Modus Therapeutics AB has published positive top-line data from its phase 1b lipopolysaccharide (LPS) provocation study, a key step in evaluating the potential of its lead asset, sevuparin, as a treatment for sepsis and other conditions with systemic inflammation.
In the study, healthy volunteers received LPS to induce a transient systemic inflammation reaction together with one of three dose levels of sevuparin, or placebo for six hours. They were then followed up at 24 hours post treatment. Provocation with LPS is a well-established model used to characterize the early stages of septic inflammation by provoking a range of measurable symptoms.
All three dose levels of sevuparin were found to be safe and well tolerated throughout the study period, confirming a favorable safety profile of the candidate drug under induced inflammatory conditions.
Sevuparin treatment induced statistically significant and dose-dependent increases in the levels of certain white blood cell populations as well as a dose-dependent inhibition of the increase in respiratory rate induced by LPS. These findings are indicative of clinically relevant and immunomodulatory effects exerted by sevuparin in a state of systemic inflammation.
The Swedish company said the study strengthens the potential for sevuparin as a treatment for systemic inflammation including sepsis and septic shock. This is an area of high unmet medical need as current treatment options fail to address the high disease burden of these critically ill patients.
Sevuparin also demonstrated a favorable safety and tolerability profile when combined with the blood thinning heparin (enoxaparin), an important standard of care in severely ill patient populations that need thrombosis prophylaxis.
Modus Therapeutics’ phase 2a study
The positive top-line data from this trial will be used to design Modus Therapeutics’ phase 2a study of sevuparin in patients with sepsis. This will include the dose of sevuparin to be assessed, the dosing schedule and the patient population for the planned patient study.
John Öhd, chief executive officer of Modus Therapeutics, said: “We are delighted by the encouraging results from our LPS-challenge study, a very important milestone in our mission to develop sevuparin as a fundamental change in the treatment for sepsis and other conditions with systemic inflammation. The results enhance our understanding of the immunomodulatory action of sevuparin and reinforce its potential in this area of extremely high unmet need.
“These data will also allow us to develop an optimized trial protocol for our planned phase 2a trial in sepsis patients. We would like to thank all our collaborators, who were critical to the success of this initial clinical study, for their continued support, and we look forward to providing more updates in the future.”
The phase 1b study was conducted in collaboration with The Centre for Human Drug Research in Leiden, The Netherlands, an independent Contract Research Organisation (CRO), which specializes in advanced early clinical drug research based on its leading expertise in inflammation models.