The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is racing higher during early afternoon trade on Thursday.
This comes after the biopharmaceutical company provided an update on its pivotal phase 3 clinical trial.
At the time of writing, the Paradigm share price is $1.29, up 4.88%.
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What did Paradigm announce?
In today's statement, Paradigm said the first subjects in the PARA_OA_002 clinical trial have been randomised and dosed in the United States.
The study's objective is to evaluate the treatment of pentosan polysulfate sodium (PPS) 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. It has been shown to reduce pain, improve joint function, and prevent cartilage damaging joints.
Paradigm noted that the first subject randomisation occurred at Northwestern University in Chicago. It was conducted by lead investigator Dr Thomas Schnitzer.
The PARA_OA_002 study is currently enrolling subjects at eight sites in Australia and 21 sites in the US. In addition, locations in the United Kingdom and Europe are expected to be initiated in 2022.
Paradigm will evaluate study participants using WOMAC pain and WOMAC function at multiple time points from day 56 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.
Management commentary
Paradigm chief medical officer and interim CEO Dr Donna Skerrett said:
To have our first subjects randomised in the US is an important milestone in the OA clinical program.
The Paradigm clinical team has been working tirelessly to initiate and activate sites throughout the US and we are seeing a large number of subjects entering the screening phase throughout the US.
We look forward to continuing the strong momentum in the phase 3 program and reporting important recruitment milestones to our shareholders.
Paradigm share price snapshot
From November 2021, the Paradigm share price has been on a trending decline.
Paradigm shares hit an all-time low of 92.5 cents last month and have since moved in a sideways channel.
While falling 44% over the past 12 months, the bulk of these losses have come in 2022 — down 32%.
Based on valuation grounds, Paradigm commands a market capitalisation of roughly $286.19 million.
