Melbourne, Oct 10: Paradigm Biopharmaceuticals Ltd (ASX: PAR), a pioneering late-stage drug development company, has unveiled groundbreaking results from its phase 2 PARA_OA_008 clinical trial.
The study demonstrated that a single six-week treatment course of injectable pentosan polysulfate sodium (iPPS) provides long-lasting pain reduction and functional improvement effects throughout a 12-month study period for knee osteoarthritis (OA).
In a medical breakthrough, the data from the PARA_OA_008 trial showcased that iPPS, administered at a dose of 2 mg/kg twice weekly, delivered a durable impact on OA symptoms.
These findings set a new standard in the treatment of OA, a condition that affects millions of people worldwide.
Key Highlights from the PARA_OA_008 Trial:
- 12-Month Duration of Effect: The study demonstrated that patients treated with iPPS experienced significant pain reduction and functional improvement that endured for a full year after just a single six-week treatment course. This duration of effect has not been seen previously in OA treatments.
- Structural Improvements: Beyond pain and function, iPPS also induced positive structural changes in the knee joint. MRI analysis revealed reduced cartilage loss, indicating cartilage preservation, reduced bone marrow lesions, and a decrease in osteophyte formation (bone spurs) in the iPPS treatment groups compared to the placebo.
- Patient-Reported Outcomes: Participants receiving iPPS reported significant improvements in the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) scores, demonstrating better knee pain, function, and stiffness. Additionally, Patient Global Impression of Change (PGIC) scores showed highly statistically significant improvements for iPPS compared to placebo at the 12-month mark.
- Low Rescue Medication Use: The cumulative use of rescue pain medication was over five times higher in the placebo group at Day 365 compared to the iPPS group.
These groundbreaking results highlight the potential of iPPS to revolutionize OA treatment. Paradigm plans to proceed with a Provisional Approval application to the Therapeutic Goods Administration (TGA) based on this data.
Paul Rennie, Managing Director of Paradigm, expressed his enthusiasm, stating, “The 12-month durability of effect on OA pain and function following one 6-week course of treatment is truly an outstandingly positive trial outcome and separates iPPS from all currently available therapies for knee OA.”
Dr. Philip Bloom, Medical Director at Sportsmed Biologic and principal investigator of the PARA_OA_008 trial, emphasized the potential of iPPS as an earlier intervention for maintaining joint health and improving patients’ quality of life.
This promising data positions iPPS as a game-changer in the realm of OA treatments and offers hope to those suffering from this debilitating condition.
Paradigm’s commitment to developing innovative therapies to address unmet medical needs is poised to make a significant impact on the field of osteoarthritis management.
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