of CRP in disease, suggesting that it may be therapeutically beneficial to decrease CRP levels in patients who are at risk.
Isis Pharmaceuticals has announced it has initiated a Phase 1 study of ISIS 353512, an antisense drug that inhibits the production of C-reactive protein (CRP). In preclinical studies, ISIS 353512 produced dramatic suppression of liver and serum CRP levels. The Phase 1 study of ISIS 353512 is a blinded, randomized, placebo-controlled, dose-escalation study designed to assess the safety and pharmacokinetic profile of ISIS 353512 as well as to assess the initial effects of the drug on baseline CRP levels in healthy volunteers.
In addition, Isis is designing a broad Phase 2 program to investigate multiple indications for ISIS 353512.
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