PaxMedica has submitted a request to the South African Health Products Regulatory Authority (SAHPRA) for approval to initiate a clinical trial of PAX-101, an intravenous formulation of suramin, to treat autism spectrum disorder (ASD).
The placebo-controlled, double-blind PAX-ASD-101 study will assess the tolerability, safety, and efficacy of suramin in ASD patients.
It intends to enrol a total of 30 subjects aged four to 18 years with confirmed ASD, at multiple South African sites.
PaxMedica CEO Howard Weisman said: “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.
“The results of this new proposed trial will inform the submission of an IND for multicentre trials in the US with PAX-101.”
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Patient enrolment for the trial is anticipated to begin in the fourth quarter of this year, following the regulatory agency’s potential approval.
PaxMedica is also seeking approvals with other regulatory authorities outside of South Africa to initiate PAX-101 trials this year.
PAX-101 is also being studied as part of its lead programme in treating long Covid-19 and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS).
The company is manufacturing PAX-101 API, which is currently in the final stages.
This month, PaxMedica has also signed a research collaboration agreement with PoloMar Health to investigate the use of the anti-purinergic compound emodin in treating ASD.
PoloMar Health agreed to sponsor the study while the BRAIN Foundation will provide funding.