New treatment for viral arthritis reveals impressive results in Phase 2 human clinical trial
Griffith University's Institute for Glycomics and Melbourne-based company Paradigm Biopharmaceuticals Limited (ASX: PAR) have reported impressive results from their Phase 2A clinical trials of a new drug candidate to treat viral arthritis (joint pain/stiffness) caused by mosquito-borne alphavirus infections, including the debilitating Ross River virus (RRV) and chikungunya virus (CHIKV).
Griffith University and Paradigm Biopharmaceuticals entered into an exclusive commercialisation agreement in 2016 under which Paradigm would fund and undertake the necessary clinical trials en route to developing the technology to a marketed drug.
"We are extremely pleased that Paradigm's Phase 2A clinical trials have passed both safety and efficacy measures amongst participants with chronic RRV-induced arthralgia who were treated with the injectable pentosan polysulfate sodium (iPPS) drug candidate," said Dr. Lara Herrero, research leader at the Institute for Glycomics and lead inventor of the technology.
"At their three-month follow-up, 72.7% of those participants treated with iPPS showed near remission of symptoms in contrast to those participants who were administered with a placebo (14.3%)."
Mr Paul Rennie, Paradigm's Chief Executive Officer said: "We are delighted to see that this pilot RRV study has yielded promising safety data and key efficacy outcomes in the reduction of disease symptoms in this debilitating chronic phase of the disease."
"The human data on the effects of iPPS in RRV-induced arthralgia together with our preclinical work on CHIKV will progress our commercial discussions with the US Department of Defense," he added.
RRV is Australia's most common arbovirus, which causes epidemic polyarthritis and arthralgias, with about half of patients also experiencing fever and a rash.
"I am delighted that our researchers continue to make such important translational discoveries. There is no current treatment available to shorten the duration or alter the course of RRV-induced arthritis," said Professor Mark von Itzstein AO, Director of the Institute for Glycomics.
"I am looking forward to the next human clinical trial steps with this drug candidate as patients who contract the disease rely on pain relief drugs like aspirin or paracetamol and anti-inflammatories to relieve the symptoms of the disease."
Professor Andrea Bishop, Deputy Vice Chancellor (Research) at Griffith University commented on the potential of the findings: "CHIKV, another alphavirus which is closely related to RRV, causes more than three million infections worldwide each year. This new therapy offers us great hope in the global fight against these debilitating mosquito-borne alphaviruses."