Paradigm’s iPPS Reduces Key Osteoarthritis Biomarkers in Phase 2 Trial
Paradigm Biopharmaceuticals has secured independent validation of its Phase 2 iPPS biomarker study, published in a leading rheumatology journal, reinforcing the scientific basis for its Phase 3 osteoarthritis trial.
- Phase 2 iPPS biomarker study published in Arthritis Research & Therapy
- Significant reductions in cartilage degradation and inflammation biomarkers
- Durable biological effects observed months after treatment
- Supports ongoing Phase 3 PARA_OA_012 clinical trial
- No serious treatment-related adverse events reported
Independent Validation Bolsters Paradigm’s Osteoarthritis Program
Paradigm Biopharmaceuticals Ltd (ASX, PAR) has achieved a significant milestone with the acceptance and online publication of its Phase 2 injectable pentosan polysulfate sodium (iPPS) biomarker study in the respected international journal Arthritis Research & Therapy. This peer-reviewed publication provides independent scientific validation of the study’s design, methodology, and findings, underscoring the biological activity of iPPS in patients with moderate to severe knee osteoarthritis.
The study, known as PARA_OA_008, was a randomized, double-blind, placebo-controlled trial that explored the effects of iPPS on synovial fluid biomarkers directly linked to cartilage degradation, inflammation, and pain. The publication highlights robust reductions in key biomarkers such as ARGS and C2C, which indicate cartilage breakdown, alongside favourable shifts in inflammatory mediators like TNF-α and IL-6. Notably, these changes were observed within the joint fluid itself, suggesting that iPPS acts at the site of disease.
Biological Effects with Clinical Relevance
Beyond molecular markers, the study also reported improvements in pain-associated biomarkers, including nerve growth factor (NGF), which plays a role in pain sensitisation. These biomarker changes persisted for months after treatment completion, indicating durable biological effects. Clinically, patients receiving iPPS maintained improvements in pain, function, and stiffness over a 12-month follow-up, although the study was not powered to demonstrate definitive long-term efficacy.
Importantly, iPPS was well tolerated with no serious treatment-related adverse events, reinforcing its safety profile. The publication’s acceptance by a journal with an impact factor of approximately 4.6 adds weight to Paradigm’s scientific credibility and supports ongoing regulatory and strategic discussions.
Implications for Phase 3 and Beyond
The biomarker findings from PARA_OA_008 provide mechanistic support for Paradigm’s pivotal Phase 3 trial (PARA_OA_012), which is currently underway. By demonstrating effects on biological pathways central to osteoarthritis progression, namely inflammation, cartilage metabolism, and pain signalling, the study strengthens the rationale for iPPS as a potential disease-modifying treatment.
Paradigm’s Chief Medical Officer, Dr Donna Skerrett, emphasised the collaborative effort behind the study and the importance of the publication in validating the company’s approach. A forthcoming manuscript on MRI imaging outcomes from the same Phase 2 study is expected to offer further insights into structural changes within the joint, potentially enriching the evidence base for iPPS.
As Paradigm continues to advance its clinical program, this publication marks a key step in translating complex biomarker science into tangible progress toward new osteoarthritis therapies.
Bottom Line?
Paradigm’s peer-reviewed biomarker validation sets the stage for pivotal Phase 3 results that could reshape osteoarthritis treatment.
Questions in the middle?
- Will the Phase 3 PARA_OA_012 trial confirm the long-term clinical benefits suggested by biomarker changes?
- How will the upcoming MRI outcomes manuscript influence regulatory and clinical perceptions of iPPS?
- What strategic partnerships or regulatory engagements might Paradigm pursue following this scientific validation?
