PaxMedica provides update on potential PAX-101 NDA submission

PaxMedica announced the completed execution of its three registration/validation batches of PAX-101, an IV formulation of suramin. The company said this achievement is an important milestone to enabling a new drug application, or NDA, submission to the FDA, which is currently planned for Q4 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, or HAT, caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease, if approved by the FDA. The company said 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, or 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.