PaxMedica, Inc. announced the completed execution of its three pivotal registration/validation batches of PAX-101, an IV formulation of suramin. This achievement is an important milestone to enabling a New Drug Application submission to the U.S. Food and Drug Administration, which is currently planned for Fourth Quarter 2024, and for the potential commercial availability in the U.S. of the first and only form of suramin for the treatment of Stage 1 Human African Trypanosomiasis, caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease, if approved by the FDA. Reaching this milestone is critical to PaxMedica's journey towards potential FDA approval for PAX-101, currently the accepted standard of treatment outside the United States for the deadliest cause of HAT, according to the CDC.

A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV). PaxMedica plans to fund a sustainable global supply chain for PAX-101, and further advance research and clinical trials to address Autism Spectrum Disorder. This underscores the company?s commitment to tackling some of the most challenging neurological conditions.