The PAX-HAT-301 study compared data from medical records of Stage 1 TBR HAT patients treated with suramin between 2000 – 2020 at three medical sites in Uganda and Malawi to data from a patient cohort from the 1900-1910 TBR HAT epidemic in Uganda. 

The study findings affirm that suramin, administered in the treatment of Stage 1 TBR HAT, resulted in improved health outcomes compared to a natural history control group of patients assessed and treated between 1900-1910 before suramin became available in Africa. 

Among the suramin-treated patients, 94% survived and completed the treatment, while in the natural history cohort, only 14% were recorded as cured, improved, or discharged. 

The primary efficacy analysis showed that the health outcomes in the suramin-treated cohort were statistically significantly better than those in the natural history cohort.

The suramin's adverse event profile aligned with previously reported clinical literature.

PaxMedica plans to submit a New Drug Application (NDA) to the FDA in 2024 for using PAX-101 to treat Stage 1 African Sleeping Sickness. 

If approved, suramin would become the first drug in the U.S. for treating TBR HAT, potentially enabling PaxMedica to receive a Priority Review Voucher under the Neglected Rare Tropical Disease Program.

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