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Creabilis SA To Present CT327 Phase 2b Data At American Academy of Dermatology Annual Meeting


3/21/2014 9:55:41 AM

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Canterbury, UK – 21 March 2014 – Creabilis Ltd, the dermatology company with the most advanced targeted topical treatment in development for chronic pruritus (itch), announces that data from its Phase 2b trial of lead compound, CT327, will be presented in The Latest in Dermatology Research Symposia at the 72nd Annual Meeting of the AAD in Denver, Colorado, USA. Professor Gil Yosipovitch, Chair of the Department of Dermatology at the Temple University School of Medicine and Director of the Temple Center for Itch, will present the data on Saturday 22 March at 16.15pm CST. CT327 is a novel topical targeted treatment for chronic pruritus in diseases of dermatology, such as psoriasis and atopic dermatitis, targeting the sensory neurones implicated in the disease through the inhibition of TrkA kinase. Chronic pruritus is an area of significant unmet need with no approved therapies. Existing anti-inflammatory therapies that have also been tried in the treatment of pruritus are often ineffective and poorly tolerated.

The presentation (Abstract #1470), “A novel topical targeted anti-pruritic treatment in Phase 2b development for chronic pruritus” will focus on the debilitating nature of chronic pruritus and importance of a targeted anti-pruritic approach for its treatment. Professor Yosipovitch will also present the recent Phase 2b data using CT327 in the treatment of pruritus in 160 psoriatic patients. In this clinical trial, 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 patient 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 patients reported at least moderate pruritus (VAS > 40mm). CT327 was safe and well tolerated, with no application site reactions. The abstract can be accessed at http://www.aad.org/File%20Library/Unassigned/AM14-Latest-in-Derm-Abstract-Book-FINAL-Version-2.pdf

Publication in the Journal of the American Academy of Dermatology

Creabilis also announces that it has published new results demonstrating that pruritus severity in psoriasis patients is not correlated with psoriasis disease severity in a letter to the Journal of the American Academy of Dermatology (JAAD). An analysis of data drawn from Creabilis’ Phase 2b study of CT327 in psoriasis patients showed no correlation between baseline pruritus severity and psoriasis disease severity.

The letter can be found online at: http://www.jaad.org/article/S0190-9622(13)01012-8/fulltext

Dr Eliot Forster, Chief Executive Officer of Creabilis, commented: “Chronic pruritus is a major clinical problem with significant market potential, where no topical medicines are currently approved. With the powerful efficacy and differentiated safety profile seen in this clinical trial, CT327 has the potential to be the first targeted topical anti-pruritic to come to market for this common condition.

“Presenting these data at such a prestigious conference and in a leading dermatology journal demonstrates the clinical significance of these data to the dermatology community. . We very much look forward to receiving the Phase 2b data in patients with pruritus in Atopic Dermatitis later this year.”

Professor Gil Yosipovitch, Creabilis Scientific Advisory Board Member, said: “Chronic Pruritus has a significant impact on the quality of life of patients with Psoriasis. These data give me hope that my patients will soon have a potent topical treatment option using this targeted anti-pruritic.”

About Pruritus

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 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 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 sensitisation of sensory neurons, a process that plays a pivotal role in the pathogenesis of pruritus.

About Creabilis

Creabilis is a dermatology company with the most advanced targeted topical treatment in development for chronic pruritus (itch). Creabilis has delivered positive Phase 2b results for CT327 in the treatment of pruritus in psoriasis patients. CT327 was developed using Creabilis' proprietary Low Systemic Exposure (LSE) 'topical-by-design' technology that creates molecules optimized for topical applications. Planning for Phase 3 with CT327 is underway, with a clear route to market. Creabilis' pipeline also includes CT340, an IND-ready and potent narrow spectrum kinase inhibitor in development for the topical treatment of chronic pain.

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. Creabilis' Corporate Headquarters and Development functions are based in the UK, with Research activities in Italy.

More information can be found at: www.creabilis-sa.com

Further information:

Creabilis
Eliot Forster
Chief Executive Officer
Email: info@creabilis-sa.com
Consilium Strategic Communications
Amber Bielecka, Jessica Hodgson, Melissa Jumbo
Tel: +44 (0) 203 709 5700
Email: creabilis@consilium-comms.com

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