Paradigm Biopharmaceuticals Ltd (ASX:PAR), a clinical-stage biopharmaceutical company focused on repurposing existing, approved drugs for new unmet medical needs, has received Australian ethics approval for a pivotal Phase 3 clinical trial, PARA_OA_002, to evaluate the treatment effects of pentosan polysulfate sodium (PSS) against placebo on participants with knee osteoarthritis (OA) pain.
This study will utilise the WOMAC™ (Western Ontario and McMaster Universities Osteoarthritis Index) standardised questionnaire to assess the drug’s effect when compared with placebo.
The primary endpoint will be change from baseline at day 56 in WOMAC ™ pain, with secondary outcomes to be judged from baselines at multiple points up to day 168, evaluating scores from WOMAC™ Pain and Function, Patient Global Impression of Change (PGIC) and Quality of Life (QoL) subscales.
Eight Australian sites
“We are pleased to report that preparations to commence our Phase 3 clinical trial are progressing whilst we await the US FDA’s response, expected at the end of September,” chief executive officer Paul Rennie said.
Paradigm has identified eight sites to conduct the Australian arm of the PARA_OA_002 study across Victoria, WA, Queensland, SA and NSW.
Patient screening and recruitment will commence during the fourth quarter of this year, with a response from the US FDA expected at the end of September for the US arm of the study.
"A significant milestone"
“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," Rennie said. "Our preparation to expand into these additional sites is well underway.
"Commencing the Phase 3 clinical study is a significant milestone for the company.”
Preclinical trials offer promising data
Preclinical studies published by PAR demonstrated that PPS treatment in an alphavirus chikungunga (CHIKV) mouse model can improve strength, swelling and inflammation. Improved pain and function were also demonstrated in preclinical trials, this time in a Ross River virus (RRV) study.
What is WOMAC™?
WOMAC™ is a widely used proprietary set of standardised questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip. The questionnaire consists of 24 questions divided into three subscales
- Pain (5): during walking, using stairs, in bed, sitting or lying and standing upright.
- Stiffness (2): after walking and later in the day.
- Physical Function (17): using stairs, rising from sitting, standing, bending, walking, getting in/out of a car, shopping, putting on/off socks, rising from bed, lying in bed, getting in/out of bath, sitting, getting on/off toilet, heavy domestic duties, light domestic duties.