Isis Pharmaceuticals, Inc. announced it has initiated a Phase II clinical trial of ISIS 104838, an inhibitor of tumor necrosis factor-alpha (TNF-alpha), in rheumatoid arthritis (RA).
The Phase II clinical trial will evaluate the safety and efficacy of ISIS in RA when administered by subcutaneous injection (SQ) for three months. This is the second Phase II study of ISIS currently in progress.
TNF-alpha is a naturally occurring cytokine that is involved in the development and progression of many inflammatory diseases, including RA. The double-masked, placebo-controlled, randomized Phase II study is planned to enroll 160 people with RA at 25 sites in the U.S. and Canada.
Three dosing regimens will be examined in this study: ISIS injections twice a week, once a week or once every other week. The primary endpoint in the study is improvement in American College of Rheumatology (ACR) response criteria, which measures improvement in patient and professional reported disease severity and activity.
“We are pleased to begin the second study of ISIS in people with rheumatoid arthritis, and to move forward with the clinical development of our new generation of antisense drugs. The initial Phase II trial, which began last November, is studying ISIS drug concentrations in tissue and blood as well as the drug’s ability to reduce TNF-alpha levels. This new trial will be the first to provide efficacy information about ISIS in RA. We will use the combined results from the two studies to direct our future development plans with this drug,” said F. Andrew Dorr, M.D., Isis Vice President and Chief Medical Officer.
Isis’ first Phase II clinical trial of ISIS is evaluating the biological effect of TNF-alpha inhibition by ISIS in 20 RA patients over a four-week treatment period.
Phase I trials of intravenous infusion and SQ administration of ISIS demonstrated enhanced tolerability, duration of effect and dosing convenience compared with first-generation drugs.