Paradigm Biopharmaceuticals Ltd (ASX:PAR) is an Australian company focused on repurposing the drug pentosan polysulfate sodium in its injectable form (iPPS), a US Food and Drug Administration (FDA) approved drug that has a long track record of safely treating inflammation.
The biotech company is working on several clinical indications for orthopaedic treatment of OA, BMEL, Ross River virus and Chikungunya and plans to establish commercial partnerships with multiple leading pharmaceutical companies.
A number of clinical trial results are due over the next year, including the phase-2b OA trial due by the end of December.
Paradigm’s drug repurposing strategy will deliver key benefits including lower costs; accelerated development timelines; and higher success rates than the standard clinical development timeline.
1. Khanaoure A, Chuki P & De Sousa A (2014); 2. Ashurn T & Thor K (2004)
Speaking at the company’s annual general meeting in August, Paradigm chairman Graeme Kaufman said there was a global trend for safe and effective non-opioid, non-steroid pain relief for chronic disease such as OA.
Kaufman said: “[This] presents a huge market opportunity for Paradigm’s iPPS.
“Like our OA program, [the Ross River virus program] is also a very exciting commercial opportunity.
“There are currently no registered therapeutics to treat the 10,000 cases of Ross River infections in Australia each year, nor the closely-related alpha virus Chikungunya.
"Chikungunya virus is endemic in many countries and there are millions of cases diagnosed each year again with no registered therapeutics to treat this debilitating disease.”
READ: Paradigm Biopharmaceuticals ‘next Australian blockbuster biotech’, according to Fiftyone Capital
A recent report from Fiftyone Capital said Paradigm was shaping up to be the next major Australian biotech success story, predicting a less than 1% risk of failure for the upcoming OA phase-2b clinical trial.
Provided Paradigm successfully signs licencing deals or commercialises all three of its current indications, the report anticipates a plus-$30 share price and market capitalisation around $5 billion.
It also expects results from the OA phase-2b trial to exceed data from Paradigm’s special access scheme (SAS) which has seen an average pain reduction of more than 50% in 145 patients.
Other indications treatable with iPPS
The Fiftyone Capital report notes the potential to identify other indications that have inflammatory issues as a symptom that could also be treated using iPPS.
Paradigm recently executed an agreement with a US-based medical school for use of its iPPS in the treatment of mucopolysaccharidoses (MPS).
The exclusive in-licence agreement covers the use of iPPS for MPS, a rare inherited disease which causes debilitating joint pain and dysfunction and a key unmet medical need in this class of inherited disease is the lack of treatment.
The company has also entered into a heads of agreement (HoA) regarding a strategic partnership with the New York-based Pro Players’ Elite Network (PPEN) to recruit and treat US-based sportspeople.
The partnership will be under a proposed FDA expanded access program commonly referred to as the ‘compassionate use’ program.
Paradigm views the partnership as an opportunity to not only treat people in need but to gain substantial exposure and promotion of the company and its treatment in the United States.
The US market is a key focus for Paradim given the significant number of OA sufferers – amounting to around 31 million – and in particular the large number of sportspeople and NFL players suffering from OA who are being prescribed opioids for chronic pain management.
Paradigm chief executive officer Paul Rennie said of HoA with PPEN: “Given the success Paradigm has had treating current and retired sportspeople, the company has been actively exploring ways to enter the US.
“Working with past elite sporting organisations such as PPEN allows us to gain access to a range of sportspeople in the US who would be ideal treatment candidates for iPPS.
“Paradigm will be able to work with and leverage the various sporting medical relationships that PPEN has in the US, which can potentially expedite our future US programs.”
The company said it was confident the Therapeutic Goods Administration (TGA) special access scheme results, averaging 51.5% or greater pain reduction for knee pain in 125 patients, will be replicable in the US.
READ: Paradigm Biopharmaceuticals’ positive trial results potentially transformational, says Morgans research
A report from Morgans Financial Limited valued Paradigm in the range of 16 cents to $2.10 a share with a price target of 89 cents, noting an investment in the pharmaceutical company is appropriate for investors with a higher-risk profile.
The report said: “We believe the SAS cases act as a confidence barometer for trial success due in quarter four, calendar year 2018 (of which to date has been extremely successful).
“We view a positive trial result as transformative for the company and will trigger high levels of interest from large pharmaceutical companies, looking to partner through phase III trials and the regulatory pathway.
“Based on the successes of the SAS program to date and subsequent rally in the share price, we believe the market is already factoring in a high chance of success of the OA trial.
“We ultimately view trial success as the most likely scenario based on the strong SAS outcomes … although set our price target on a risk-weighted basis of 38% high case and 62% low case of which the high case representing the average rate of success in phase II trials.”
Paradigm has executed a 20-year exclusive supply agreement with bene PharmaChem GmbH & Co, the original developer and only FDA-approved manufacturer of PPS.
The agreement grants exclusive supply of only FDA-approved PPS for all orthopaedic including alphavirus respiratory and cardiovascular indications.
Under the agreement Paradigm will pay PharmaChem a single digit royalty on commercial sales.
Paradigm has also patented its specific indications to a minimum of 2030, with established regulatory exclusivity and trademarks.
Patent applications have been made for OA and concurrent BMEL, Ross River virus and Chikungunya virus.
iPPS is not currently registered in Australia but is registered in four of the seven major global pharmaceutical markets.
In European markets, iPPS is registered as an antithrombotic agent.
iPPS for human use is not available for sale in Australia and is only available by inclusion into a Paradigm-sponsored clinical trial or via a treating physician applying for its use in patients via the Therapeutic Goods Administration’s SAS category B.