( 39 (containing 10or 20mg paroxetine wi...)CombinatoRx Provides Topline Results from Phase 2 RA Study with,CRx-139 and Very Low Dose Prednisolone,Health

39 (containing 10 or 20mg paroxetine with prednisolone) and 3mg of prednisolone in a 1:1:1 ratio in subjects with active RA who were on stable disease modifying anti-rheumatic drug (DMARD) therapies. The primary endpoint was ACR 20 response at day 70. Other endpoints of the trial included ACR 50 and ACR 70 responses and DAS28 scores. Additional endpoints are being analyzed and will be presented at appropriate scientific venues.

209 patients with established RA and moderate to severe disease activity with greater than6 tender and greater than4 swollen joints were enrolled in this study. Patients had to be on a DMARD therapy (such as methotrexate or sulfasalazine) for at least 3 months and be on a stable dose of DMARD therapy for a minimum of 1 month (2 months for methotrexate) prior to enrollment. CRx-139 was dosed in this trial using 3mg of prednisolone and two different doses of paroxetine. All patients received 3mg of prednisolone alone during the first 2 weeks (baseline) and then were randomized to also receive either 10mg or 20mg of paroxetine or placebo for the following 8 weeks (combination treatment period). Each arm was then deconvoluted into the individual components (3mg of prednisolone and 10 or 20mg of paroxetine or 3mg prednisolone and placebo alone) for the remaining 4 weeks (withdrawal period).

The ACR 20 score is a standard measure developed by the American College of Rheumatology to rate RA disease improvement. Patients are classified as ACR 20 responders if they demonstrate a 20% improvement from baseline in tender and swollen joint count and at least 3 of 5 other symptom related criteria. The Disease Activity Score using 28 joint counts (DAS28) is a composite score used to monitor disease activity in RA patients.

Conference Call Information

CombinatoRx management will host a conference call to discuss these results at 5:30 p.m. ET on Monday, March 26, 2007. To access the call, please dial 800-706-7745 (domestic) or 617-
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