CombinatoRx has announced positive top line results from a randomized, blinded, placebo-controlled, Phase II proof-of-concept clinical trial of CRx-191 in plaque psoriasis.
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The trial evaluated the efficacy, safety and tolerability of two doses of CRx-191 compared to placebo in subjects with psoriasis. In this trial, the high dose of CRx-191 demonstrated an 81% reduction in psoriatic infiltrate from baseline to day 12, compared to 11% for placebo. This reduction demonstrated with CRx-191 was statistically significant (P<0.0001). Similarly, CRx-191 demonstrated a 58% reduction in erythema (redness) from baseline to day 12, as compared to 6% with placebo. This effect was also statistically significant (P<0.0001). In clinical assessments of skin condition, CRx-191 demonstrated clinically significant improvements from baseline to day 12 in 100% of all test fields, as compared to 0% for placebo. The high and low doses of CRx-191 performed similarly, although CRx-191 high dose was numerically superior to low dose on most measures. CRx-191 was well tolerated and there were no adverse events reported for any subjects treated in this trial.
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