Key milestone is achieved in the development of PAX 101 and an update is provided on potential NDA submission for the treatment of Stage 1 Human African Trypanosomiasis
PaxMedica, Inc, a biopharmaceutical company focused on advancing treatments for neurological disorders, 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 (NDA) submission to the FDA, which is currently planned for Q4 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 (HAT), 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.
“This is a very significant milestone forPaxMedica as it endeavors to move PAX 101 towards an NDA submission,” said Howard Weisman, chairman and CEO of PaxMedica. “The long-term vision for PaxMedica is to further clinical investigation of PAX 101 as a treatment for individuals who struggle with Autism Spectrum Disorder. With this important manufacturing milestone completed, we have removed a major impediment to testing PAX 101 as a treatment for the core symptoms of Autism Spectrum Disorder. This also progresses us towards our goal of being able to be a consistent and reliable global source of this lifesaving drug for the treatment of HAT currently listed as one of the World’s Essential Medicines. It is our goal to ultimately conduct clinical trials for the use of PAX 101 in the treatment of the core symptoms of Autism Spectrum Disorder. There are currently no approved medications for the core symptoms Autism Spectrum Disorder.”
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