- Data from an additional 13 patients who received Paradigm Biopharmaceuticals’ (PAR) osteoarthritis treatment has shown a clinically significant reduction in pain, consistent with previous data
- A total of 89 patients have received Zilosul under the Australian Therapeutic Goods Administration (TGA) Special Access Scheme
- Chronic pain was measured using WOMAC pain scores, a composite of five pain subgroups, and demonstrated a mean reduction in pain of 49.6 per cent, including a 64.6 per cent reduction in night-time pain
- Paradigm will begin enrolment for its phase three pivotal trials of Zilosul, needed for drug registration, after which it will rejoin the TGA’s special access scheme
- Shares have been trading 4.4 per cent higher at 11 cents
Data from an additional 13 patients who received Paradigm Biopharmaceuticals’ (PAR) osteoarthritis treatment has shown a clinically significant reduction in pain.
The data is consistent with that previously reported from 76 earlier patients to receive Zilosul under the Australian Therapeutic Goods Administration (TGA) Special Access Scheme.
Chronic pain was measured using the WOMAC pain score, which is a composite of 5 subgroups: during walking, using stairs, in bed, sitting or lying, and standing upright.
A clinically significant reduction in pain is defined as a decrease in pain in the range of 25-30 per cent, yet the mean reduction in the patient cohort to be treated with Zilosul was 49.6 per cent.
Across the pain subgroups, the area of greatest relief was in night-time pain which fell 64.6 per cent.
“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 per cent,” said 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,” he continued.
“The focus for Paradigm is firmly on the IND [Investigational New Drug] submission this quarter and the initiation and recruitment of our PARA-008. 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.”
The company has already met with the U.S. Food and Drug Administration to receive guidance on its trial design necessary for the IND submission.
Shares have been trading 4.4 per cent higher at 11 cents at 10:14 am AEDT.