PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, has received an urgent request from the Ministry of Health (“MOH”) of Malawi requesting emergency access to IV suramin. According to the announcement, Malawi officials requested the suramin in efforts to avert a potential humanitarian crisis brought on by dwindling supplies of drugs used in that region of Africa; the drug is used specifically to treat the most severe form of African sleeping sickness. Last week, PaxMedica completed execution of its three pivotal registration/validation batches of PAX-101 (an IV form of suramin) in preparation for a future NDA submission to the U.S. Food and Drug Administration (“FDA”) as an orphan designated drug. With that in mind, PaxMedia has brought this emergency request to the FDA’s attention to determine potential impact, if any, on the company’s development program and NDA submission plans for PAX-101. “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 PaxMedica chair and CEO Howard Weisman in the press release. “[The] 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. . . . 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.”
To view the full press release, visit https://ibn.fm/Qxe6r
About PaxMedica Inc.
PaxMedica 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. The company’s 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, the company intends 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. PaxMedica is dedicated to the continuous development and evaluation of its pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of the company’s efforts, particularly focused on innovative ASD treatment solutions. The company’s ongoing research initiatives not only prioritize the needs of ASD patients but also extend to exploring potential therapeutic applications for related conditions. For more information about the company, visit www.PaxMedica.com.
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