Paradigm Biopharmaceuticals Ltd’s (ASX:PAR) successful Phase 2A Ross River Virus (RRV) clinical trial results have been peer-reviewed and published online in the journal, BMC Musculoskeletal Disorders.
'Pentosan Polysulfate Sodium [PPS] for Ross River Virus (RRV)-Induced Arthralgia: A Phase 2A, Randomised, Double-Blind, Placebo-Controlled Study' was published online on March 12, 2021.
The data produced in the pilot study provide clinical evidence that PPS may offer patients a treatment option for a disease that has little or no therapeutic options for chronic RRV infection.
Compelling clinical and scientific evidence
Paradigm chief science officer Dr Ravi Krishnan said: “We are very pleased that the data from this double-blind, placebo-controlled pilot study has provided compelling clinical and scientific evidence to suggest that PPS can be safely administered to subjects with RRV induced arthralgia and demonstrate improved clinical outcomes in pain and function.
“In addition, the data are supportive of the anti-inflammatory and chondroprotective (cartilage) actions of PPS which showed reduction in inflammatory biomarkers.
“The findings in RRV induced arthralgia complement the actions of PPS in other musculoskeletal indications in osteoarthritis and MPS which involve pain and dysfunction.”
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Significant spike in RRV cases
Principal investigator and infectious disease physician Dr Paul Griffin added: “Recently, we have observed a significant spike in cases of Ross River virus fever in NSW, Victoria and Queensland.
“Following the acute phase of RRV fever, many patients will experience in the coming weeks persistent debilitating joint pain and there are currently no satisfactory treatments available.
“As the principal investigator on Paradigm’s Phase 2A RRV clinical trial, I am very pleased that the data have been acknowledged by robust scientific peer-review and the work is now published.
“Most importantly, the data supports the use of PPS as a potentially effective treatment for the disease symptoms of RRV-induced arthralgia and may alter the course of the illness”.
The published study demonstrated that iPPS is a safe and effective treatment in participants with chronic and sustained symptoms (arthralgia) associated with RRV.
The publication describes the details of the Phase 2A study, its background, design, treatment interventions and the outcomes for the per-protocol population (18 subjects, 11 iPPS and seven Placebo) who completed the full course of treatment and final follow-up.
RRV Special Access Scheme
In the last 12-months, Paradigm has commenced preparations to make iPPS available via the TGA Special Access Scheme (SAS), to physicians treating patients with persistent pain and loss of joint function due to arthralgia associated with RRV.
Currently, physicians have limited therapeutic options when treating the persistent symptoms associated with RRV, as no treatment has shown to shorten the duration or alter the course of RRV.
Analgesics (paracetamol and aspirin) and NSAIDS are recommended, although, there is limited relief of symptoms by most patients.
Corticosteroids can improve outcomes but are generally not recommended due to risks outweighing any benefit.
The findings from the Phase 2 study have now been validated through the peer-review process.
This will inform infectious disease physicians regarding the potential use of PPS for RRV induced arthralgia where there are no other treatment options.
The TGA SAS for RRV will be a patient pay-for-use program and will be available in Q2 CY2021 at up to 10 clinics across Australia.
Clinic selection will be dependent on adherence to strict patient safety monitoring protocols during the treatment cycle.
Paradigm will update the market further on participating clinics and pricing once they have been finalised.
Ross River Virus
RRV is a mosquito-transmitted alphavirus that causes epidemic polyarthritis and arthralgias, which may lead to significant muscle and joint damage.
It is Australia’s most common arbovirus affecting 4,000-5,000 people per year.
RRV most commonly occurs in adults aged 25-44 years, with males and females equally affected. The incubation period is seven-nine days, with a range of 7-21 days.
In the acute phase, functional ability can be significantly impaired, with about 50% of patients requiring time off work.
Joint pain is present in 95% of patients, most commonly affecting fingers, toes, wrist, ankles, elbows and knees.
The disease is associated with significant morbidities during the first few months following diagnosis, with arthralgias have a prolonged effect more than three months after diagnosis in over two-thirds of RRV patients.