Paradigm Biopharmaceuticals Ltd's (ASX:PAR) additional data from patients who received Zilosul® under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) reveals continuing reduction in pain associated with knee osteoarthritis (OA).
The data on an additional 42 patients brought the cumulative average WOMAC reduction in pain from baseline for the 76-patient cohort to 47.3%.
In the 76 patients treated, 73.7% reported at least a 25% reduction in WOMAC pain with 52.6% of patients reporting a greater than 50% reduction in WOMAC Pain.
Paradigm chief executive officer Paul Rennie said: “As we progress toward regulatory submissions for Paradigm’s proposed Phase 3 global study, its pleasing to receive consistent patient WOMAC pain reduction outcomes through the TGA Special Access Scheme.”
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“Meaningful reduction in pain”
At the onset of PPS treatment patients were symptomatic with OA pain for at least six months and had failed current standard of care, which involved treatment with analgesics, NSAIDs (non-steroidal anti-inflammatory drugs) or corticosteroids.
Rennie said: “Consistency is key here.
“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.”
The 76 patients [43 males, 32 females and 1 unknown with median age of 57.7 years and range of 29 to 76 years] had been clinically diagnosed with OA and subchondral BMLs.
Baseline WOMAC pain scores are recorded prior to commencing the six-week treatment program where each patient receives 2 milligrams/kilogram of Zilosul® twice weekly.
Patients were followed up at six weeks following the last treatment and during the course of PPS treatment, patients did not receive NSAIDs or corticosteroid treatment.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score is a composite of five pain subgroups demonstrated pain reductions across patients in; night-time pain (63.7%); sitting (56.1%), standing (49.8%), walking on flat surface (45.6%) and pain on stairs (39.1%).
A WOMAC reduction from baseline scores were observed at day 84 or week 12.
Paradigm’s primary endpoint in the upcoming Phase 3 trial design will be a reduction in pain and function from baseline using the WOMAC index.
The average WOMAC pain reduction (5 items) for 76 patients treated with iPPS under the TGA SAS
Patient global impression of change
Patient Global impression of Change (PGIC) is a self-reported measure that reflects the patient’s belief about the overall efficacy of the treatment.
A total of 76% (58 out of 76) of SAS patients had reported Patient global impression of Change (PGIC) of moderately to definite and considerable improvement in their OA condition with iPPS (Zilosul®) treatment.
Paradigm’s Phase 3 trial will include an improved PGIC as an endpoint.
The company expects to report on further patients receiving Zilosul® treatment under the SAS program in quarter four 2020.
Rennie said: “Paradigm remains primarily focused on our upcoming submissions to the multiple regulatory agencies as we continue to progress toward commercialisation.
“Again, I would like to thank all the doctors who have aided Paradigm in collecting the important patient data from the Special Access Scheme.”