The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is on the move this Friday. This comes after the biopharmaceutical company provided an update in regards to its upcoming clinical trial.
At the time of writing, Paradigm's shares are fetching for $2.12, up 3.41%.
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What did Paradigm announce?
In today's statement, Paradigm advised it has received an Australian ethics approval for its pivotal phase 3 clinical trial, PARA_OA_002.
The study will see the treatment of pentosan polysulfate sodium (PPS) against placebo on participants with Knee Osteoarthritis Pain.
PPS, an injectable solution, aims to treat musculoskeletal disorders caused by injury, inflammation, aging, degenerative disease, infection or genetic predisposition. The semi-synthetic drug is packaged as Zilosul and has shown improvements in pain reduction, joint function, and the prevention of cartilage damaging joints.
Evaluation will be done through WOMAC pain and WOMAC function at multiple time points from day 1 to day 168.
WOMAC is a widely-used health tool that assesses physical function, pain, and stiffness in patients with Osteoarthritis. The self-administered instrument gives a score range for each of the three subclasses to indicate the patient's health status.
Paradigm is eyeing 8 sites across 5 states in Australia to conduct its PARA_OA_002 study. The states include Victoria, Western Australia, Queensland, South Australia and New South Wales.
Patient recruitment and screening are set to commence during the fourth quarter of the calendar year.
In addition, the company expects to receive a response this month from the United States Food and Drug Administration. This is in relation to its Investigational New Drug (IND) application to begin the United States arm of the study.
Management commentary
Paradigm CEO, Paul Rennie said:
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. 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.
Paradigm share price snapshot
The Paradigm share price has been up and down over the past 12 months, reaching as high as $3.19 and as low as $1.76. While losing around 10% in value since this time last year, its shares are down further by 20% in 2021.
Paradigm commands a market capitalisation of roughly $465.82 million and has approximately 229.91 million shares on its registry.
