Modus Therapeutics Holding AB (publ) announced the inclusion of the first patient and the start of SEVUSMART, an Imperial College London/Wellcome sponsored phase I clinical trial evaluating the Company's proprietary drug sevuparin in paediatric patients with severe malaria. The SEVUSMART phase I trial will evaluate the safety and tolerability of escalating doses of sevuparin in up to 20 paediatric patients aged 3 months to 12 years presenting with severe malaria at the Kilifi County Hospital, Kilifi, Kenya. The study is designed to identify the appropriate dose of sevuparin together with standard of care in severe malaria to be taken forward in future clinical studies.

Sevuparin has already shown promising effects on the malaria parasite in patients with uncomplicated malaria and in human samples (Leitgeb et al 2017, Saiwaew et al 2017). The trial is the result of a collaboration between Modus and a team led by Professor Kathryn Maitland from Imperial College London, UK. The project is funded by a collaborator grant in science from Wellcome (209265/Z/17/Z) to Professor Maitland's research group at KEMRI-Wellcome Trust Programme, Kilifi Kenya and to the international consortium "Severe Malaria Africa - a consortium for Research and Trials" (SMAART), the goal of which is to identify and research new treatments for severe malaria.

Modus is currently developing sevuparin in sepsis/septic shock, and other conditions with systemic inflammation, of which severe malaria constitutes an example. Severe malaria remains an unaddressed medical problem in the parts of the world with endemic malaria. The condition primarily affects young children infected with the parasites.

In severe malaria, the parasitic infection causes a systemic inflammation syndrome that shares similarities with sepsis and other severe conditions which uncontrolled may then progress into shock and multi-organ failure.