CombinatoRx (CRXX) Announces Positive Phase 2 Results in Clinical Trial of CRx-191
CombinatoRx, Incorporated (NASDAQ: CRXX) announced top line results of its randomized, blinded, placebo-controlled Phase 2 proof-of-concept clinical trial of CRx-191 in plaque psoriasis. CRx-191 is a topical synergistic combination drug candidate in development for psoriasis and other steroid-responsive dermatoses. 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.
CRx-191 was also compared to its individual components on multiple measures such as psoriatic infiltrate thickness, erythema and clinical skin condition and produced greater improvements than mometasone and nortriptyline alone. Although this trial was not powered to achieve statistical significance in comparison to its components, CRx-191 was superior in all aspects and achieved statistical significance for erythema. The mean reduction in erythema for CRx-191 compared to mometasone was statistically significant (P=0.017) and numerically greater on infiltrate thickness reduction and clinical skin assessment scores. CRx-191 induced statistically significant reductions compared with nortriptyline on infiltrate thickness (P<0.0001) and erythema (P<0.0001), and improved clinical skin assessment scores compared with nortriptyline.
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