Modus Therapeutics announces FDA Acceptance of Sevuparin IND for treatment of sickle cell disease
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.
FOR THE EDITORS
About Modus Therapeutics AB
Modus Therapeutics is a Swedish biotech company developing sevuparin for diseases with high unmet medical need with a focus on sickle cell disease (SCD). Sevuparin is currently being tested in a Phase II clinical study for SCD – a painful, inherited blood disorder affecting millions of people around the globe. Sevuparin has the potential to improve the SCD patients’ blood flow reducing their pain and the amount of time they will need to spend in hospital.
The investors in Modus are KDev Investments AB, (part of Karolinska Development AB (Nasdaq Stockholm: KDEV) and Rosetta Capital), HealthCap, The Foundation for Baltic and European Studies (Östersjöstiftelsen) and Praktikerinvest AB. For more information, please visit www.modustx.com
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 a number of diseases including SCD. In SCD, the anti-adhesive effects of sevuparin could thereby offer treatment of the underlying cause of vaso-occlusive crisis (VOC) in SCD patients, with earlier pain relief, fewer and shorter hospitalizations, reduced need of opioids and improved quality of life. Modus is currently enrolling patients in a Phase II study with the aim to complete enrollment in the study in late 2018.
About sickle cell disease
Sickle cell disease (SCD) is a painful, inherited blood disorder affecting millions of people around the globe and the most common inherited blood disorder in the U.S. affecting between 90,000-100,000 subjects, with medical care costs amounting to more than $1 billion. In Europe it is estimated that there are 35,000-40,000 SCD patients, with an even higher number in the Middle East and North Africa regions, with over 850,000 SCD patients. SCD patients’ blood cells form a sickled shape, which makes blood flow to vital organs difficult during acute intermittent episodes called vaso-occlusive crises (VOC), leading to severe pain and even premature death.
There is currently no pharmaceutical product available that targets the vaso-occlusive activity during a VOC in SCD patients. At present, the standard of care relies on strong intravenous pain medications and SCD patients often must be hospitalized to be treated.
For further information, please contact:
Ellen K Donnelly, CEO, Modus Therapeutics:
Tel: +46 70 246 7554
David Dible/ Pip Batty, Citigate Dewe Rogerson
Tel: +44 20 7638 9571