Date: 2013-05-10
Type of information:
phase: 2b
Announcement: results
Company: Creabilis (Luxembourg)
Product: CT327 (TrkA kinase inhibitor )
Action
mechanism: 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.
Disease: psoriasis vulgaris
Therapeutic area: Autoimmune diseases – Dermatological diseases
Country:
Trial details: 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. One hundred and sixty patients with mild to moderate psoriasis were recruited. The study endpoints were IGA (Investigator Global Assessment), pruritus (VAS), mPASI and adverse event reports.
Latest
news: * On May 10, 2013, Creabilis, a late stage European dermatology company with a focus on chronic pruritus (itch), has announced headline results of its Phase 2b trial with its lead product, CT327, in psoriasis patients. Chronic pruritus is a debilitating symptom of many dermatological diseases and has a significant impact on quality of life, including sleep. It is the cardinal symptom in atopic dermatitis and a key symptom of psoriasis.Patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded placebo vehicle. Pruritus was measured using a visual analogue scale (VAS), the accepted regulatory endpoint. The reduction from baseline in pruritus VAS reached 60% for CT327 compared to 20% for vehicle alone (p 40mm).An improvement was also seen in the CT327 treated groups versus vehicle in mPASI (modified Psoriasis Area and Severity Index) in all patients. In patients with at least moderate pruritus at the start of the trial, significant reductions in mPASI were observed for CT327 compared to vehicle. There was no significant impact of any dose of CT327 on the IGA (Investigator Global Assessment) endpoint.CT327 was safe and well tolerated with no site application reactions and no systemic exposure. Notably, patients on CT327 reported fewer adverse events and withdrawals due to pruritus than the vehicle treated patients.Full data are expected to be presented at a scientific meeting later in 2013.* On February 29, 2012, Creabilis has announced the start of the Phase IIb global clinical trial of its lead product CT327 in patients with psoriasis vulgaris. A total of 160 patients are expected to complete the trial and results are anticipated towards the end of 2012.
