Osteoarthritis

OA

Successful treatment and management of conditions involving inflammation remains a great challenge in modern medicine. There are numerous types of immune and structural cells involved, and the pathways are networked and complex. Osteoarthritis is a key example. It is a chronic disease of the whole joint, leading to and perpetuating inflammation, cartilage degeneration, vascular changes and pain. 1,2

Pharmacological treatment options for OA include pain medications, including topical and oral NSAIDs, and intra-articular injections. Although no longer recommended, many patients progress to opioids if earlier steps do not reduce the pain sufficiently.3,4

Many of the commonly used pain medications lack efficacy in the long term and are associated with unwanted side effects.5 Furthermore, there are strong recommendations against the use of prescription opioids for the treatment of chronic pain in OA, citing harms which clearly outweigh benefits, and low-quality evidence to support their use. Despite this, it is estimated approximately 10% of all opioids prescribed within Australia are for OA pain, with opioids prescribed in 20% of general practitioner visits for hip OA and 10% of visits for knee OA.6 In the US, recent data suggest that more than 800,000 knee OA patients may use opioids chronically for pain management.7

None of the medications currently available to treat OA address the underlying disease pathology; they do not prevent, stop or restrain progression of OA.5

Recognising the pressing need for new, safe, and effective treatments for the symptoms and underlying disease pathology of OA, Paradigm is developing PPS for OA under the trademark, Zilosul®.

Osteoarthritis

OA

Successful treatment and management of conditions involving inflammation remains a great challenge in modern medicine. There are numerous types of immune and structural cells involved, and the pathways are networked and complex. Osteoarthritis is a key example. It is a chronic disease of the whole joint, leading to and perpetuating inflammation, cartilage degeneration, vascular changes and pain. 1,2

Pharmacological treatment options for OA include pain medications, including topical and oral NSAIDs, and intra-articular injections. Although no longer recommended, many patients progress to opioids if earlier steps do not reduce the pain sufficiently.3,4

Many of the commonly used pain medications lack efficacy in the long term and are associated with unwanted side effects.5 Furthermore, there are strong recommendations against the use of prescription opioids for the treatment of chronic pain in OA, citing harms which clearly outweigh benefits, and low-quality evidence to support their use. Despite this, it is estimated approximately 10% of all opioids prescribed within Australia are for OA pain, with opioids prescribed in 20% of general practitioner visits for hip OA and 10% of visits for knee OA.6 In the US, recent data suggest that more than 800,000 knee OA patients may use opioids chronically for pain management.7

None of the medications currently available to treat OA address the underlying disease pathology; they do not prevent, stop or restrain progression of OA.5

Recognising the pressing need for new, safe, and effective treatments for the symptoms and underlying disease pathology of OA, Paradigm is developing PPS for OA under the trademark, Zilosul®.

Key OA Figures

Total prevalence in key markets8,9,10
72 M+
72M+
Knee & Hip % of all OA8
69%
69%
Patients dissatisfied with current treatments11
81%
81%

Key OA Figures

Total prevalence in key markets8,9,10
Knee & Hip % of all OA8
69%
Patients dissatisfied with current treatments11
81%

Drug in development

Pentosan
Polysulfate
Sodium

for subcutaneous injection

Potential

PPS is a strong potential candidate for the treatment of OA, with in-vitro & in-vivo studies suggesting it:

- blocks the effect of cartilage degrading enzymes 12
- prevents joint degeneration 13
- reduces the expression of pro-inflammatory mediators 14,15
- inhibits the expression and secretion of NGF, a mediator of pain, in the joint 16
- may improve micro-circulation in the subchondral bone 17

Remodelling
Inflammation
Pain

Development milestones

The regulatory pathway for PPS has been clarified through multiple meetings with key global regulatory agencies.

In response to feedback from the regulatory agencies Paradigm has conducted 26 preclinical studies to confirm the safety and toxicity leading into the global pivotal trial program.

The pivotal clinical trial programs have commenced in Australia and the US, and will commence in the EU, UK and Canada in 2022.

Paradigm is interested in exploring strategic partnerships for commercialisation of PPS as a treatment for osteoarthritis. For more information and updates, please see our ASX announcements.

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