PaxMedica Submits Clinical Trial Request in Autism Spectrum Disorder

• ASD-101 protocol submitted to SAHPRA, South Africa’s regulatory agency
• PAX-101 internally developed supply chain entering final stages

TARRYTOWN, NY, June 14, 2023 (GLOBE NEWSWIRE) -- via – PaxMedica, Inc. (Nasdaq: PXMD), a clinical stage biopharmaceutical company focusing on the development of novel anti-purinergic drug therapies (APT) for the treatment of Autism Spectrum Disorder (ASD) and other serious conditions with intractable neurologic symptoms, today announced that it has submitted a request to the South African Health Products Regulatory Authority (SAHPRA), seeking approval to conduct a double-blind, placebo-controlled study, PAX-ASD-101.  This trial will seek to enroll a total of 30 subjects with confirmed ASD, ages 4 to 18, at multiple sites in South Africa.  This is the first new clinical trial on the safety, tolerability, and efficacy of suramin since the Company announced the results of its prior Phase II trial in 2021. Enrollment is expected to begin in Q4 2023, following SAHPRA’s potential approval later this summer.

PaxMedica is also preparing additional submissions for planned PAX-101 trials with other regulatory authorities outside of South Africa in 2023.

“In 2021, PaxMedica reported that it had completed a Phase II clinical trial on the use of suramin in boys with ASD.  That trial achieved marked and sustained improvement in several efficacy assessment measures and demonstrated tolerability and safety across two different doses of PAX-101,” said Howard Weisman, CEO of PaxMedica. “The results of this new proposed trial will inform the submission of an IND for multicenter trials in the US with PAX-101.”

PaxMedica is in the final stages of scaled manufacturing of the PAX-101 API and drug product to ensure the availability of the drug for clinical trials, registration and validation for both HAT and ASD programs.

About PaxMedica

PaxMedica is a clinical stage biopharmaceutical company focusing on the development of anti-purinergic drug therapies (“APT”) for the treatment of disorders with intractable neurologic symptoms, ranging from neurodevelopmental disorders, including Autism Spectrum Disorder (“ASD”), to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”), a debilitating physical and cognitive disorder believed to be viral in origin and now with rising incidence globally due to the long term effects of SARS-CoV-2 (“COVID-19”). One of PaxMedica’s primary points of focus is the development and testing of its lead program, PAX-101, an intravenous formulation of suramin, in the treatment of ASD and the advancement of the clinical understanding of using that agent against other disorders such as ME/CFS and Long COVID-19 Syndrome, a clinical diagnosis in individuals who have been previously infected with COVID-19.

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Contacts:

Stephanie Prince

PCG Advisory



(646) 863-6341