The first cohort has been successfully dosed in the Phase 1, single ascending dose study to explore the pharmacokinetics and safety and tolerability of subcutaneous sevuparin injections in healthy volunteers (HV).
This study complements a large Phase 2 study which completed enrollment in January 2019 and will report data in mid-2019.
“This Phase 1 study launches an important pillar of our strategy to treat vaso-occlusion and thereby reduce pain by providing SCD patients with a novel, non-opioid, therapy that can be dosed at home,” commented John Öhd, CMO of Modus Therapeutics. “While our recent Phase 2 study focused on treating patients with vaso-occlusive crisis (VOC) by intravenous (IV) sevuparin infusion, the Phase 1 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.”
The VOCs, or “painful crises”, are a hallmark of SCD and are believed to contribute to the patient’s gradual accumulation of complications such as organ failure and stroke. Research suggests that reduction of the number of VOCs should improve patient outcomes and could increase the lifespan of these patients.