Creabilis SA, a European biotechnology company specialising in the development of treatments for dermatology, inflammation and pain, has initiated the phase IIb global clinical trial of its lead product CT327 in patients with 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 which allow high local concentrations combined with low systemic exposure; these are ideal characteristics for medicines designed for topical applications.

The phase II b 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 II a 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 II b 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.”