PaxMedica reports results from PAX-101 Phase 3 African sleeping sickness Study

PaxMedica announced positive top line data for the Company’s PAX-HAT-301 Retrospective Analysis of Suramin Treatment for Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis, S1 TBR HAT. The conclusions of the study confirmed that the retrospective, non-randomized, externally controlled, interventional efficacy and safety study of suramin for the treatment of Stage 1 TBR HAT demonstrated better health outcomes when compared with a natural history control group of patients evaluated and treated from 1900-1910, prior to the availability of suramin in Africa. PaxMedica is expecting to file an NDA 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 United States, 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.