COMBINATORX ANNOUNCES RESULTS FROM RHEUMATOID ARTHRITIS STUDY

CombinatoRx has announced positive preliminary results from its randomized, blinded, placebo-controlled Phase II clinical trial of CRx-102 in rheumatoid arthritis (RA). The trial compared CRx-102 plus a disease-modifying anti-rheumatic drug (DMARD) with placebo plus DMARD in subjects with RA. In this trial, CRx-102 demonstrated statistically significant improvements on primary and secondary endpoints.

This trial was a multicenter, blinded, placebo-controlled, randomized study. The primary endpoint was reduction in C-reactive protein (CRP) levels comparing CRx-102 plus DMARD to placebo plus DMARD from baseline at day 42. Secondary endpoints of the trial included American College of Rheumatology (ACR) 20 responses and Disease Activity Score using 28 joint counts (DAS 28). Data provided are per the protocol; statistical significance remains consistent in the intent-to-treat population. Other secondary endpoints are being analyzed and will be presented at appropriate scientific venues.

Fifty-nine patients were enrolled in this study with established rheumatoid arthritis and moderate disease activity as determined by DAS 28 scores of greater than 4.5 and CRP levels of greater than 2.2 mg/L. Patients had to be on a DMARD therapy (such as methotrexate or sulfasalazine) for at least three months and be on a stable dose of DMARD therapy for a minimum of 28 days prior to enrollment. CRx-102 was dosed in this trial using 3 mg of prednisolone and two different doses of dipyridamole. Patients received the first ratio for the first week of treatment and the second ratio for the following five weeks.

CRx-102 is an oral synergistic combination drug candidate containing the cardiovascular agent dipyridamole and an unconventionally low dose (3 mg) of the steroid prednisolone. The drug works through a novel mechanism of action in which dipyridamole selectively amplifies prednisolone's anti-inflammatory and immunomodulatory activities without replicating its side effects.