Paradigm Biopharmaceuticals (ASX: PAR) has reported reduced disease symptoms during a phase 2a trial using its injectable pentosan polysulfate sodium (iPPS) drug on Ross River virus sufferers.
Of the 18 subjects that completed the trial and were suffering with Ross River virus induced arthralgia (join pain or stiffness), 11 were given iPPS, with the remainder treated with a placebo.
At the three-month follow up 72.7% of sufferers treated with iPPS showed “near remission” of symptoms, compared to 14.3% in the placebo group.
“We are very pleased to see that this small pilot Ross River virus study has yielded very promising safety data and key efficacy outcomes in the reduction of disease symptoms in this debilitating chronic phase of the disease,” Paradigm chief executive officer Paul Rennie said.
The primary endpoint of the trial was to demonstrate the safety of iPPS in Ross River virus patients.
According to the company, this was achieved with no “clinical significant differences” seen between the iPPS group and the subjects treated with a placebo.
The positive data paves the way for Paradigm to continue discussions with the US Department of Defense and pharmaceutical companies with tropical disease programs.
As well as Ross River, Paradigm is also evaluating the effect of iPPS in Chikungunya virus sufferers, which is closely related to Ross River and causes more than 3 million infections worldwide.
“The human data on effects of iPPS in Ross River virus induced arthralgia together with our preclinical work on Chikungunya virus will progress our commercial discussions with the US Department of Defense,” Mr Rennie noted.
Ross River virus
Ross River virus is transmitted by mosquitos and is Australia’s most common arbovirus, with about 5,000 cases reported.
The virus has around a nine-day incubation period and during the acute phase, functional ability is impaired with about half of all sufferers requiring time off work.
More than 95% of patients report joint pain with fingers, toes, writs, ankles, knees and elbows most commonly affected.
According to Paradigm, during the first few months of diagnosis, the disease is associated with “significant morbidity”, with arthralgia present more than three months after diagnosis in more than two thirds of patients.
There are reports of tiredness, joint pain and depression persisting for years following diagnosis.
To-date, there is no commercially available treatment for Ross River virus other than paracetamol or aspirin and corticosteroids. However, these have limited relief for sufferers.
In early morning trade, shares in Paradigm lifted 2.76% to reach $1.49.