Creabilis has announced that it has treated the first patients in its Phase 2b study of its lead product, CT327, in patients with atopic dermatitis (AD).
The Phase 2b trial is a multi-centre, randomized, double-blind, placebo-controlled study in adult and adolescent patients (older than 12 years) with mild to moderate atopic dermatitis and at least moderate pruritus.
The primary endpoints will assess pruritus using a visual analogue scale (VAS), and control of disease determined by Investigator Global Assessment (IGA).
Quality of life measures will also be analyzed. Two hundred and ten patients are expected to be enrolled and results are anticipated in Q2 of 2014.
CT327 (a TrkA kinase inhibitor) is a novel topical treatment for chronic pruritus in diseases of dermatology such as atopic dermatitis and psoriasis. CT327 acts to inhibit neurogenic inflammation and targets sensory neurones implicated in the pathology of chronic pruritus. There are currently no approved therapies for the treatment of chronic pruritus in dermatology.
Creabilis has already demonstrated a statistically significant and clinically meaningful reduction of pruritus and an improvement in psoriasis symptoms when compared to placebo vehicle in psoriasis patients treated with CT327 in a previous Phase 2b trial.
Dr Eliot Forster, CEO of Creabilis, said: “Atopic dermatitis is a debilitating and poorly treated dermatological disorder often described as ‘itch with a rash’. We have a strong scientific rationale for the potential of CT327 as a novel treatment for chronic pruritus and have already demonstrated positive results in the clinic. We look forward to completing this study, building on our previous Phase 2b data, and bringing CT327 one step closer to all patients suffering from this common disease for which there are no approved treatments.”
Dr David Roblin, CMO of Creabilis said: “AD and associated pruritus have a significant impact on patients’ and carers’ quality of life. Although some older treatments exist, there is a significant need for new therapies that are safe for long term use. A new therapeutic agent like CT327 that specifically addresses pruritus, the cardinal symptom of the disease, would make a real difference to patients.”
Technology Strategy Board Biomedical Catalyst Funding
Creabilis was one of the inaugural recipients of a Biomedical Catalyst Award from the UK’s innovation agency, the Technology Strategy Board, which has been used to partly fund the Phase 2b study in AD together with funding from existing investors. Creabilis is grateful to the Technology Strategy Board for its support.