Creabilis, a European biotechnology company specializing in dermatology, inflammation and pain, has initiated a phase IIb global clinical trial of its lead product CT327 in patients with psoriasis vulgaris.
The phase IIb study is a randomized, 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.
CT327 is a novel topically applied TrkA kinase inhibitor developed using Creabilis' low systemic exposure (LSE) 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.
Results from Creabilis’ phase IIa study of CT327 in psoriasis, released in March 2011, showed that CT327 (0.1% w/w cream formulation) produced a good efficacy response across multiple endpoints including 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.
"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,” said Dr. David Roblin, chief medical officer of Creabilis. “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."