PaxMedica reports first patient treated with PAX-101 for deadly African sleeping sickness infection Page 1

Company Provides Update on Regulatory Progress Toward U.S. NDA Filing

TARRYTOWN, NY / ACCESSWIRE / August 27, 2024 / PaxMedica, Inc. (OTC PINK:PXMD), a clinical-stage biopharmaceutical company focused on advancing treatments for neurological disorders, is pleased to announce a significant milestone in its global health efforts. The Malawi Ministry of Health has informed the company that a patient suffering from the potentially fatal parasitic infection known as Human Africa Trypanosomiasis Brucei Rhodesiense (HAT), commonly known as African Sleeping Sickness, was recently treated with PAX-101, an intravenous form of Suramin, and is recovering at home. The Rhodesiense strain of Human African Trypanosomiasis is nearly 100% fatal if not treated promptly, and Suramin is considered the standard of care in Malawi and many East African countries to prevent death from this parasite when used in the early or first stages of infection.

In April, the company announced that the Malawi Ministry of Health had issued an emergency request to PaxMedica for immediate access to recently completed validation and registration batches of PAX-101 (IV Suramin). This emergency request initiated several important steps to quickly respond to a critical global shortage of Suramin, which is routinely used to combat HAT in Malawi. PaxMedica notified the U.S. FDA Office of Global Policy and Strategy that the company had supplied a limited quantity of its formulation of IV Suramin, PAX-101, to the Malawi Ministry of Health for immediate use.

Howard Weisman, CEO of PaxMedica, commented, “This first use of PAX-101 to treat a critically ill patient with Stage 1 HAT infection is a significant milestone for the company following years of investment in the formulation and commercial scale-up of Suramin, the active pharmaceutical ingredient in PAX-101, with the company’s supply chain partners. We were approached by the Government of Malawi following persistent shortages of IV Suramin in the region over the past year, and we could not ignore their pleas for assistance. By responding to this extraordinary request, we are demonstrating our commitment to providing this vital medicine to some of the world’s most vulnerable people.”