PaxMedica, a biopharmaceutical company, announced on Monday that it has obtained positive top-line data from its retrospective analysis of suramin treatment for stage 1 African sleeping sickness, also known as trypanosoma brucei rhodesiense human African trypanosomiasis.
According to the conclusions drawn from the study, the retrospective analysis of suramin as an intervention showed better health outcomes compared to a natural history control group of patients who did not have access to suramin in Africa. This externally controlled study confirmed the efficacy and safety of suramin.
It is worth noting that the adverse event profile of suramin observed in the study aligns with what has been widely reported in medical and clinical literature.
PaxMedica has plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) seeking approval for the use of PAX-101 in the treatment of stage 1 African sleeping sickness by 2024. If granted approval, suramin will become the first drug indicated for the treatment of trypanosoma brucei rhodesiense human African trypanosomiasis in the U.S. Furthermore, this achievement could potentially make PaxMedica eligible to receive a priority review voucher under the Neglected Rare Tropical Disease Program specified in section 524 of the Food, Drug, and Cosmetics Act.
Following this news, PaxMedica shares experienced a 27% increase in value during premarket trading, reaching $1.02.
