The cost and complexity of starting with a new molecule is high, encourages iterative progress and reduces the potential for genuine discovery.
Looking for alternative and equally innovative avenues to address unmet needs, Paradigm identified the potential of PPS, an FDA-approved drug that has a long track record of treating inflammation.
PPS was developed in the 1940s, and has been widely used to treat bladder inflammation (interstitial cystitis) and in the EU for preventing deep vein thrombosis.
By working closely with the proprietary manufacturer of PPS, we are able to build upon the substantial knowledge and expertise available from earlier regulatory filings. This includes decades of accumulated toxicology safety data, manufacturing ‘know-how’, and extensive published information about PPS’s mechanisms of action – which primarily involve interactions with proteins impacting inflammation.
With the existing foundation in PPS, Paradigm aims to minimise the risks associated with early-stage drug development.
The optimised timeline for existing chemical entities:
Paradigm’s immediate commercial focus is the development of injectable PPS (iPPS, brand name Zilosul®) for the treatment of osteoarthritis (OA). This is a global unmet need and Paradigm has advanced to phase 3 trials in the space. Addressing all aspects of the disease: inflammation, pain and cartilage regeneration, PPS has genuine disease modifying potential.
Other indications under investigation for PPS include the treatment of joint function, mobility, and pain in patients with mucopolysaccharidoses (MPS); treating alphavirus-induced arthralgia (such as Ross River virus and Chikungunya); chronic heart failure (HF); acute respiratory distress syndrome (ARDS); and allergic respiratory conditions, including allergic rhinitis (AR).
Paradigm continues to progress the development of Zilosul® with the IND (Investigational New Drug) cleared by the US FDA in October 2021.
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IP & Patents
Intellectual property is an important part of Paradigm’s strategic development and ownership of its drug development programs. Paradigm’s PPS has a multi-faceted raft of protection encompassing manufacturing, patents, and exclusive in-licensing and supply, providing protection consistent with composition of matter protection for new indications with unmet clinical needs.
Paradigm works closely with a leading Australian intellectual property firm in the development, registration and prosecution of our patents to secure and maintain a strong IP position.
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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