arGentis anticipates the confirmation process by the European Commission should be finalized in early 2009. Once confirmed, arGentis subsidiary, arGentis Autoimmune Europe, will gain access to incentives including 10 years marketing exclusivity throughout Europe for the therapeutic indication for which it was granted, facilitated access to the centralized procedure for the application for marketing approval, reduced fees associated with applying for marketing approval and protocol assistance, and access to EU research funding grants.
ARG201 is an immunotherapy that induces low dose oral immune tolerance in systemic sclerosis patients causing downregulation of the body’s autoimmune response. It has completed a Phase II clinical trial. The trial included patients with the diffuse form of systemic sclerosis.
According to the company, data from the trial demonstrated a statistically and clinically significant improvement in modified rodnan skin scores, a measure of the change in skin thickening and an FDA-mandated endpoint, at 15 months in late phase patients receiving the treatment versus the placebo group (p=0.006). ARG201 was also shown to be safe and well-tolerated.
Tom Davis, CEO of arGentis Pharmaceuticals, said: This is another very important milestone in our efforts to prepare ARG201 for late phase clinical development. Along with the US orphan drug designation received in 2008, arGentis identified that achieving the orphan drug designation in the EU would position ARG201 for quicker global market entry. With the incentives afforded by both designations, we look forward to working with the two regulatory agencies to finalize the protocols for late phase trials.