Modus Therapeutics Holding AB announced today the successful completion of patient enrollment in its SEVUSMART Phase I clinical trial, which is evaluating the safety and tolerability of sevuparin in pediatric patients with severe malaria. The study is being conducted in collaboration with Imperial College London and is funded by Wellcome.
The trial has enrolled 20 children between the ages of 3 months and 12 years who have been diagnosed with severe malaria at clinical sites in Kenya and Zambia. The primary objective is to assess the safety profile of escalating doses of sevuparin when administered alongside the current standard of care for severe malaria.
Sevuparin is Modus Therapeutics' proprietary drug candidate that has previously demonstrated promising effects against the malaria parasite. Earlier studies, including those in patients with uncomplicated malaria and ex vivo investigations (Leitgeb et al. 2017, Saiwaew et al. 2017), have shown the drug's potential efficacy against the parasite.
John Öhd, CEO of Modus Therapeutics, expressed his satisfaction with this milestone: "The successful completion of patient enrollment marks an important milestone for the SEVUSMART study and is a testament to the dedication of Professor Kathryn Maitland and her research team at Imperial College London and the KEMRI-Wellcome Trust Programme in Kilifi, Kenya, as well as the hardworking study teams in Kenya and Zambia. We are proud to be part of this important collaborative effort and look forward to the upcoming study results."
Mechanism of Action and Clinical Potential
Sevuparin works by targeting key mechanisms involved in severe malaria pathophysiology. By interfering with these processes, the drug has the potential to reduce disease severity and improve patient outcomes. The compound's unique mechanism of action makes it a promising candidate for adjunctive therapy in severe malaria cases, where current treatment options remain limited.
The drug's development represents a significant step forward in addressing an area of substantial unmet medical need. Severe malaria continues to be a major global health challenge, particularly affecting young children in endemic regions across sub-Saharan Africa and parts of Asia.
Study Design and Objectives
The SEVUSMART trial employs a dose-escalation design to carefully evaluate sevuparin's safety profile in the vulnerable pediatric population. By determining the optimal dose of sevuparin in combination with current standard antimalarial treatments, the study aims to establish the foundation for further clinical development.
The trial is being conducted at established research centers with extensive experience in malaria clinical research, including sites affiliated with the KEMRI-Wellcome Trust Programme in Kenya and partner institutions in Zambia.
Global Health Impact
Severe malaria remains one of the most significant infectious disease challenges worldwide, with children under five years of age bearing the greatest burden. Despite advances in prevention and treatment, the WHO estimates that malaria caused over 600,000 deaths in 2021, with the majority occurring in young children in Africa.
Current standard treatments for severe malaria, primarily injectable artesunate, have improved outcomes but mortality rates remain high. Adjunctive therapies like sevuparin could potentially address the complex pathophysiology of severe malaria that antimalarial drugs alone do not target.
The results from the SEVUSMART study will provide critical insights for future clinical research evaluating sevuparin as an adjunctive treatment for severe malaria. If successful in later-stage trials, sevuparin could become an important new tool in the management of this devastating disease, potentially saving thousands of young lives annually.
