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Creabilis Announces Positive Phase IIa Results for TrkA Kinase Inhibitor CT327 in Psoriasis Vulgaris

March 10, 2011

LUXEMBOURG, March 10, 2011 /PRNewswire/ — 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.

About Creabilis SA

Creabilis is a clinical-stage European biotechnology company creating
innovative new drugs to tackle unmet medical needs in dermatology. Bringing
together world class drug development capabilities and a rich scientific
heritage, Creabilis is uniquely positioned to transform the treatment of skin
diseases.

Creabilis’ lead product is CT327 a novel topically applied TrkA kinase
inhibitor developed using the Company’s 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). CT327 is currently in Phase II clinical
development in psoriasis and atopic dermatitis and is undergoing
proof-of-concept studies in pain. The Creabilis portfolio also includes
CT637, a new approach to the treatment of significant inflammatory
conditions. Earlier-stage projects include a number of highly promising
candidates for dermatological and wider indications.

Creabilis is backed by some of Europe’s most highly respected life
sciences investors including Sofinnova Partners and Neomed.

    For more information, please visit: http://www.creabilis-sa.com

    For further information please contact:

    Creabilis
    Eliot Forster
    eforster@creabilis-sa.com
    Creabilis SA
    5 rue Jean Monnet L-2810 LUXEMBOURG

    CitigateDeweRogerson
    Chris Gardner or Nina Enegren
    Tel: +44(0)20-7282-1050
    E-mail: nina.enegren@citigatedr.co.uk

SOURCE Creabilis SA


Source: newswire



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