On June 1, 2023, PaxMedica, Inc. announced that the eligibility review and final enrollment for the Company's Real World Evidence study (HAT-301) has been completed. The HAT-301 study is the first and only retrospective clinical study of suramin in the treatment of Rhodesian African Sleeping Sickness, also known as Stage 1 Trypanosoma Brucei Rhodesiense Human African Trypanosomiasis (TBR HAT), a rare and universally fatal infectious disease. Suramin has been the standard of care for treating TBR HAT for many decades, solely based on empirical evidence derived during mass epidemics of TBR HAT.

The official database lock for HAT-301 will occur in June 2023, with top-line data for this study expected to be available in July 2023, and pave the way for filing an NDA for the use of PAX-101 in TBR HAT in 2024. If approved, suramin will be the first drug indicated for the treatment of TBR HAT in the United States, and would possibly qualify PaxMedica to receive a Priority Review Voucher (PRV) under section 524 of the Food, Drug, and Cosmetics Act (FD&C Act). A PRV, once granted, is an independently valued asset, granted to a sponsor company after NDA approval and, according to section b)2) of the act, can be sold by that sponsor to any biopharmaceutical company to obtain FDA priority review in a future filing of any NDA.

With this achievement, PaxMedica has completed a critical step in filing for potential U.S. market approval for this important, life-saving treatment. The opportunity to raise significant non-dilutive funding, as a result of potential successful participation in the Neglected Rare Tropical Disease Program through receipt of a PRV, may enable future large-scale trials of PAX-101 in Autism, and other important conditions, in the very near future.