Phase 1b study evaluates the effects of sevuparin on the symptoms of volunteer participants.
Modus Therapeutics – a company developing treatments for patients with major unmet medical needs – has announced that recruitment has been completed into the company’s clinical phase 1b LPS provocation study evaluating sevuparin. The therapy concerns the treatment of sepsis and septic shock.
The randomised, 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 (LPS). Provocation with LPS is a well-established model used to characterise the early stages of septic inflammation by provoking a range of measurable symptoms.
The study will also assess the safety profile of sevuparin when used in combination with the standard prophylactic, blood-thinning heparin.
Research is being conducted in collaboration with the Center for Human Drug Research (CHDR) in the Netherlands. CHDR is an independent Contract Research Organization (CRO) specialising 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 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 neutralising agents released from damaged white blood cells that are known to threaten vascular integrity.
John Öhd, chief executive officer of Modus Therapeutics, commented: “We are very pleased to have met this milestone in our phase 1b clinical trial, which represents a significant step forward in our development programme intended to establish sevuparin as a ground-breaking new sepsis treatment.”
“It also highlights that our organisation, in conjunction with its partners, has been successful in delivering this objective in line with our updated plan and against the very challenging circumstances due to the lingering effects of the COVID-19 pandemic,” he added.
