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Paradigm Osteoarthritis Study Data Accepted for Poster Presentation at OARSI World Congress on Osteoarthritis

Paradigm Biopharmaceuticals Ltd. logo. The word 'PARADIGM' in dark grey blending to rose and purple over the word 'PHARMA' in mid grey

Day 56 results from the phase 2 synovial fluid biomarker clinical trial in osteoarthritis will be presented at the 2023 OARSI World Congress on Osteoarthritis.

Paradigm Biopharmaceuticals Ltd. (ASX:PAR)

To have our exciting data from this phase 2 clinical trial evaluating the disease modifying potential of iPPS selected for presentation at a global OA conference is a fantastic outcome”
— Paul Rennie

MELBOURNE, VICTORIA, AUSTRALIA, December 8, 2022 /EINPresswire.com/ -- Paradigm Biopharmaceuticals Ltd (ASX:PAR, “Paradigm” or “the Company”), a late-stage drug development company focused on delivering new therapies to address unmet medical needs, is pleased to report the abstract detailing the day 56 results from the phase 2 synovial fluid biomarker clinical trial (PARA_OA_008) has been accepted for a poster presentation at the 2023 Osteoarthritis Research Society International (OARSI) World Congress on Osteoarthritis.

The annual OARSI Congress is the pre-eminent multidisciplinary global forum to showcase and display cutting-edge OA research from academia and industry worldwide. The global conference will be held in Denver, Colorado, from 17–20 March 2023.

Paradigm submitted an abstract titled “An exploratory, phase 2 clinical trial in knee osteoarthritis subjects suggests therapeutic effects of pentosan polysulfate sodium on synovial fluid biomarkers of pain, inflammation and chondroprotection”, which has been reviewed by the OARSI panel and accepted for a poster presentation over two sessions during the conference. Dr Mukesh Ahuja, Paradigm’s Global Clinical Head of OA, will be presenting the poster on Paradigm’s behalf and will conduct a Q&A throughout the two sessions.

Paradigm will also be conducting a sponsored oral theatre presentation to OARSI conference attendees. The presentation will cover Paradigm’s OA program, including the day 56 top-line data from the PARA_OA_008 clinical trial and proposed mechanism of action of injectable pentosan polysulfate sodium (iPPS) in osteoarthritis (OA).

Paradigm Managing Director, Mr Paul Rennie said: “To have our exciting data from this phase 2 clinical trial evaluating the disease modifying potential of iPPS selected for presentation at a global OA conference is a fantastic outcome for the Company and all Paradigm shareholders. It provides further validation that the data on iPPS treatment in knee OA patients is truly world class and is being recognised by a global audience of our peers”.

PARA_OA_008 Day 56 Top-line Results Highlights
• Primary endpoint relating to synovial fluid biomarkers achieved and positive top-line results reported for the PARA_OA_008 phase 2 clinical trial (n=61).
• Several OA biomarkers analysed were observed to favourably change over time in patients treated with iPPS compared to placebo. These biomarker changes provide insight into iPPS mechanisms of action as well as signals of disease modifying potential.
• iPPS was associated with positive changes for several chondroprotective biomarkers.
• Additionally, iPPS-treated subjects demonstrated statistically significant improvement in WOMAC pain, function, and stiffness scores at day 56 for the twice-weekly group compared to placebo.
• In Para_OA_008, the mean percentage change from baseline in WOMAC pain is 50% compared to 30%, p=0.05 for twice-weekly iPPS versus placebo, respectively. The mean percentage change from baseline in WOMAC function is 50% compared to 25%, p=0.017 for twice-weekly iPPS compared to placebo, respectively.
• Of the 61 patients, 48 (78%) had KL grades 3-4, indicating moderate to severe OA.

View entire PARA_OA_008 release.

About Paradigm Biopharmaceuticals
Paradigm Biopharmaceuticals Ltd. (ASX:PAR) is a late-stage drug development company driven by a purpose to improve patients’ health and quality of life by discovering, developing, and delivering pharmaceutical therapies. Paradigm’s current focus is developing injectable (subcutaneous) pentosan polysulfate sodium (iPPS) for the treatment of diseases where inflammation plays a major pathogenic role, indicating a need for the anti-inflammatory and tissue regenerative properties of PPS, such as in osteoarthritis (phase 3) and mucopolysaccharidosis (phase 2).

Authorised for release by the Paradigm Board of Directors.
To learn more please visit: www.paradigmbiopharma.com

Simon White
Paradigm Biopharmaceuticals Ltd.
+61 404 216 467
investorrelations@paradigmbiopharma.com
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