·       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 nations

·       As previously reported, PaxMedica recently executed final registration and validation batches of PAX-101 (an IV form of suramin) in preparation for a future NDA submission as an orphan designated drug

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TARRYTOWN, New York, April 16, 2024 (GLOBE NEWSWIRE) - via IBN - PaxMedica, Inc. (NASDAQ: PXMD) a biopharmaceutical company focused on advancing treatments for neurological disorders, today announced it has received an urgent request from the Ministry of Health (MOH) of Malawi, asking for emergency access to IV suramin to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used routinely to save lives in that region of Africa.

PaxMedica, which just last week announced that it has completed execution of its three pivotal registration/validation batches of PAX-101(an IV form of suramin), has brought this emergency request to the attention of the U.S. Food and Drug Administration (FDA) to determine potential impact, if any, on the ongoing development program and NDA submission plans for PAX-101.  PaxMedica has previously announced the completion of its recent Type B meeting with FDA in preparation for submitting an NDA for the use of PAX-101 in the treatment of the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, caused by the bite of a tsetse fly.

“Receiving this request from The Ministry of Health of Malawi serves to emphasize, not only the challenging situation faced by the countries in the most vulnerable zone for the fatal disease, TBr HAT, it speaks to the continued need for suramin as the standard of care in treating Stage 1of the infection, using what’s known as the Malawi dosing protocol, which they have used in an effort to save lives in that region for nearly 100 years”, said Howard Weisman, Chairman and CEO of PaxMedica. “FDA has agreed that having more than one global manufacturer of drugs like suramin could provide public health benefit by creating multiple supply chains and would help ensure a steady supply of the drug product.”

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.   “Thispivotal 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 thePAX-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 .”

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 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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Forward-Looking Statements

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