- Paradigm Biopharmaceuticals (PAR) completes recruitment for its phase two clinical trial for treating knee osteoarthritis (OA)
- The phase two study aims to evaluate the treatment of pentosan polysulphate sodium (PPS) against a placebo in 60 subjects
- The data collected will mark the first OA clinical trial information reported by Paradigm since the release of a Phase 2B clinical trial in 2018
- PAR says it remains on track for the day 56 interim data to be released to the market in the third quarter of 2022
- Paradigm Biopharmaceuticals ended the financial year trading at 96.5 cents
Paradigm Biopharmaceuticals (PAR) has completed recruitment for its phase two clinical trial for treating knee osteoarthritis (OA).
The phase two study aims to evaluate the treatment of pentosan polysulphate sodium (PPS) against a placebo on synovial fluid biomarkers in participants with knee osteoarthritis pain.
Knee osteoarthritis is a chronic progressive disease of the whole joint, where patients experience persistent pain and progressively reduced joint function.
A total of 60 subjects have been recruited to receive a once-weekly treatment over a six-month period. The trial is being run across two sites in Victoria and New South Wales, and will gather data on the medium to long-term effects of PPS on knee OA.
The data collected will mark the first OA clinical trial information reported by Paradigm since the release of a Phase 2B clinical trial in 2018.
Paradigm said it expects to release data at key milestones, such as the day 56 biomarker and clinical endpoints, six-month MRI and clinical endpoints, and one-year follow-up clinical effect duration endpoint data.
PAR said it remains on track for the day 56 data interim to be released to the market in the third quarter of 2022.
Meanwhile, Paradigm is concurrently conduction a trial in dogs with naturally occurring OA to generate further data establishing the in vivo action of PPS.
In the proposed investigation, up to 21 dogs with osteoarthritis of the stifle joint will be treated with three milligrams per dog kilogram of PPS or placebo via subcutaneous weekly injection for six weeks.
The company will assess the clinical outcomes of pain and function through X-rays and MRI scans.
Paradigm plans to announce the canine data in the third quarter of 2022.
Paradigm Biopharmaceuticals ended the financial year trading at 96.5 cents.