( nausea andthe anti-cholinergic side e...)CombinatoRx Product Candidate CRx-150 Shows Activity on DAS28 and,Pain, but Not CRP,Health

"While we're pleased to see that this novel synergistic combination has demonstrated some clinical effect, it does not meet our target product profile and has been discontinued as a development program," commented Alexis Borisy, President and CEO of CombinatoRx. "The level of activity observed with CRx-150 would not be competitive within the CombinatoRx product portfolio or the RA marketplace, as our lead RA product candidate, CRx-102, has demonstrated a much stronger clinical profile to date. We look forward to providing an update on the CombinatoRx pipeline including CRx-102, CRx-191 and CRx-401 among others at our R&D Day event in Cambridge on July 24th."

About CRx-150

CRx-150 is a novel synergistic cytokine modulator comprised of the antidepressant amoxapine and the cardiovascular drug dipyridamole, neither of which is indicated for the treatment of immuno-inflammatory disease on its own, but which have been shown in both preclinical and human inflammatory biomarker studies to act synergistically to modulate cytokine production.

About the Trial Design

This trial was a multi-center, blinded, randomized study evaluating the effectiveness of CRx-150 plus DMARD therapy compared to placebo plus DMARD in a 2:1 ratio in subjects with RA. The primary endpoint was reduction in CRP levels comparing CRx-150 plus DMARD to placebo plus DMARD from baseline at day 42. Secondary endpoints of the study included DAS28 scores, ACR 20 responses and changes in inflammatory cytokines from baseline to day 42.

64 subjects with established RA and moderate disease activity with greater than or equal to 6 tender and greater than or equal to 5 swollen joints were enrolled in this study. Patients had to be on DMARD therapy (such as methotrexate or sulfasalazine) for at least 3 months and be on a stable dose of DMARD therapy for a
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