Serentis begins trial with first-in-class SRD441 for eczema

Apr 9 2009

Serentis, a privately owned biopharmaceutical company, announced that it has commenced patient recruitment in a Phase II clinical trial for atopic dermatitis (AD), a type of eczema.

The Phase II, double-blind, vehicle-controlled study will determine the efficacy, safety and tolerability of SRD441 in patients with AD. The 28-day study in adults with mild or moderate AD is being conducted in twelve sites across Europe and will measure acute efficacy as defined by the Investigators' Global Assessment (IGA), a clinical endpoint commonly used in AD trials.

Dr Robert Tansley, Serentis' Chief Medical Officer, commented: “AD is a common condition with an increasing incidence. In a study of over 2,000 patients, a significant majority identified the need for an effective treatment that would give long-term control of their eczema and a much needed improvement to their quality of life 1 . SRD441 represents a new approach with a novel mechanism of action in the treatment and maintenance of AD.”

Last month Serentis announced the start of another Phase II trial for SRD174 for the treatment of pruritus (itch) associated with AD. Tim Sharpington, Serentis' Chief Executive Officer, said: “Both products are first-in-class compounds targeting innovative approaches to address significant unmet medical need in dermatology.”

Results from the Phase II study for SRD441 are expected later this year.

About Atopic Dermatitis

AD is commonly known as eczema and is a chronic, relapsing skin condition, characterised by intense itching, dry skin and redness. The disease follows a course of periodic flare ups and remissions.

The disease predominantly affects children, typically starting in infancy. In the developed world, AD is estimated to affect 15-30% of children and 2-10% of adults 2,3 . There has been a steady increase in the condition over the last few decades.

Patients suffering from AD not only have to contend with the symptoms of their condition but also the large impact on their quality of life. Patients, particularly children, may suffer from lower self-esteem or levels of confidence because of their eczema.

About SRD441

SRD441 is a small molecule, protease inhibitor with a novel mechanism of action for the topical treatment and maintenance of AD. It targets over-expressed proteases in the skin of patients with AD, as well as pro-inflammatory proteases produced by the bacterium staphylococcus aureus , which often colonises the skin of AD patients. This dual inhibition of proteases is designed to maintain the skin barrier in patients with AD and to reduce a major driver of eczema flares.

The product has the potential to treat acute symptoms of AD and to provide maintenance treatment for long-term disease management.

A Phase I, double-blind, vehicle-controlled trial of SRD441 in healthy volunteers completed in December 2008 concluded that SRD441 is well tolerated.