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news.arGentis Pharmaceuticals, a biopharmaceutical company, has announced that the European Medicines Agency has accepted the company's product candidate ARG201 for the treatment of diffuse systemic sclerosis, also known as systemic scleroderma for designation as an orphan medicinal product in the EU.
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According to the company, ARG201 is an immunotherapy that induces low dose oral immune tolerance in systemic scleroderma patients causing downregulation of the body’s autoimmune response. It has completed a Phase II clinical trial.
Tom Davis, CEO of arGentis, 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. We look forward to working with the two regulatory agencies to finalize the protocols for late phase trials.”