The South African Health Products Regulatory Agency (SAHPRA) has approved the application of PaxMedica to commence a Phase IB clinical trial of its therapy, PAX-101 (suramin intravenous (IV) infusions), in individuals with long Covid-19 syndrome (LCS).
PAX-101 is a clinically progressed therapy of the company.
Named PAX-LCS-101, the prospective, double-blind, randomised, multiple-dose, placebo-controlled trial is anticipated to begin subject enrolment in the first quarter of this year following approval from the South African National Ethics Committee.
It will assess the tolerability, safety, efficacy and pharmacokinetics (PK) of 5mg/kg and 10mg/kg doses of suramin in adult LCS patients aged 18 years and above.
The study also anticipates to enrol individuals with persistent LCS signs and debilitating physical and neuropsychiatric symptoms that continue for more than 12 weeks following a previous Covid-19 infection.
A serious, multi-system illness, LCS causes significant functioning impairment in several people following acute Covid-19 infection.
In addition, LCS diagnosis is difficult as there exist no specific tests for establishing the diagnosis. Symptoms vary between patients but frequently comprise fatigue, pain, headaches, brain fog, shortness of breath and decreased functioning, among others.
PaxMedica noted that LCS closely resembles another post-acute infection disorder called myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS). It intends to evaluate PAX-101 to treat LCS and ME/CFS.
PAX-101 is also currrently being analysed in trials to treat core and linked symptoms of autism spectrum disorder (ASD) in children.
Furthermore, PaxMedica is developing an intranasal formulation of suramin, PAX-102, for ASD as well as various other neurologic ailments.
Last September, RedHill Biopharma announced plans to start the Phase II/III trial of its drug RHB-107 (upamostat) for treating symptomatic Covid-19 patients in a non-hospital setting in South Africa.