Clinical stage biopharmaceutical company Paradigm Biopharmaceuticals Ltd (ASX: PAR) has received Australian ethics approval for its pivotal Phase 3 clinical trial, PARA_OA_002.
The trial will evaluate the treatment effects of pentosan polysulfate sodium (PPS) against placebo on participants with Knee Osteoarthritis Pain.
The primary endpoint in the pivotal study will be change from baseline at Day 56 in WOMAC pain with secondary outcomes to include change from baseline at multiple time points out to day 168 in WOMAC Pain and Function, Patient Global Impression of Change (PGIC) and Quality of Life (QoL).
CEO, Paul Rennie, said Paradigm has identified eight sites across five States (Vic, WA, Qld, SA and NSW) to conduct the Australian arm of the PARA_OA_002 study, with patient recruitment and screening to commence during Q4.
The company expects to receive a response from the US FDA prior to the end of September, for its Investigational New Drug (IND) application to begin the US arm of the study. ClinicalTrials.gov Identifier: NCT04809376.
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,” Mr Rennie said.
“We expect that, in addition to the 8 Australian sites, there will be clinical sites in UK and Europe and, subject to the FDA’s response, in the US. Our preparation to expand into these additional sites is well underway. Commencing the Phase 3 clinical study is a significant milestone for the company.”
About WOMAC Scores
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. It consists of 24 items divided into three subscales
- Pain (five items): during walking, using stairs, in bed, sitting or lying, and standing upright.
- Stiffness (two items): after first waking and later in the day.
- Physical Function (17 items): using stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy domestic duties, light domestic duties.
About injectable PPS
Injectable PPS is not currently registered in Australia. Injectable PPS for human use is currently only available by inclusion into a Paradigm-sponsored clinical trial or via the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) under limited and specific circumstances.