AT A GLANCE

Paradigm Biopharmaceuticals

Paradigm Biopharma is a drug repurposing company.

Our approach to market is driven by core competencies and experience at both board and executive level in clinical and commercial pharmaceutical development.

Over 30% of new drugs or biologics approved or launched globally represent drugs repurposed for new indications, reformulations or new combinations of existing drugs.

Our approach is to take an existing approved drug, which has demonstrated safety in its approved indication/s and repurposing that drug in a new patented therapeutic application.

By following this approach, we achieve a reduction in the time, cost and risk associated with the clinical and commercial development pathway to taking new products to market.

Paradigm Biopharma primary focus to date is its pipeline indications covering the use of pharmaceutical compound Pentosan Polysulfate Sodium (PPS), supported by full patent and IP protection.

Our immediate commercial focus is the repurposing of PPS for the treatment of Osteoarthritis (OA). This is a global unmet need and we have advanced to phase 3 trials in the space. Addressing all aspects of the disease: inflammation, pain and regeneration, PPS has genuine disease modifying potential.

A key feature of the activity of PPS is its anti-inflammatory and tissue regenerative properties, and our wider focus is exploring its use in the treatment of the myriad conditions that begin with and are sustained by inflammation.

Other indications include the treatment of joint function, mobility and pain in patients with mucopolysaccharidoses (MPS), chronic heart failure (CHF), treating alphavirus induced arthralgia (in patients with Ross River Virus and Chikungunya); and allergic respiratory conditions, including allergic rhinitis (AR) and chronic obstructive pulmonary disease (COPD).

Adopting an intelligent and agile approach to clinical research and development, our experienced team are passionate in our commitment to the quality of our programmes. We have built and sustained strong and successful collaborations with leading clinical researchers in the field and continue to develop partnerships with high quality European manufacturers in order to bring new, effective treatments to market.

Re-pioneering molecules

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 had been used narrowly to treat bladder inflammation (interstitial cystitis) and for preventing deep vein thrombosis.

By working closely with the proprietary manufacturer of PPS, we are now 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 involved interactions with proteins impacting inflammation.

With the foundation we have in drugs such as PPS, Paradigm Biopharma minimises its risk profile as an early stage drug development company.

We are already seeing shortened drug development cycle time for our chosen applications and development costs are minimised.