PaxMedica, a clinical stage biopharmaceutical company, has announced positive top line results from the PAX-101 Phase 3 African Sleeping Sickness study. The study successfully achieved its primary endpoint and demonstrated statistically significant and clinically meaningful results. These findings are an important step towards filing an NDA for the use of PAX-101 in the treatment of African Sleeping Sickness.
The study, known as PAX-HAT-301, compared the health outcomes of patients treated with suramin, an intravenous drug therapy, to a control group who received no treatment prior to the availability of suramin in Africa. The results showed that suramin led to better health outcomes for patients. The adverse events observed during the study were consistent with what has been reported in existing medical literature.
PaxMedica has outlined its plans to submit an NDA for the use of PAX-101 in treating Stage 1 African Sleeping Sickness to the FDA in 2024. If approved, suramin will become the first drug indicated for this condition in the United States. This achievement could potentially qualify PaxMedica to