- Paradigm Biopharmaceuticals (PAR) receives Australian ethics approval for its trial on patients suffering knee osteoarthritis pain
- Paradigm has nominated eight sites across five states to conduct the Australian arm of the PARA_OA_002 study, with patient recruitment and screening scheduled to begin during Q4
- The phase three clinical trial will look to evaluate the treatment effects of pentosan polysulfate sodium against a placebo, analysing a change in each patient’s pain
- The company says it expects to receive a response from the US FDA for its investigational new drug application before the end of September, ahead of starting the American arm of the study
- Paradigm Biopharmaceuticals last traded at $2.05 on September 23
Paradigm Biopharmaceuticals (PAR) has received Australian ethics approval for its trial on patients suffering knee osteoarthritis pain.
Paradigm has nominated eight sites across five states to conduct the Australian arm of the PARA_OA_002 study, with patient recruitment and screening scheduled to begin during Q4.
The phase three clinical trial will look to evaluate the treatment effects of pentosan polysulfate sodium against a placebo. The primary endpoint of the study will be a change from baseline at Day 56 in WOMAC pain.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used set of standardised questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, analysing pain, stiffness and physical function.
Secondary outcomes of the study include changes from the baseline at multiple time points, out to day 168 in WOMAC pain and function and quality of life.
The company said it expects to receive a response from the US FDA for its investigational new drug application before the end of September, ahead of starting the US arm of the study.
Paradigm’s Chief Executive Officer Paul Rennie said commencing the phase three study is a significant milestone for the company.
“We expect that, in addition to the eight Australian sites, there will be clinical sites in UK and Europe and, subject to the FDA’s response, in the US,” said Mr Rennie.
“Our preparation to expand into these additional sites is well underway.”
Paradigm Biopharmaceuticals last traded at $2.05 on September 23.