Full Press Release Details
PaxMedica Receives Emergency Request for IV
Suramin from African Health Ministry for Use in Treating Fatal Sleeping Sickness
| 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 |
TARRYTOWN, NY / ACCESSWIRE / April 16, 2024 / 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 1 of 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. "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 ."
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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SOURCE: PaxMedica, Inc.