Pentosan polysulfate sodium (PPS) is a semi-synthetic drug manufactured from the wood chips of European beech trees. Extracted glucurono-xylans are sulfated to produce a negatively charged product that mimics glycosaminoglycans (GAGs).
GAGs are complex carbohydrates that play a regulatory role in the body through interacting with proteins involved with inflammation. Key features of the activity of PPS are its anti-inflammatory and tissue regenerative properties, as well as its mild anti-thrombotic activity.
Due to PPS having multiple mechanisms of action, Paradigm’s broader focus is exploring the use of PPS in the treatment of a wide spectrum of conditions that begin with and are sustained by inflammation, such as osteoarthritis (OA).
Paradigm has a longstanding relationship with bene pharmaChem, the only FDA approved manufacturer/supplier of PPS. Through the extensive interaction and collaboration with bene pharmaChem and Paradigm’s European manufacturers of the injectable formulation of PPS (iPPS), Paradigm has been able to develop its clinical product for trials.
Paradigm has built and sustained strong and successful collaborations with leading clinical researchers and continues to develop partnerships with high-quality European manufacturers in order to bring iPPS to market for the treatment of unmet needs in new clinical indications.
A blockbuster opportunity, PPS (registered as Zilosul®) aims to meet a significant unmet need in osteoarthritis (OA).
There are over 72 million people with OA in key markets (USA, EU5, AU, CAN). In the US alone, OA is predicted to increase by 86% to 67 million people by 2030.
Mechanism of Action
Osteoarthritis (OA) is a disease of the whole joint, leading to and perpetuating inflammation, cartilage degeneration, vascular changes, and pain. We are investigating the potential of PPS to break the cycle of this global unmet treatment need.
To achieve European and FDA approval, PPS has been examined in toxicology and safety studies across several species of animals to humans for more than 50 years. It has been ingested orally, infused in the bladder, injected (IV, intramuscularly and subcutaneously) and administered intranasally in a recent Paradigm toxicology study.
Prior clinical and commercial experience exceeding 22,000 exposures has informed Paradigm’s development program. Our phase 3 study is currently evaluating and identifying the best tolerated and most effective regimen for commercialisation.
Paradigm has registered the trademarks Zilosul® and Rhinosul® for commercialisation of PPS.
Paradigm has an exclusive supply and licence agreement with the only FDA-approved PPS supplier, bene pharmaChem, extending for 25 years post-registration. The agreement covers all markets, ensures scalable manufacturing capabilities, and has been agreed for 25 years from date of marketing approval.
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Heart Failure (HF)
Acute Respiratory Distress Syndrome (ARDS)
Allergic Rhinitis (AR)
Mucopolysaccharidosis I (MPS I)
Mucopolysaccharidosis VI (MPS VI)
The potential of the drug, pentosan polysulfate sodium (PPS) in a broad range of therapeutic areas can be explained by its ability to inhibit multiple biological processes that lead to the development of chronic diseases.
The biological targets of PPS have been described in several peer-reviewed scientific publications.