PaxMedica receives South African regulatory approval for PAX-101 clinical trial in patients with Long COVID-19 Syndrome
10 January 2022 -

PaxMedica Inc., a US-based biopharmaceutical company, announced on Friday that it has received approval from the South African Health Products Regulatory Agency (SAHPRA) for its clinical trial application to study the impacts of PAX-101 (suramin intravenous (IV) infusions) in patients with Long COVID-19 Syndrome, also known as post-acute sequelae of SARS-CoV-2 infection.

The study is named PAX-LCS-101 and it will be a Phase 1B, prospective, randomised, placebo-controlled, double-blind, multiple-dose study. It is likely to start enrolling subjects in the first quarter of 2022 after receiving South African National Ethics Committee approval. This clinical trial is planned to study the safety and tolerability, efficacy, and PK of two doses of suramin (5mg/kg and 10mg/kg) in adults, 18 years and older, with LCS.

The product is also in phase two investigations for Autism Spectrum Disorder (ASD). The firm is also producing PAX-102, a proprietary intranasal formulation of suramin, for ASD and other neurologic disorders.