Creabilis' CT327 Phase 2b Data Published in Acta Dermato-Venereologica, Strengthens Scientific Advisory Board

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Mar 19, 2015, 04:30 ET

CANTERBURY, England, March 19, 2015 /PRNewswire/ --

Prestigious peer-review journal accepts paper demonstrating a reduction of pruritus (itch) in psoriasis patients treated with its novel TrkA kinase inhibitor CT327
Appointment of pre-eminent pruritus experts Professor Gil Yosipovitch as Chair and Professor Sonja Ständer to the Creabilis Scientific Advisory Board

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^[1] 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,^[2] 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.

Creabilis also announced today the strengthening of its Scientific Advisory Board (SAB) to prepare it for Phase 3 development of CT327. Professor Gil Yosipovitch, Chair of the Department of Dermatology at the Temple University School of Medicine, Director of the Temple Center for Itch and one of the world's pre-eminent experts in itch, has been appointed Chair of the SAB. In addition, Professor Sonja Ständer, Professor for Dermatology and Neurodermatology at the Department of Dermatology, and Head of the Interdisciplinary Competence Center Chronic Pruritus (KCP) of the University Hospital Münster, Germany, joins as a new SAB member.

Professor Yosipovitch commented: "I am excited to be leading Creabilis' Scientific Advisory Board at this important time in CT327's development. Chronic Pruritus has a significant impact on the quality of life of patients with psoriasis and there is a clear unmet medical need for a safe, effective topical anti-pruritic. Based on the robust data from the Phase 2b trial, now reported in the prestigious dermatology journal Acta Dermato-Venereologica, I believe that CT327 could have a significant impact in the treatment of pruritic conditions such as pruritus due to psoriasis and offers broad development opportunities in the future to address other pruritic indications."

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 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 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.

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 trials with CT327 are underway, with a clear route to the peripheral pruritus market via the initial indication of pruritus due to psoriasis. 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.

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1. David Roblin, Gil Yosipovitch^*, Brent Boyce, John Robinson, James Sandy, Valentina Mainero, Ro Wickramasinghe, Uma Anand⁶, and Praveen Anand^: Topical TrkA kinase inhibitor CT327 is an effective, novel therapy for the treatment of pruritus due to psoriasis: Results from in vitro and tissue experimental studies, and efficacy and safety of CT327 in a Phase 2b, randomised, double-blind, vehicle-controlled clinical trial in patients with psoriasis. Acta Derm Venereol. 2015 Jan 16. doi: 10.2340/00015555-2047. [Epub ahead of print]

2. David Roblin, Ro Wickramasinghe, and Gil Yosipovitch. Pruritus severity in patients with psoriasis is not correlated with psoriasis disease severity. J Am Acad Dermatol. [http://www.ncbi.nlm.nih.gov/pubmed/24438964 ] 2014 Feb;70(2):390-1

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

Further information:

Creabilis
Simon Russell
Chief Business Officer
Email: [email protected]

Consilium Strategic Communications
Amber Bielecka, Jessica Hodgson, Laura Thornton
Tel: +44-(0)-203-709-5701
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