LUXEMBOURG, December 15, 2010 /PRNewswire/ -- Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, today announced positive results in the Phase IIa study of its lead product CT327 in atopic dermatitis.
CT327 is a novel topically applied TrkA kinase inhibitor developed using the Creabilis' LSE (Low Systemic Exposure) technology. LSE technology creates new chemical entities with ideal characteristics for topical application (high local concentrations combined with low systemic exposure).
In the pilot efficacy study conducted in Switzerland, 15 atopic dermatitis patients (AD) were recruited, with eight treated topically with 0.1% CT327 [cream] twice daily for 15 days and seven receiving placebo. A clinically significant improvement in symptoms was seen after eight days of treatment with CT327 as measured by change in mEASI (modified eczema area and severity index) score from baseline. Onset of efficacy was seen at three to five days of treatment. The greatest patient-reported benefit was in night time itch, one of the most troublesome symptoms of atopic dermatitis.
CT327 was shown to be safe and well tolerated with no serious adverse events and no reported site irritation.
Commenting on the results, Prof. Jonathan Barker from St. John's Institute of Dermatology at King's College, London, said: "There is a real need for truly novel new treatments in dermatology and while these are very early stage results it is exciting to see progress being made with an entirely new approach to the treatment of AD and other serious skin conditions."
Dr Eliot Forster CEO of Creabilis said: "These early clinical data are very encouraging. While only a pilot study these data in patients begin to confirm the promise of CT327 seen in our pre-clinical work where the product has demonstrated antiproliferative activity on keratinocytes and effectiveness in hyperproliferative skin disease models."
CT327 is also currently in Phase IIa proof-of-concept clinical trials in psoriasis and pain. Further proof-of-concept clinical trials in inflammatory pain are planned.