Modus Therapeutics Holding AB announced that recruitment has been completed into the company's clinical Phase 1b LPS provocation study evaluating the potential of its lead asset, sevuparin, for the treatment of sepsis and septic shock. The randomized, placebo-controlled Phase 1b study evaluates the effects of sevuparin on the symptoms of healthy volunteer participants who have been injected with the bacterial toxin lipopolysaccharide. Provocation with LPS is a well-established model used to characterize the early stages of septic inflammation by provoking a range of measurable symptoms. The study is also assessing the safety profile of sevuparin when used in combination with the standard prophylactic, blood-thinning heparin.

The Phase 1b study is being conducted in collaboration with the Center for Human Drug Research in Leiden, The Netherlands. CHDR is an independent Contract Research Organization specializing in advanced early clinical drug research and has strong expertise in advanced inflammation models. Data from the Phase 1b study will be used to inform the protocol of the planned Phase 2 study with sevuparin in patients with sepsis.

This study is expected to start in 2023. Sevuparin is a new polysaccharide drug that has the potential to break the molecular chain of events leading to vascular damage and plasma leakage in patients with sepsis or septic shock and other systemic inflammation conditions. Sevuparin does so by directly binding and neutralizing agents released from damaged white blood cells that are known to threaten the vascular integrity.