Astralis initiates US Phase I trial for novel psoriasis treatment
New Jersey-based biotechnology company Astralis, in which UK drug delivery company SkyePharma holds a minority equity stake, has initiated a Phase I clinical trial in the US for Psoraxine, a novel injectable treatment for moderate psoriasis.
New Jersey-based biotechnology company Astralis, in which UK drug delivery company SkyePharma holds a minority equity stake, has initiated a Phase I clinical trial in the US for Psoraxine, a novel injectable treatment for moderate psoriasis.
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.
Psoraxine is a protein-based therapy that is believed to stimulate cells from the patient's immune system to reverse the inflammatory process responsible for psoriasis symptoms. While developing an improved vaccine for leishmaniasis, Dr Jose O'Daly, chairman of the board and head of r&d for Astralis, noticed that vaccinated patients with psoriasis saw their symptoms resolve. The second generation version of Psoraxine to be used in the US trials is a purified protein fraction.
Michael Ashton, SkyePharma's ceo, said: 'We look forward to working with Astralis to validate the very promising results from the previous studies in Venezuela. Despite the recent introduction of some new approaches to psoriasis, there remains a substantial opportunity for a safe and effective new therapy.'