SR Pharma has announced the start of a phase II, randomised, placebo-controlled, trial of SRP299 (a killed Mycobacterium vaccae suspension) for the treatment of moderate-to-severe atopic dermatitis (eczema) in children aged 5 to 16. SR Pharma and Genesis Research and Development Corporation are jointly developing SRP299 together with AVAC for the treatment of atopic dermatitis.
The trial, which aims to recruit 120 evaluable patients, will be conducted in ten research centres across the United Kingdom and Ireland. The trial will evaluate the effects of SRP299 on the extent and severity of atopic dermatitis, assess the duration of action of SRP299 and patients' quality of life. The trial will also monitor the safety and tolerability of SRP299. Each patient will be randomised to one of three treatment arms and will receive a single injection of either a standard dose SRP299, a low dose of SRP299 or placebo.
"This trial provides an excellent opportunity for SR Pharma to evaluate the efficacy and safety of SRP299 in children suffering from moderate-to-severe eczema", said Dr. David Kennard, Managing Director of SR Pharma. "SRP299 is already being evaluated in the treatment of mild-to-moderate asthma. This additional study represents an important milestone in the development of SRP299 as a novel treatment for the management of atopic dermatitis."
Results from a previous trial conducted by Dr. Peter Arkwright of Booth Hall Children's Hospital in Manchester reported that treatment with killed M. vaccae significantly improved the symptoms of children aged between 5 and 18 years and suffering from moderate-to-severe atopic dermatitis. Three months after treatment those children given a single dose of M. vaccae showed a mean 48% reduction in surface area affected by dermatitis (compared with 4% in placebo group). A median 68% reduction in dermatitis severity score (compared with 18% for placebo group) was also observed.
Atopic diseases comprise atopic dermatitis, asthma and allergic rhinitis. An atopic individual is likely to experience symptoms of one or more of these conditions from an early age and this may persist for lengthy periods during their lifetime.