LUXEMBOURG, February 29, 2012 /PRNewswire/ --
Creabilis SA, a European biotechnology company specialising in the development of treatments for dermatology, inflammation and pain, today announced the start of the Phase IIb global clinical trial of its lead product CT327 in patients with psoriasis vulgaris. Recruitment is progressing well.
CT327 is a novel topically applied TrkA kinase inhibitor developed using Creabilis' LSE (Low Systemic Exposure) technology. LSE technology creates new chemical entities which allow high local concentrations combined with low systemic exposure; these are ideal characteristics for medicines designed for topical applications.
The Phase IIb study is a randomised, double-blind, placebo controlled dose finding study of the efficacy and safety of a new CT327 ointment formulation (0.05%, 0.1% and 0.5% w/w) administered for up to eight weeks in patients with psoriasis. A total of 160 patients are expected to complete the trial and results are anticipated towards the end of 2012.
Creabilis announced positive results from a Phase IIa study of CT327 in psoriasis in March 2011. CT327 (0.1% w/w cream formulation) produced a good efficacy response across multiple endpoints including PGA (Physician Global Assessment) and mPASI (modified Psoriasis Area and Severity Index). CT327 was also well tolerated with no reported application site irritation. Pharmacokinetic analysis showed no detectable plasma CT327, as anticipated with the LSE technology.
Dr David Roblin, Chief Medical Officer of Creabilis said: "Our Phase IIb trial of CT327 is another important step in the development of a product that we believe has exciting potential in the treatment of psoriasis and other important skin diseases. This study uses the new and proposed commercial ointment formulation and in three concentrations of CT327 to ensure that the best dose is selected for Phase III start. We look forward to building on the very promising Phase IIa results already generated."
About Creabilis SA
Creabilis is a clinical-stage European biotechnology company creating innovative new drugs to tackle unmet medical needs in dermatology and inflammatory diseases. Bringing together world class drug development capabilities and a rich scientific heritage, Creabilis is uniquely positioned to transform the treatment of its target diseases.
Creabilis' lead product is CT327, a novel topically applied TrkA kinase inhibitor developed using the Company's Low Systemic Exposure (LSE) technology. CT327 is currently in Phase II clinical trials in psoriasis and atopic dermatitis and is undergoing proof-of-concept studies in pain. CT340 is a potent TrkA kinase inhibitor under development for the treatment of conditions in which TrkA kinase inhibition is indicated, including inflammatory arthritis and pain. The Creabilis portfolio also includes CT637, an HMGB1 antagonist and a novel 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, Neomed and Abbott Biotech Ventures, Inc.
For more information, please visit: http://www.creabilis-sa.com
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SOURCE Creabilis SA