Press release

Modus Therapeutics Announces Completion of Patient Enrollment in the SEVUSMART Phase I Study for Severe Malaria

11.03.2025, 13.45

Stockholm, Sweden – March 11, 2025: Modus Therapeutics Holding AB (“Modus”) announces that the Phase I clinical trial SEVUSMART, evaluating the safety and tolerability of sevuparin in children with severe malaria, is now fully enrolled. The trial is being conducted in collaboration with Imperial College London and is funded by Wellcome.

The SEVUSMART study aims to assess the safety of escalating doses of sevuparin in up to 20 children aged 3 months to 12 years diagnosed with severe malaria at study sites in Kenya and Zambia. By determining the optimal dose of sevuparin in combination with the current standard of care, the study seeks to pave the way for further clinical development.

Sevuparin, Modus’ proprietary drug candidate, has previously demonstrated promising effects against the malaria parasite in both uncomplicated malaria patients and in ex vivo studies (Leitgeb et al. 2017, Saiwaew et al. 2017). By targeting key mechanisms of severe malaria pathophysiology, sevuparin has the potential to reduce disease severity and improve patient outcomes.

“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,” says John Öhd, CEO, Modus Therapeutics.

Severe malaria remains a major global health challenge, particularly for young children in malaria-endemic regions. The results from SEVUSMART will provide critical insights to the future clinical research evaluating sevuparin as an adjunctive treatment for this devastating disease.

About Modus Therapeutics and sevuparin
Modus is a Swedish biotechnology company that is developing its proprietary polysaccharide sevuparin as a potential treatment for several major healthcare needs including sepsis, endotoxemia, severe malaria and other disorders with severe systemic inflammation as well as states of anemia, related to chronic inflammation such as kidney disease. There is a great need for new treatments that can effectively treat these conditions. Modus’ ambition is to create a paradigm shift in the care of these diseases, where sevuparin could provide therapeutic benefits. Modus Therapeutics is listed on the Nasdaq First North Growth market (“MODTX”). More information is available at www.modustx.com.

Sevuparin is a clinical stage, innovative proprietary polysaccharide drug with a multimodal mechanism of action, including immunomodulating, anti-adhesive and anti-aggregate effects. Sevuparin is a heparinoid with markedly attenuated anti-coagulation features that allows severalfold higher doses to be given, compared to regular heparinoids, without the associated risk for bleeding side-effects. Two routes of administration of sevuparin are currently being tested – an IV formulation for in-patient administration and a subcutaneous formulation that allows ambulatory and home care administration.