Modus Tx - Immunoglycan for Sepsis
Modus aims to save countless lives using an immunoglycan, Sevuparin, that thins the blood to prevent blood clots without the risk of unwanted bleeding.
Sweden
2011
Public
Phase II
Challenge
Sepsis, a life-threatening response to infection, affects over 50 million individuals annually, claiming approximately 11 million lives. It remains the single most significant cause of death globally, more so than the top four most common cancers combined. There are currently no treatments specifically approved for sepsis, despite the massive social and economic burden it poses.
Modus Therapeutics aimed to redefine sepsis treatment using an immuno glycan, Sevuparin, to prevent blood clots without the risk of unwanted bleeding. The company planned to transition from a Phase Ib challenge study to a Phase II A study involving 60-80 patients.
Results
AI was used to evaluate potential countries for the study, identifying countries with high capacity for sepsis patients. This led to a selection focused mainly on European countries, including the UK, France, Germany and two others. The decision on countries also informed the selection of clinical sites of which 5-7 high-capacity sites were analyzed.
95%
Increase in data usability
84%
decrease in feasibility analysis time
Process
Indication Feasibility: Understanding the scope and needs of the disease is paramount. Modus first conducted a Phase Ib challenge study to evaluate the feasibility of various aspects of the trial, including the complex conditions that come with treating sepsis. This step laid the groundwork for understanding how to design a clinical trial for a condition as complicated and widespread as sepsis.
Country-Specific Feasibility: Modus undertook a critical evaluation of countries based on factors like existing medical infrastructure, regulatory environments, and public awareness of sepsis. They focused on European countries with supportive medical authorities, specifically those with lenient regulatory frameworks. The goal was to identify countries where the trials would be both possible and impactful.
Landscape Analysis: Historical and competing studies were analyzed to determine the most efficient and effective approach for the clinical trial. Neuroute created a model for patient recruitment, considering demographics, healthcare systems, and logistical challenges. Projections allow teams to allocate resources more effectively.
Site Analysis and Selection: Based on historical data and currently competing studies, 5-7 high-capacity sites were selected across European countries, ensuring that each site had the potential to yield reliable and scalable data. Sites were given a score by historical randomization rate and availability of facilities for Sepsis.
Conclusion
The targeted approach to country and site selection enabled Modus to move forward with the clinical trial, optimized for both impact and efficiency. This sets the stage for potential groundbreaking advances in sepsis treatment. The case proves the critical role that meticulous planning and data-driven decision-making can play in the success of a clinical trial, particularly for conditions as complex and prevalent as sepsis.