Sevuparin Fails to Show Clinically Meaningful Improvements in Managing VOCs, Phase 2 Study Shows
Sevuparin, Modus Therapeutics' lead therapeutic candidate for managing painful vaso-occlusive crises (VOCs), failed to show clinically meaningful improvements in patients with sickle cell disease (SCD), Phase 2 clinical trial results show. Modus Therapeutics is part of Karolinska Development’s portfolio of pharmaceutical companies. Karolinska Development is a Sweden-based investment company focused on identifying and supporting breakthrough medical innovations developed by other companies. Sevuparin is an investigational drug with anti-adhesive and anti-inflammatory properties that has been developed to prevent the obstruction of blood vessels and restore normal blood flow, reducing the risks of VOCs, one of the most common and painful complications of SCD. The multicenter, randomized, double-blind, placebo-controlled, Phase 2 trial (NCT02515838) was designed to assess the safety and effectiveness of continuous intravenous infusion of sevuparin for the management of painful VOCs in SCD patients over the course of two to seven days, compared to a placebo. The trial's primary outcome was to assess the time of VOCs resolution after administering sevuparin. Secondary outcomes included treatment safety assessments, drug pharmacokinetic properties, mean change in pain intensity, duration of the most severe pain, and cumulative dose of opioids. (Pharmacokinetics is the study of how a drug is absorbed, distributed, metabolized, and eliminated from the body.) The study enrolled 144 SCD patients from multiple sites across Europe, the Middle East and the Caribbean. Unfortunately, according to statements from Karolinska Development, findings from the trial failed to show clinical benefits associated with the use of sevuparin. "It is disappointing that sevuparin did not demonstrate a meaningful clinical benefit in the Phase 2 study conducted by Modus Therapeutics, particularly as patients with sickle cell disease have no treatment options that can reduce the length of their vaso-occlusive crises or manage their pain, other than opioids. Modus will now consider options for further development of sevuparin in other indications where its multimodal action may have utility," Viktor Drvota, CEO of Karolinska Development, said in a press release. Karolinska said in it announcement that it will return with updated information as soon as Modus Therapeutics makes a final decision regarding the future direction of its development project involving sevuparin.