Mar 10 2011
Creabilis SA, a clinical stage European biotechnology company addressing unmet medical needs in dermatology, today announced positive results from its Phase IIa study of its lead product CT327 in psoriasis vulgaris.
CT327 is a novel topically applied TrkA kinase inhibitor developed using 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).
The proof-of-concept study was conducted in the USA and Europe in Psoriasis patients who were treated for an eight-week period. Forty-eight patients were treated topically with 0.1%w/w CT327 cream twice daily and nine patients treated with matching placebo. CT327produced a good efficacy response across multiple endpoints including PGA (Physician Global Assessment) and mPASI(modified Psoriasis Area and Severity Index). In the PGA analysis, 33% of patients had "controlled disease" at the end of the 8 weeks treatment period compared to 8% at the start of the study and the number of 'severe or very severe' patients was reduced by 50% over the same period. For placebo,7% of patients had "controlled disease" at the end of the study compared to 6% at the start.
CT327 was well tolerated with no reported application site irritation. A pharmacokinetic analysis at day 56 showed there to be no measurable plasma CT327, as anticipated with the LSE technology and consistent with Phase I and pre-clinical studies.
Dr Eliot Forster CEO of Creabilis said: "The positive data reported today from our Phase IIa study are very promising. While an early stage study, we have seen good evidence of efficacy across multiple endpoints and, importantly, in PGA, the FDA's required endpoint for psoriasis. We believe our new formulation and optimised, higher, dosing will create class leading attributes for CT327. More broadly, the study provides further evidence of the potential of our LSE technology in topical drug delivery."
Prof. Jonathan Barker from St. John's Institute of Dermatology at King's College London, said: "This is an impressive set of results and provides real encouragement for the further development of a product candidate that offers an entirely new approach to the treatment of psoriasis and other serious skin conditions."
CT327 reported positive results from a Phase IIa study in atopic dermatitis late last year and further proof-of-concept clinical trials in pain are ongoing.
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