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     109  0 Kommentare PaxMedica Receives Emergency Request for IV Suramin from African Health Ministry for Use in Treating Fatal Sleeping Sickness - Seite 2

    It is important to note that, of the 349 patients who were included in our Real World retrospective evidence, HAT-301 clinical study of TBR HAT patients treated with suramin between 2000 and 2020, many of the cases were from Malawi. (PaxMedica - A Promising Path in Autism) “Having the highest incidence of TBr HAT in the world, the Malawi Ministry of Health enabled PaxMedica to conduct the first and only analysis of efficacy in the actual setting where historically the vast majority of these infections have been successfully treated”, said Weisman. “This pivotal Phase 3 study would not have been possible without their multi-year commitment to our work on PAX-101.”

    PaxMedica is in the process of responding to the Malawi Ministry of Health’s request and is in contact with regulatory authorities in both the U.S. and Malawi with an intention to help with today’s emergency, as well as to work with the FDA to determine the best path forward to submit the PAX-101 NDA for regulatory approval, as well as to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide PaxMedica resources to help ensure a steady supply of suramin to these endemic regions.”

    About PaxMedica

    PaxMedica, Inc. is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (APT) aimed at addressing a range of challenging neurologic disorders. Our comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as Autism Spectrum Disorder (ASD), as well as other critical areas within the neurology field. Additionally, we intend to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for Stage 1, Trypanosoma Brucei Rhodesiense. 

    We are dedicated to the continuous development and evaluation of our pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of our efforts, particularly focused on innovative ASD treatment solutions. Our ongoing research initiatives not only prioritize the needs of ASD patients, but also extend to exploring potential therapeutic applications for related conditions. To learn more about our transformative work, please visit www.paxmedica.com.

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    PaxMedica Receives Emergency Request for IV Suramin from African Health Ministry for Use in Treating Fatal Sleeping Sickness - Seite 2 Emergent shortages of the drug used to treat the most severe form of African sleeping sickness creates immediate need for direct access to the global drug market for affected nationsAs previously reported, PaxMedica recently executed final …