Drug development company Paradigm Biopharmaceuticals [ASX:PAR] reported positive results for one of its clinical trials focused on osteoarthritis (OA).
PAR shares rose more than 15% on a green day for the ASX following a dovish interest rate hike from the Reserve Bank of Australia (RBA).
Despite today’s spike, PAR shares are down 20% year to date.
Source: Trading View
Positive results for OA research
PAR shares surged on Tuesday after the drug developer reported positive clinical trial results for its injectable PPS PARA_OA_008 phase II clinical trial.
The trial evaluates the treatment effects of injectable pentosan polysulfate (iPPS) on synovial fluid biomarkers associated with osteoarthritic pain and inflammation.
PAR endeavours to develop a Disease-Modifying OA Drug (DMOAD) that will ‘alter the natural history of disease progression by arresting joint structural change and ameliorate symptoms, either by reducing pain or improving physical function’.
The company collected data over a 56-day period, analysing synovial fluid biomarker changes from baseline for iPPS patients suffering from OA.
On day 56, the company reported all patients were displaying signs of favourable synovial biomarker changes in comparison with placebo controls.
PAR reported ‘positive top-line results’, elaborating:
‘The day 56 data analysed by an independent clinical research organisation, demonstrates synovial fluid biomarker change from baseline for the iPPS treatment group. iPPS impacted multiple biomarkers measured in the synovial fluid. Reductions in nerve growth factor (NGF) indicate iPPS mechanisms related to pain reduction. Reductions in TNF-α and IL-6 indicate mechanistic effects on inflammatory pathways.
‘Reductions in COMP and ARGS and an increase in TIMP-1 provide important insights into iPPS mechanisms of action impacting cartilage preservation and potential disease modification. In all cases, the synovial biomarker changes in iPPS-treated subjects at day 56 were favourable compared to placebo controls. WOMAC data has also been collected from baseline. iPPS treatment showed statistically significant improvements at day 56 in pain, function, stiffness, and overall WOMAC scores for twice-weekly iPPS compared to the placebo arm. The proportions achieving ≥30% and ≥50% improvement in pain were 73% and 60%, respectively.’
PAR seeks to close the OA gap
Paradigm said Global Market Intelligence has found that people suffering from OA in the US are likely to pay between US$2,000 and US$3,000 annually for iPPS treatment to reduce pain and knee-functionality issues.
If the FDA were to approve the models, therapy prices in the US could skyrocket beyond US$6,000.
PAR said:
‘Further underlining the economic burden, an additional comprehensive study estimated that in 2013, total US arthritis-attributable medical expenditures reached almost $US140 billion, which when combined with wage losses, totalled losses of over $US303 billion.’
Paradigm’s CEO Marco Polizzi said:
‘Achieving the primary endpoint with consistent significant reductions in pain in iPPS-treated patients compared to placebo is an outstanding milestone for the Company. The top-line results are encouraging at day 56 and we look forward to further data at 6 and 12 months. The biomarker changes following iPPS, the statistically significant signals that we are observing in the WOMAC scores along with the safety and tolerability of iPPS in this exploratory study, will be valuable in discussions with regulatory bodies (FDA and TGA) and commercial partners.’
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