The company announces that the FDA has accepted its sevuparin IND for the treatment of SCD.
“The FDA’s decision to accept the IND application for the development of sevuparin in sickle cell disease will allow us to start our clinical development program in the U.S. and constitutes an important milestone in our efforts to provide patients with effective and convenient therapies to treat their disease,” said Ellen K Donnelly, CEO of Modus Therapeutics.
Sevuparin is a polysaccharide drug with anti-adhesive, anti-aggregate and anti-inflammatory effects due to its multimodal mechanism of action. Sevuparin has the potential to restore blood flow and prevent further microvascular obstructions in children and adults with SCD, states the company.
Phase II study
At present, sevuparin is being evaluated in a Phase II study in SCD patients with ongoing painful crises (also called vaso-occlusive crises (VOC).
“The expansion of our clinical program into the U.S. is an important milestone for the company,” said John Öhd, CMO of Modus Therapeutics. “It specifically allows the start of studies in man evaluating the subcutaneous administration of sevuparin, which we believe to be key in broadening its clinical scope and utility in the treatment of sickle cell disease.”
Photo of John Öhd, CMO of Modus Therapeutics: Medivir