SkyePharma PLC's partner Astralis Ltd has initiated a Phase I clinical trial in the USA for Psoraxine, a novel injectable treatment for moderate psoriasis, a common chronic skin condition. A first generation version of Psoraxine has already been studied extensively in Venezuela, where nearly 3,000 patients participated in open-label clinical studies, the vast majority showing a positive response with few side-effects.

Through a service agreement, SkyePharma is providing development, manufacturing, pre-clinical and clinical development services to Astralis for a second generation version of Psoraxine, up to the completion of Phase II clinical studies. In the event that Phase II studies are successfully completed, Astralis will offer SkyePharma the option to acquire the worldwide licensing and distribution rights to Psoraxine. SkyePharma has a minority equity stake in Astralis.

Michael Ashton, SkyePharma's Chief Executive, said "We are delighted that the US Food & Drug Administration has authorized the start of US clinical studies of Psoraxine. We look forward to working with our partner Astralis to validate the very promising results from the previous studies in Venezuela. Psoriasis remains a common and highly debilitating condition with well-recognized failings in standard treatments. Despite the recent introduction of some new approaches to psoriasis, there remains a substantial opportunity for a safe and effective new therapy."

The double-blind, placebo-controlled US study is being conducted by Dr. William Abramovits, Professor of Dermatology at Baylor University Medical Center, Dallas, Texas. The trial will evaluate the safety of a single dose of Psoraxine in patients with moderate psoriasis that has lasted for more than three months and covers between 3% and 15% of the body surface. Psoraxine is administered by intramuscular injection and the trial will encompass three dose ranges of 50, 150, and 300 micrograms in addition to a placebo control arm. The study will also provide some preliminary information on efficacy using measures of psoriasis severity and Quality of Life improvement.