Modus Therapeutics AB, a company developing innovative treatments in disease areas with high unmet medical need with a focus on sickle cell disease (SCD), 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, PhD, CEO of Modus Therapeutics.
Sevuparin is an innovative, proprietary 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. 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”, added John Öhd MD, PhD, 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.”
Sickle cell disease is an inherited blood disorder that affects between 90,000-100,000 individuals in the U.S. 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 the life expectancy of patients with SCD and lifetime medical care costs can exceed $1M per patient with an estimated $1B spent annually in the U.S.