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.
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.
Many of the commonly used pain medications lack efficacy in the long term and are associated with unwanted side effects.
None of the medications currently available to treat OA address the underlying disease pathology; they do not prevent, stop or restrain progression of OA.
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.
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.
Many of the commonly used pain medications lack efficacy in the long term and are associated with unwanted side effects.
None of the medications currently available to treat OA address the underlying disease pathology; they do not prevent, stop or restrain progression of OA.
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®.
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
- prevents joint degeneration
- reduces the expression of pro-inflammatory mediators
- inhibits the expression and secretion of NGF, a mediator of pain, in the joint
- may improve micro-circulation in the subchondral bone
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.