Paradigm Biopharmaceuticals Ltd (ASX:PAR) has enrolled the first patient in the exploratory PARA_OA_008 knee Osteoarthritis (OA) Biomarker study.
This participant has been randomised and has begun study procedures, including joint aspiration to collect baseline biomarker synovial fluid Information, at Sportsmed Biologic in Box Hill, Victoria.
The treatment phase has commenced with the participant receiving the first dose of injectable Pentosan Polysulfate Sodium (iPPS) or Placebo and will continue at two injections a week subcutaneously for a six-week period.
This study will investigate changes in knee synovial fluid biomarkers associated with pain, inflammation and disease progression of knee OA.
“Generating data for TGA submission”
Paradigm CEO and chairman Paul Rennie said: “We are very pleased to have progressed to the treatment phase of the knee synovial fluid Biomarker study, by dosing of the first participant.
“This study has been designed to generate clinical data which will inform of the potential of Zilosul® as the first in class disease modifying OA drug (DMOAD).
“Additionally, the data generated will form part of Paradigm’s submission package to the TGA for the next step of the provisional approval application.”
Trial design
Paradigm previously reported ethics approval and trial design for the knee OA Biomarker study with the primary purpose of this Phase 2b study to measure the change in synovial fluid biomarkers associated with pain, inflammation and osteoarthritis disease progression following treatment with subcutaneous injections of PPS compared with subcutaneous injections of placebo in participants with knee OA.
Sixty participants with Kellgren-Lawrence grade 2, 3 or 4 and have OA pain will be enrolled and randomised 1:1 to receive either PPS (n=30) or placebo (n=30).
Participants will receive twice weekly subcutaneous injections for six weeks.
Next steps
Additional participants have commenced the screening process and may begin the treatment phase over the next few weeks, subject to meeting inclusion criteria.
The company intends to update investors on key study milestones as they are achieved with the primary endpoint data expected in the second half of 2021.