Modus Therapeutics AB announces the initial results from its Phase II, randomized, double-blind, placebo-controlled study with sevuparin for the management of acute vaso-occlusive crisis (VOC) in patients with sickle cell disease. Data from the study failed to show a meaningful benefit in the total study population, however, the data suggests that sevuparin, at the administered doses, is safe and well tolerated in this patient population. Modus is considering its options for further development of sevuparin.
The global Phase 2 study included 144 patients at clinical sites across Europe, the Middle East and the Caribbean. The study compared intravenously (IV) administered sevuparin with placebo in patients admitted to the hospital with an acute VOC associated with SCD. The study also assessed several pain-related secondary end points. The Phase 2 study was conducted by Modus Therapeutics with its co-development partner, Ergomed, a full-service contract clinical development organization with an internationally-recognised specialist expertise in orphan drug development.
“We are disappointed that sevuparin did not demonstrate a meaningful clinical benefit in this large Phase 2 study, particularly as SCD patients have no treatment options to manage their pain other than opioids. We would like to recognize and thank all the patients, investigators and site staff across the world who participated in this study” said Ellen K Donnelly, PhD, CEO of Modus Therapeutics. “We recognize the importance of these data in helping to better understand sickle cell disease biology and we are committed to ensuring that the full data is disclosed at a future scientific conference.”
“We continue to believe that a drug with sevuparin’s multimodal action and encouraging safety profile may have utility in other indications and will be carefully considering the path forward for its further development” added Dr. Donnelly.
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.