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PaxMedica Inc. (NASDAQ: PXMD) Seeking to Qualify for Neglected Tropical Disease Priority Review Voucher Program in Wake of Malawi Major Sleeping Sickness Crisis

  • PaxMedica has received an urgent plea from the Ministry of Health of Malawi for emergency access to IV suramin to prevent a potential humanitarian crisis due to dwindling supplies of essential drugs used to save lives in the region
  • PaxMedica has previously concluded a Type B meeting with the FDA in preparation for the NDA submission, focusing on the use of PAX-101 in treating the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, transmitted by tsetse flies
  • PaxMedica also aims to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide resources to ensure a steady supply of suramin to endemic regions

PaxMedica (NASDAQ: PXMD), a biopharmaceutical firm dedicated to advancing treatments for neurological disorders, recently announced that it has received an urgent plea from the Ministry of Health (“MOH”) of Malawi. The MOH is requesting emergency access to IV suramin to prevent a potential humanitarian crisis due to dwindling supplies of essential drugs used to save lives in the region (https://nnw.fm/bsNAM).

Following the recent completion of its three pivotal registration/validation batches of PAX-101 (an IV form of suramin), PaxMedica has promptly brought this urgent request to the attention of the U.S. Food and Drug Administration (“FDA”). The company aims to assess any potential impact on its ongoing development program and plans for submitting a New Drug Application (“NDA”) for PAX-101. PaxMedica has previously concluded a Type B meeting with the FDA in preparation for the NDA submission, focusing on the use of PAX-101 in treating the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, commonly called “sleeping sickness”, transmitted by tsetse flies.

Howard Weisman, Chairman and CEO of PaxMedica, emphasized the significance of the MOH’s request, highlighting the critical situation faced by countries vulnerable to the fatal disease TBr HAT. He underscored the continued necessity of suramin as the standard treatment for Stage 1 of the infection, particularly citing the Malawi dosing protocol used for nearly a century to save lives in the region.

Weisman also noted the potential public health benefit of having multiple global manufacturers of drugs like suramin, as it could create diverse supply chains and ensure a steady drug supply. PaxMedica’s Real World retrospective evidence, including the HAT-301 clinical study of TBR HAT patients treated with suramin between 2000 and 2020, involved a significant number of cases from Malawi. This underscores the importance of Malawi’s contribution to PaxMedica’s research efforts on PAX-101.

PaxMedica is actively engaging with regulatory authorities in the U.S. and Malawi to address the emergency request from the Malawi Ministry of Health. Additionally, the company is collaborating with the FDA to determine the optimal path for submitting the PAX-101 NDA for regulatory approval. PaxMedica also aims to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide resources to ensure a steady supply of suramin to endemic regions.

Wiseman also said [that 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.”

The most recent Bell2Bell Podcast sheds light on PaxMedica’s commitment to addressing the critical storage of medications required to combat the life-threatening sleeping sickness crisis in Malawi. The podcast features PaxMedica’s CEO and Malawi Health Official, Dr. Marshal Lemerani, discussing the urgency of the request made for suramin with host Stuart Smith. The full podcast can be found at https://nnw.fm/AxXAe.

For more information, visit the company’s website at www.PaxMedica.com.

NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://nnw.fm/PXMD

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