Paradigm Biopharmaceuticals Ltd (ASX:PAR) is now ready to commence its Phase 2 Alphavirus clinical trial of the drug pentosan polysulfate sodium (PPS) for the treatment of Ross River virus.
Ethics approval and site initiation of the two sites at Mater Research in Brisbane, Queensland and Barwon Health in Geelong, Victoria, means the company can commence participant recruitment.
The trial will recruit 24 participants with Ross River virus (RRV) in Queensland and Victoria - the dosing of the first participant is expected in the coming weeks.
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: “We look forward to recruiting participants and to commence dosing over the coming weeks.
“We hope that PPS can prove effective through this Phase 2 trial, especially as there are no effective pharmaceutical treatments available to RRV sufferers, making this a true unmet medical need.”
Clinical trial details
The randomised, double-blinded placebo-controlled clinical trial will treat a total of 24 subjects across both trial sites.
People with RRV-induced arthralgia (painful joints) will be evaluated for safety, tolerability and effects on disease symptoms of PPS subcutaneous injections, with results anticipated in mid-2018.
Other sites in Queensland are also being evaluated for this clinical trial.
Other trial updates
The Phase 2a Open Label Bone Marrow Edema Lesion trial is due to read-out at the end of the current September quarter.
Furthermore, the Phase 1 and Phase 2 Hay Fever clinical trials are complete and Paradigm is waiting on analysis of data.
Analysis
The Ross River clinical trial is Paradigm’s fourth clinical trial that has commenced in less than two years demonstrating its operational discipline to execute on its clinical development plans.
The Ross River virus affects hundreds of thousands of people in South Asia each year and there is currently no effective treatment for either disease.
Furthermore, the pre-clinical trial work has been peer-reviewed and published in the Journal of Virology.
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 million cases of the virus in the Americas alone.