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news.Isis Pharmaceuticals has initiated a Phase I study of ISIS 353512, an antisense drug that inhibits the production of C-reactive protein.
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C-reactive protein (CRP) levels are frequently elevated in patients with a variety of diseases including cardiovascular disease, Crohn’s disease, rheumatoid arthritis and end-stage renal disease.
The Phase I 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 II program to investigate multiple indications for ISIS 353512.
Stanley Crooke, chairman and CEO of Isis, said: “We believe that CRP plays an important causal role not only in cardiovascular disease but also in renal and inflammatory diseases. Based on our preclinical data, and the safety and pharmacological data we will obtain from this study, we plan to create a Phase II development plan that evaluates several of the most scientifically and commercially attractive indications for ISIS 353512.”