Serentis Starts Phase II Clinical Trial In Pruritus Of Skin Disease

Main Category: Eczema / Psoriasis
Also Included In: Dermatology;  Clinical Trials / Drug Trials
Article Date: 05 Mar 2009 - 3:00 PDT

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Serentis, a privately owned biopharmaceutical company, announced today that it has started a phase II clinical trial in pruritus associated with atopic dermatitis (AD), a type of eczema. Pruritus, more commonly known as itch, is a major symptom of AD. The lack of effective treatments of pruritus has been identified as a major unmet medical need for patients with AD.1

The phase II, double blind, vehicle-controlled cross-over study is designed to determine the anti-pruritic efficacy, safety and local dermal toleration of SRD174 cream in patients with AD. The study is being conducted in 12 sites in the US.

Tim Sharpington, Serentis' Chief Executive Officer said "SRD174 is an innovative product with the potential to address a significant unmet need in the treatment of dermatological conditions. The initiation of this phase II study is an important milestone in the development of our clinical pipeline."

Results from the trial are expected later in the autumn of 2009.

About Pruritus

Pruritus, or itch, is a symptom of many skin diseases including AD and psoriasis. Pruritus is an essential feature for the diagnosis of AD.2,3 The often unbearable itch experienced by AD sufferers has led to it being referred to as the "itch that rashes". Pruritus has a significant impact on the quality of life of AD patients and in particular night time itch which deprives the patient of restful sleep.

In addition to the impact on quality of life, pruritus exacerbates the development of eczema flares associated with AD through what is referred to as the "itch-scratch cycle". Itching leads to scratching which damages the skin resulting in bleeding, risk of infection, lichenification (thickening of the skin) and inflammation causing further itching and so the vicious cycle continues. An important part of treating AD is breaking this itch-scratch cycle.

Pruritus associated with AD is identified as a key unmet medical need.

About SRD174

SRD174 is a topical product designed to produce rapid and long-lasting relief of pruritus. It is designed to have a fast onset of action that reduces itch after application and in so doing breaks the itch-scratch cycle. Its prolonged action of pruritic relief also offers the potential to relieve night time itch.

With limited products targeting the pruritus symptom of AD, SRD174 provides an exciting commercial opportunity addressing a high unmet medical need.

About Serentis

Serentis is a privately owned biopharmaceutical company founded in 2006 with the objective of developing a pipeline of innovative, proprietary products to address unmet medical needs.

The company's strategy is to establish a clinical-stage development pipeline and to move projects rapidly through proof-of-principle trials. The pipeline is sourced from in-house, low-risk research programmes and through licensing or acquisition of projects from external sources. The pipeline includes SRD441, a topical therapy with a new mode of action for the treatment of AD and SRD174.

For further information, visit http://www.serentis-pharma.com

References:

[1] Datamonitor, Stakeholder Opinions: Atopic Dermatitis, DMHC2279, 03/2007
[2] Koblenzer CS; Itching and the atopic skin; J Allergy Clin Immunol 1999; 104: 109-13
[3] Hanifin JM, Rajka G; Diagnostic features of atopic dermatitis; Acta Derm Venereol Suppl (Stockh) 1980; 92: 44-7

http://www.serentis-pharma.com