Paradigm Biopharmaceuticals Ltd (ASX:PAR) is ahead of schedule with two phase II clinical trials.
Once the studies are complete in 2018, commercially valuable data will be available.
Patients are being treated with the drug pentosane polysulfate sodium (PPS) and the trial is randomised, double-blind and placebo-controlled.
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Paul Rennie, chief executive, said: “The trials are aimed at diseases for which there are very few safe and effective drugs.”
READ: Paradigm Biopharmaceuticals meets primary endpoint in clinical trial
The first study is evaluating the effects of PPS on pain in participants with knee osteoarthritis (OA) and concurrent subchondral bone marrow lesions.
It is almost 25% complete and well ahead of schedule.
PPS has potential to be a break-through osteoarthritis treatment
The company says injectable PPS has potential to be a break-through in the treatment of OA, which is the most common form of joint disease and a leading cause of pain and disability among the elderly.
“Current therapies do not have adequate pain-relieving effects, provide no protection for the degenerating joint structures and can also have significant adverse side effects,” Paradigm said.
The second study involves evaluating patients with Ross River virus (RRV) induced painful joints for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections.
There are 24 people taking part in trials in Victoria and Queensland.
The company says recruitment is more than 60% complete and the study is well ahead of schedule with results on track for mid-2018.
An influx of participants is expected in coming months as mosquito numbers rise.
Ross River virus is on the rise
The incidence of Ross River virus is on the rise in Australia and Papua New Guinea and recent research has shown that it has the potential to become a global epidemic, similar to the Zika virus.
Results from Paradigm’s study are expected to provide important safety data and will be further evaluated to design subsequent larger trials.
The company hopes that the trials will demonstrate the potential of PPS as an effective treatment for patients with persistent symptoms following Ross River virus infection, where a treatment is desperately needed.
In 2017 Paradigm has completed one phase II clinical trial and started two additional phase II clinical trials in arthritis.