SCD is a genetic blood disorder characterised by severely painful VOCs that lead to organ damage. Credit: National Center for Advancing Translational Sciences (NCATS), National Institutes of Health.

Swedish biotech firm Modus Therapeutics has dosed the first cohort of healthy volunteers in its Phase I clinical trial being conducted to evaluate sevuparin for the potential treatment of vaso-occlusive crisis (VOC) in order to mitigate pain in people with sickle cell disease.

Sevuparin is a polysaccharide drug with a multimodal mechanism of action that is believed to exhibit anti-adhesive, anti-aggregate and anti-inflammatory effects.

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VOCs are considered to be responsible for various sickle cell disease-related complications such as organ failure and stroke. Previous research found that decreasing the number of VOCs could improve patient outcomes and increase survival rates.

The double-blind, placebo-controlled, single ascending dose Phase I trial is designed to assess the safety, tolerability and pharmacokinetics of subcutaneous sevuparin injections.

“The Phase I study with subcutaneously-administered (SQ) sevuparin will pave the way for a therapy that could be used on demand.”

Around 24 healthy subjects will be enrolled in three ascending single dose cohorts at a site in the US.

This trial will complement a Phase II study investigating the use of intravenous infusion of sevuparin in restoring blood flow and preventing microvascular obstructions in patients with VOCs caused due to SCD.

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The Phase II trial completed enrolment last month and is expected to report data mid this year.

Modus Therapeutics chief medical officer John Öhd said: “While our recent Phase I study focused on treating patients with VOC by intravenous (IV) sevuparin infusion, the Phase I study with subcutaneously-administered (SQ) sevuparin will pave the way for a therapy that could be used ‘on demand’ as a patient feels an oncoming painful VOC.

“We see an incredible opportunity for subcutaneous sevuparin as the only therapy in development with the potential to be used at home for the treatment of vaso-occlusion, expanding treatment options for SCD patients to the early hours of a VOC.”

The company noted that subcutaneous formulation of the therapeutic has the potential for self-administered at home by patients.