Creabilis Announces Treatment of First Patients in its Phase 2b Trial of CT327 in Pruritus in Atopic Dermatitis Patients

CANTERBURY, England, September 18, 2013 /PRNewswire/ --

Creabilis, a late clinical stage European dermatology company with a focus on pruritus (itch), today announces 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, randomised, 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 analysed. 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.

About Creabilis

Creabilis is a late clinical stage European biotechnology company with a primary focus in chronic pruritus (itch), a debilitating symptom of many dermatological diseases with a negative impact on quality of life. Chronic pruritus is an area of significant unmet need, with no medicine currently approved for its treatment.

Creabilis has delivered positive Phase 2b results for CT327 in the treatment of pruritus in psoriasis patients. CT327 is a novel, first-in-class, topically delivered TrkA kinase inhibitor. CT327 was developed using Creabilis' proprietary Low Systemic Exposure (LSE) 'topical-by-design' technology. LSE creates molecules optimized for topical applications. Planning for Phase 3 with CT327 is underway, with a clear route to market and an estimated >$800m in peak annual sales.

Creabilis' pipeline also includes CT340, a potent narrow spectrum kinase inhibitor in development for the topical treatment of neuropathic pain, an area of significant unmet medical need. Like CT327, CT340 was developed using the Company's Low Systemic Exposure (LSE) technology. CT340 is IND-ready and first-in-human studies will commence in 2013.

Creabilis is backed by highly respected life science investors Sofinnova Partners, Neomed and AbbVie Biotech Ventures Inc., and is led by an experienced Management team, with over 100 years of combined R&D experience in pharma and biotech, and over 20 drug approvals. Creabilis has corporate and R&D functions in the UK and Italy.

About Pruritus and CT327

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 one of the most important symptoms of psoriasis. There is no medicine currently approved for the topical treatment chronic pruritus and there is a significant unmet need for targeting treatment of chronic pruritus that combines efficacy with a good safety profile. CT327 inhibits TrkA kinase, the high affinity receptor for Nerve Growth Factor (NGF), and is believed to reduce the sensitisation of sensory neurons, a process which plays a pivotal role in the pathogenesis of pruritus.

About the Technology Strategy Board

The Technology Strategy Board is the UK's innovation agency.  Its goal is to accelerate economic growth by stimulating and supporting business-led innovation.  Sponsored by the Department for Business, Innovation and Skills (BIS), the Technology Strategy Board brings together business, research and the public sector, supporting and accelerating the development of innovative products and services to meet market needs, tackle major societal challenges and help build the future economy. For more information please visit http://www.innovateuk.org.

For further information please contact:

Creabilis
Eliot Forster
Email: eforster@creabilis-sa.com
Address: Creabilis, 6 Denne Hill Business Centre, Canterbury CT4 6HD, UK
                   
Citigate Dewe Rogerson
Chris Gardner
E-mail: chris.gardner@citigatedr.co.uk
Tel: +44(0)20-7282-2995