March 19, 2015
Canterbury, UK – 19th March 2015 – Creabilis Ltd, the dermatology company with the most advanced targeted topical treatment in development for chronic pruritus (itch), announces today that it has published positive Phase 2b clinical data for its novel TrkA kinase inhibitor CT327 in Acta Dermato-Venereologica, one of the pre-eminent international peer-review journals in dermatology.
The paper outlines the data reported with the Company’s lead product CT327, a first-in-class selective TrkA kinase inhibitor for the treatment of pruritus (itch) due to psoriasis, a condition where there is no approved standard of care currently. In the multinational randomized, double-blind, vehicle-controlled Phase 2b trial, clinically and statistically-significant reductions (p=0.0067) in pruritus were seen in patients with mild to moderate pruritus treated with CT327.
This builds on previous work published by Creabilis in the Journal of the American Academy of Dermatology , which demonstrates a lack of correlation between psoriasis disease severity and pruritus severity, highlighting the need for targeted anti-pruritic treatments for patients with psoriasis and other dermatological conditions.
Chronic pruritus (itch) is a debilitating symptom of many dermatological diseases and has a significant impact on quality of life. Patients with chronic pruritus often have multiple episodes per day, scratch until bleeding, and are unable to sleep, resulting in broader socioeconomic and psychosocial problems for these patients, including impacts on school, work attendance, and depression. Pruritus is one of the most important symptoms of psoriasis. There is no medicine currently approved for the topical treatment of chronic pruritus. A recent study found no existing treatment relieved pruritus in 45% of psoriatics.
About Pruritus and CT327
CT327 inhibits the intracellular kinase of the TrkA receptor, the high affinity receptor for Nerve Growth Factor (NGF), and consequently reduces the peripheral sensitization of sensory neurons, a process that plays a pivotal role in the pathogenesis of pruritus.
About the Phase 2b Trial in Pruritus of Psoriasis
In a Phase 2b study of 160 psoriatic subjects designed to evaluate the safety and efficacy of CT327, patients receiving CT327 showed a statistically significant and clinically meaningful reduction in pruritus compared to blinded vehicle emollient. Pruritus was measured using a visual analogue scale (VAS), the accepted regulatory endpoint for pruritus. The reduction from baseline in pruritus VAS reached 60% for patients treated with CT327 compared to 20% for patients treated with vehicle (p<0.05). Up to 62% of patients treated with CT327 achieved at least a 50% reduction in pruritus VAS compared to 32% of patients on vehicle (p<0.05). At baseline, 69% of CT327 treated patients had none or mild pruritus by end of therapy (VAS > 40mm). CT327 was safe and well tolerated, with no application site reactions.