Dilaforette, a portfolio company of Karolinska Development (STO: KDEV), a Nordic investor in life sciences, has been granted orphan drug designation by the US Food and Drug Administration for its sevuparin.
It has been granted the designation for sevuparin in sickle-cell disease, and the company is currently in the final stages of preparing for a Phase II study in this indication. Dilaforette aims to start recruitment of patients in the first half of 2015.
Sevuparin is a proprietary polysaccharide drug which has the potential to restore blood flow and prevent further microvascular obstructions. It could offer treatment of the underlying cause of vaso-occlusive crisis in sickle-cell disease patients, with earlier pain relief, shorter hospital stays, reduced need of opioids and improved quality of life.
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