Headline results of Creabilis' CT327 Phase 2b trial in psoriasis patients announced

May 10 2013

Clinically and Statistically Significant Reduction of Chronic Pruritus (Itch) Seen in Psoriasis Patients

Creabilis, a late stage European dermatology company with a focus on chronic pruritus (itch), today announces headline results of its Phase 2b trial with its lead product, CT327, in psoriasis patients. CT327 is a novel, topical, TrkA kinase inhibitor developed using Creabilis' LSE (Low Systemic Exposure) technology that creates 'topical-by-design' drugs.

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. No medicine is currently approved for chronic pruritus.

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<0.05). A clinically meaningful reduction in pruritus (VAS ≥ 20mm) was seen in up to 79% of patients for CT327 compared to 36% for vehicle alone (p<0.05).  At baseline, 69% of patients reported at least moderate pruritus (VAS > 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.

SOURCE Creabilis SA