Isis Pharma Announces Data From Phase 2 Study Of Isis-CRP Rx In Patients With RA

(RTTNews) - Isis Pharmaceuticals Inc. (ISIS) announced that patients treated with ISIS-CRPRx achieved rapid, dose-dependent mean reductions of up to 67 percent in C-reactive protein or CRP in a Phase 2 study in patients with rheumatoid arthritis or RA.

The company said that patients treated with ISIS-CRPRx showed improvements in signs and symptoms of RA; however, these improvements were not statistically significant when compared to those observed in patients in the placebo group, which demonstrated a higher than expected response in both symptom score and CRP reduction. A Phase 2 study of ISIS-CRPRx in patients with atrial fibrillation is currently ongoing with data anticipated in the first half of 2014.

"While we do not plan to further develop ISIS-CRPRx for RA, we do plan to continue to evaluate ISIS-CRPRx to treat other diseases," said Richard Geary, senior vice president of development at Isis.

The Phase 2 study was a randomized, placebo-controlled, multiple-dose study in patients with RA who had chronically elevated CRP. In this study, 51 patients received 100 mg, 200 mg or 400 mg dose of ISIS-CRPRx or placebo for 12 weeks. Patients in the study treated with ISIS-CRPRx achieved substantial, dose-dependent reductions in CRP early in treatment that were prolonged through the treatment process.

The company noted that patients also experienced improvements in the signs and symptoms of RA, as measured by ACR20 and ACR50 scores. These improvements correlated with reductions in CRP, but were not sufficiently greater than improvements observed in the placebo groups to justify further development of ISIS-CRPRx for RA.