Paradigm Biopharmaceuticals (ASX:PAR), a clinical-stage biopharmaceutical company focused on repurposing existing molecules for new indications with unmet clinical needs, says the first subjects have been randomised and dosed in the US in the PARA_OA_002 pivotal clinical trial.
The trial is evaluating injectable pentosan polysulfate sodium (PPS/Zilosul) for the treatment of pain associated with knee osteoarthritis (kOA).
The first subject randomisation was confirmed at Northwestern University, Chicago, by lead investigator Dr Thomas Schnitzer.
The pivotal phase 3 study is currently screening and enrolling subjects in eight sites across Australia and in 21 of the 56 selected sites in the US.
The company said site activations in the US will continue and UK and EU sites are also being initiated throughout the calendar year 2022.
Chief medical officer Dr Donna Skerrett said, “To have our first subjects randomised in the US is an important milestone in the OA clinical program. The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the US and we are seeing a large number of subjects entering the screening phase throughout the US. We look forward to continuing the strong momentum in the phase 3 program and reporting important recruitment milestones to our shareholders.”