Paradigm Biopharmaceuticals Ltd’s (ASX:PAR) additional data on patients who received Zilosul® under the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS), brings the cumulative average WOMAC reduction in pain from baseline for the 89-patient cohort to 49.6%.
In the 89 patients treated with Zilosul®, 75.3% reported at least a 25% reduction in WOMAC pain with 56.2% of patients reporting a greater than 50% reduction in WOMAC pain, while in subjects with knee OA, it shows a very consistent reduction in pain of nearly 50%.
The cumulative patient data collected includes new data on 13 patients and previously reported data on 76 patients.
The upcoming Phase 3 clinical trial (PARA-002) primary endpoint will assess change in WOMAC pain and WOMAC function from baseline.
The SAS program is expected to commence in the third quarter of 2021, under the pay-for-use program, once the first pivotal study has completed recruitment in Australia.
Consistent reduction in pain
Paradigm chief executive officer Paul Rennie said: “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%.
“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 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.
“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.”
Study outcomes
The 89 patients [50 males, 38 females and 1 unknown with a median age of 57.7 years (29 to 80 years)] had been clinically diagnosed with OA and subchondral BMLs.
At the onset of Pentosan Polysulfate Sodium (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.
Patients were administered with two injections of Zilosul® per week for six weeks (a total of 12 injections).
Patients were followed up at six weeks following the last treatment.
During PPS treatment, patients did not receive NSAIDs or corticosteroid treatment.
The WOMAC pain score, which is a composite of five pain subgroups demonstrated pain reductions across patients in; night-time pain (64.6%); sitting (57.6%), standing (52%), walking on flat surface (48%) and pain on stairs (41.5%).
WOMAC reduction from baseline scores was observed at day 84 or week 12 after the first Zilosul® injection.
Pay-to-use program
The recent data from 89 patients, updates the current patient cohort under the SAS program for patients with Osteoarthritis.
Paradigm treated its first patient under the TGA SAS in December 2015, with the program having treated over 480 patients to date with Osteoarthritis.
Paradigm’s focus will now shift to the initiation and recruitment of Australian patients with Knee OA for PARA-008, which will evaluate biomarkers in PPS treated subjects, and the Pivotal Phase 3 clinical trials for drug registration.
After Phase 3 trial recruitment has completed, Paradigm plans to resume participation in the SAS program for patients with OA.
The market will be updated when pricing for Zilosul® under the Pay-for-Use program has been confirmed.
Pentosan Polysulfate Sodium
Paradigm Biopharmaceuticals is a late-stage drug development company seeking to develop PPS for the treatment of pain associated with musculoskeletal disorders driven by injury, inflammation, aging, degenerative disease, infection or genetic predisposition.