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  • 12 January 2015
    Creabilis Receives Positive Feedback on CT327 from US FDA, Providing Clear Path to Registration

    Creabilis Ltd, the dermatology company with the most advanced targeted topical treatment in development for chronic pruritus (itch), announces that it has received positive feedback from the US Food and Drug Administration (FDA) on its lead product CT327. Creabilis will now make the final preparations to advance CT327, its novel topical targeted treatment for peripheral pruritus into a pivotal Phase III development program to address pruritus due to psoriasis.

    In the meeting the FDA examined the positive data already reported with the Company’s lead product CT327, a first-in-class TrkA kinase inhibitor for the treatment of pruritus (itch) of psoriasis. In the FDA’s meeting minutes, the importance of pruritus due to psoriasis was acknowledged as an indication in its own right due to the fact that no treatment is currently labelled for this common condition. This outcome is in line with successful meetings already held with the MHRA and MEB and Creabilis believes defines the clearest route to registration.

    Creabilis is now preparing to initiate its Phase III development program for CT327 and has already initiated partnering discussions for this unique treatment.