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Isis Pharmaceuticals halts developing experimental drug for RA patients

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Isis Pharmaceuticals has announced it will discontinue development of its experimental drug to treat patients with rheumatoid arthritis following the results of a phase 2 study.

Patients with rheumatoid arthritis (RA), who were treated with the antisense drug ISIS-CRP_RX, achieved rapid, dose-dependent mean reductions up to 67% in C-reactive protein (CRP) in the study. Improvements, however, were not statistically significant compared with a placebo-treated group, according to a press release.

Researchers studied 51 patients with RA who had chronically elevated CRP. The patients were randomly assigned 100 mg, 200 mg or 400 mg ISIS-CRP_RX or placebo for 12 weeks. Treated patients achieved substantial, dose-dependent reductions in CRP early in treatment, which was maintained, according to the release. American College of Rheumatology 20% response (ACR20) and ACR50 scores also measured improved signs and symptoms of RA, which correlated with the CRP reductions, but were not statistically greater than those of placebo patients.

“By treating patients with chronically elevated CRP with ISIS-CRP_RX, we hoped to accomplish three things: to confirm in patients the substantial CRP-lowering activity we observed in our earlier clinical studies, to gain additional experience with the drug before testing it in more severe indications, and to evaluate whether lowering CRP correlates with an improvement in RA symptoms,” Richard Geary, PhD, senior vice president of development at Isis, said in the press release. “The study accomplished its goals … but we are disappointed that we did not see a greater impact on RA symptoms in these patients.

“While we do not plan to further develop ISIS-CRP_RX for RA, we do plan to continue to evaluate ISIS-CRP_RX to treat other diseases.”

A phase 2 study of the drug in patients with atrial fibrillation is ongoing, and study data is anticipated in the first half of 2014, according to the release.