Clinical data trials being conducted by Paradigm Biopharmaceuticals (ASX: PAR) continue to deliver impressive patient outcomes for sufferers of chronic joint pain and osteoarthritis with 13 new patients having joined the trials and reported significantly better quality of life upon treatment with Zilosul.
The most recent round of trials have been conducted in Australia under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) and draw upon recommendations from the US Food and Drug Administration (FDA) that will accelerate Paradigm’s commercial opportunities.
Specifically, the industry-wide standard of pain assessment – WOMAC scores – has been cleared by the FDA as an acceptable endpoint for Paradigm’s trials where their clinical data identified an average WOMAC reduction of pain by 49.6% from the 89 patients tested under these trials.
Prior to data addition of the 13 most recent patient WOMAC scores, the earlier 76 reported an average WOMAC pain reduction of 47.3% where clinically significant reduction of chronic pain has been defined to be between 25-30% pain reduction.
“It has been pleasing that as we have had additional patient data reported, we have seen consistent reduction in WOMAC pain with each group of patients with average WOMAC pain reduction across the 89-patient cohort being just under 50%,” said Paradigm CEO, Paul Rennie.
“We are seeing consistent clinically meaningful reduction in pain and improvement in joint function in OA patients who have failed to respond to other medications.”
With data from more than 480 patients that have tried Zilosul® in Paradigm’s various clinical trials, the biopharmaceutical company is set to undergo a dual-jurisdiction approach with the aim of commercialising their treatment in both the United States and Australia.
In the US, Paradigm will seek Investigative New Drug (IND) submission to the FDA which if approved will lead to commercial opportunities.
“The focus for Paradigm is firmly on the IND submission this quarter and the initiation and recruitment of our PARA-008 and Pivotal Phase 3 trials,” added Rennie.
“It is very important as Paradigm moves into its Pivotal Phase 3 clinical trial (PARA-002) that we are seeing real world evidence in subjects with knee OA responding in such a positive manner.”
In Australia, Paradigm will take the next step towards registering PPS with the TGA by evaluating biomarkers in Pentosan Polysulfate Sodium treated patients before resuming human trials with Australia. PPS is already registered in four of the seven major global pharmaceutical markets.
Patients participating in the SAS trials were administered with two injections of Zilosul® per week for six weeks, a total of 12 injections.
In the United States, Canada, Europe and Australia which will be Paradigm’s initial target markets, there are more than 72 million people that suffer from osteoarthritis, of why 81% are dissatisfied with current treatments available on the market.
The Western Ontario and McMaster Universities Osteoarthritis Index (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, including pain, stiffness, and physical functioning of the joints.
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