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- Paradigm Biopharmaceuticals (PAR) has received results supporting the effectiveness of Zilosul in reducing osteoarthritis pain in the knees
- So far, results are available from 76 patients who received Zilosul under the Therapeutic Goods Administration’s (TGA) Special Access Scheme
- Overall, chronic pain was reduced by 47.3 per cent when measured on the WOMAC pain score, which incorporates five pain subgroups
- The treatment continues to be well-tolerated by patients and further results from patients receiving the treatment under the Special Access Scheme are expected later this year
- Shares have been trading six per cent higher for $2.81
Paradigm Biopharmaceuticals (PAR) has received results supporting the effectiveness of Zilosul in reducing osteoarthritis pain in the knees.
The company received results from 34 patients in April and has now received data from another 42. This brings the total cohort of patients who received Zilosul under the Therapeutic Goods Administration’s (TGA) Special Access Scheme to 76.
Overall, chronic pain was reduced by 47.3 per cent when measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score.
WOMAC is based on a set of standardized questionnaires and is widely used to evaluate the condition of patients with osteoarthritis. The pain score incorporates pain during walking, using stairs, in bed, sitting or lying and standing upright.
Across these subgroups, patients experienced a reduction in pain of 63.7 per cent in night-time pain, 56.1 per cent when sitting, 49.8 per cent when standing, 45.6 per cent when walking on a flat surface and 39.1 per cent when using stairs.
Paradigm CEO Paul Rennie said the data is encouraging as it aligns with a primary endpoint of the company’s proposed phase three trial.
“As we progress toward regulatory submissions for Paradigm’s proposed phase three global study, its pleasing to receive consistent patient WOMAC pain reduction outcomes through the TGA Special Access Scheme.”
“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,” he added.
The proposed primary endpoints for the trial will be reduced WOMAC pain from baseline and improved Patient Global Impression of Change at week eight, or day 53.
The treatment continues to be well-tolerated by patients and the company expects to report on further results later this year.
Shares have been trading six per cent higher for $2.81 at 12:00 pm AEST.
