SEVUPARIN CLEARS FDA TO TREAT SICKLE CELL DISEASE.

 
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FDA has decided to accept Modus Therapeutics' IND application of sevuparin for the treatment of SCD. Sevuparin is an innovative, proprietary modified polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. It has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD.

At present, sevuparin is being evaluated as an intravenous infusion in a Phase II study in SCD patients with ongoing painful crises (also called vaso occlusive crises, VOC). In order to broaden the clinical scope and utility of sevuparin in the treatment of SCD, the expanded clinical program into the U.S. will be performed using a subcutaneous administration route.

Sickle cell disease is an inherited blood disorder that affects between 90,000-100,000 individuals in the US. It is characterized by severely painful VOCs that lead to organ damage due to a lack of oxygen delivery to the organs. Progressive organ damage limits...

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