Modus Therapeutics Completes Enrollment of its Randomized, Placebo-Controlled Phase II Clinical Trial Evaluating Sevuparin for the Management of Acute Vaso-Occlusive Crisis (VOC) in Patients with Sickle Cell Disease
STOCKHOLM, SWEDEN – 07 January 2019: Modus Therapeutics AB, a company developing innovative treatments in high unmet medical need disease areas with a focus on sickle cell disease (SCD), announces that it has completed patient enrollment in its Multi-Centre, Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Sevuparin Infusion for the Management of Acute Vaso-Occlusive Crisis (VOC) in patients with sickle cell disease.
This large, expanded, global Phase II study recruited over 140 patients at clinical sites across Europe and the Middle East. The study compared intravenously administered sevuparin with placebo in patients admitted to the hospital with an acute VOC associated with sickle cell disease. The primary endpoint of the study is the demonstration of a reduced time to resolution of patient’s VOC. The study was conducted in conjunction with Modus Therapeutics’ co-development partner Ergomed.
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. This study is targeting an area of high unmet medical need as there are currently no approved therapies for VOCs.
“Sickle cell disease has a complex pathophysiology that has made it difficult for therapies to demonstrate clinical efficacy in patients. We are hopeful that sevuparin, a derivative of heparin, will bring relief to sickle cell patients in pain due to its multi-modal mechanism of action and potential effects both as an anti-adhesive and anti-inflammatory therapeutic option. We look forward to working with patients, thought leaders and regulatory authorities as we readout the results of our Phase II study and plan the path to market for sevuparin,” said Ellen K Donnelly, PhD, CEO of Modus Therapeutics.
“We are happy to announce that our Phase II study with sevuparin has completed enrollment. We would like to thank all the patients, investigators and site staff across the world who participated in this important study. Painful crisis is a debilitating effect of SCD and we are committed to providing patients with an effective option to resolve these vaso-occlusive events in order to reduce their pain. We look forward to presenting our results later this year,” commented John Öhd MD, PhD, CMO of Modus Therapeutics.
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 $1million per patient with an estimated $1 billion 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.
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, Citigate Dewe Rogerson
Tel: +44 20 7638 9571