PaxMedica submits clinical trial request in Autism Spectrum Disorder

PaxMedica 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. 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.