PaxMedica Sees Positive Data in Suramin Trial for African Sleeping Sickness

By Chris Wack

PaxMedica said Monday it saw positive top line data for its retrospective analysis of suramin treatment for stage 1 trypanosoma brucei rhodesiense human African trypanosomiasis, also known as African sleeping sickness.

The biopharmaceutical company said the conclusions of the study confirmed that the retrospective, externally controlled, interventional efficacy and safety study of suramin demonstrated better health outcomes when compared with a natural history control group of patients prior to the availability of suramin in Africa.

The adverse event profile of suramin observed in the study was consistent with what has been widely reported in published medical and clinical literature.

PaxMedica said it is expecting to file a new drug application with the U.S. Food and Drug Administration for the use of PAX-101 to treat stage 1 African sleeping sickness in 2024. If approved, suramin will be the first drug indicated for the treatment of TBR HAT in the U.S., and would potentially qualify PaxMedica to receive a priority review voucher under the Neglected Rare Tropical Disease Program in section 524 of the Food, Drug, and Cosmetics Act.

PaxMedica shares were up 27% to $1.02 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 24, 2023 08:34 ET (12:34 GMT)

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