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Creabilis to Present CT327 Phase 2b Data at American Academy of Dermatology (AAD) Annual Meeting

March 21, 2014

CANTERBURY, England, March 21, 2014 /PRNewswire/ –

        - Phase 2b data demonstrates a 60% reduction in pruritus in psoriatic
          patients treated with CT327
        - Data analysis also published in the Journal of the American Academy of
          Dermatology
        - Phase 2b CT327 topline data in patients with Atopic Dermatitis and Pruritus
          due in mid-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.”

Notes to Editors:

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: http://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

SOURCE Creabilis


Source: PR Newswire



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