Paradigm Biopharmaceuticals Ltd (ASX:PAR) has successfully dosed its first participant in its Phase 2 Alphavirus clinical trial of the drug pentosan polysulfate sodium (PPS) for the treatment of Ross River virus.
The commencement of the trial signifies strong momentum and depth in Paradigm’s clinical trial pipeline, making it the company’s fourth active clinical trial since listing on the ASX.
Trial subjects will be evaluated for safety, tolerability and effects on disease symptoms, with results anticipated in the June quarter of 2018.
Paul Rennie, CEO, commented: “New treatments for the condition are desperately needed, especially in Victoria, where the rates of the disease have increased significantly, representing a large unmet medical need.
“Whilst current therapeutics can help to manage the joint pain associated with the virus, they have not been shown to treat the detrimental effects on joint cartilage that are associated with the disease.”
Phase 2 Alphavirus clinical trial
The first participant was treated at the Barwon Health site in Geelong and is the first participant to be enrolled in the trial which is being conducted across two sites in Victoria and Queensland.
The randomised, double-blinded placebo-controlled clinical trial will treat a total of 24 subjects across both the Victorian and Queensland sites.
Patients with Ross River induced arthralgia (painful joints) will be evaluated for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections.
Results are anticipated in mid-2018.
Paradigm and Griffith University received a non-dilutive grant of A$300,000 from the Queensland Government during the quarter to accelerate the development of PPS to treat Ross River virus.
Victorian weather causes spike in Ross River
The incidence of Ross River virus in Victoria has spiked so far this year, with high amounts of rainfall and warm weather resulting in an unusually high number of infections.
A total of 1,911 cases have been identified in the half year ending June 30 this year, an 86.2% increase on 2016’s total of 263 cases.
PPS could also treat a second virus
PPS was also tested in the preclinical model of the Chikungunya virus and proven to be successful in treating the disease.
The Chikungunya virus is more widespread compared to RRV and the Pan American Health Organisation and the World Health Organisation reported for the first six months of CY2017 over 1 mln cases of the virus in the Americas alone.
Paradigm continues its discussions with the U.S. Department of Defense regarding the development of PPS for a treatment for Chikungunya virus infections.