Paradigm Biopharmaceuticals looks to touchdown its osteoarthritis drug in the United States

Paradigm Biopharmaceuticals ASX PAR Pro Players Elite Network NFL athletes
Over 31 million people suffer from osteoarthritis in the United States alone, including a high number of retired professional athletes.

Paradigm Biopharmaceuticals (ASX: PAR) has struck a strategic partnership with the Pro Players’ Elite Network (PPEN), a US-based retired professional sporting network comprised of over 11,000 retired NFL players and elite athletes.

The biopharmaceutical company said the heads of agreement signed between Paradigm and the PPEN was a “logical step forward” and aims to identify and assist elite US sportspeople that have existing knee and joint pathologies – precisely its target audience who could benefit from treatment with injectable Pentosan Polysulfate Sodium (iPPS), the company’s leading product already being trialled by AFL players in Australia.

Currently, Paradigm is repurposing iPPS, an FDA-approved drug with a proven track record of safely treating inflammation and dissolving blood clots for over 60 years.

The company said growing the number of patients it treats with iPPS would further expand its chances of delivering breakthrough treatment options for leading athletes but would also provide significant exposure of its industry-beating drug to a global audience.

The US market is a key focus for Paradigm, given the estimated 31 million people currently suffering from osteoarthritis (OA), and in particular, the large number of athletes and NFL players suffering from OA who are currently being prescribed opioids to treat chronic pain – a treatment option that often has unwanted complications and detrimental long-term effects for patients.

As part of its bid to increase coverage of its iPPS product, Paradigm said PPEN would facilitate greater use of iPPS via its strong relationships with the NFL Retired Players Association (NFRPA), the NFL Alumni Association Chapters across the US (NFLAA), ‘Athletes For Care’, and ‘After the Impact’, a non-profit organisation focused on combatting opiate addiction with numerous top NFL ‘Hall of Famers’ and US Generals sitting on its various committees and boards.

According to Paradigm, the PPEN network membership brings with it strong inter-network relationships consisting of high profile ex-players, “which will bode well for working with prominent sports clinics and hospitals in the New York area.”

Supporting ongoing trials in Australia

Paradigm is currently advancing a clinical program for iPPS in Australia with over 125 athletes already using the drug to reduce chronic pain.

So far, seven AFL clubs have taken advantage of the new treatment, currently being used by 40-50 former and current AFL players with reportedly “outstanding” results.

In the 125 patients treated, 85.6% responded with a reduction in joint pain and 91.2% an improvement in knee function.

Paradigm has sequentially added patients to its clinical program with pain reduction scores remaining consistently higher than similar drugs being marketed by other, typically larger, pharmaceutical companies.

“With pain reduction of more than 50% across 125 osteoarthritis patients the data from the TGA special access scheme continues to underpin the potential for our pentosan treatment. With two phase 2 clinical trials reading out before the end of 2018 it is an exciting and pivotal time for the company,” said Paradigm managing director Paul Rennie.

Capital boost

In order to maintain its excellent stretch of results and continue its strong run towards its next milestone – a phase 3 clinical trial program –  Paradigm raised $9 million as part of a placement to professional, institutional and sophisticated investors across Australia and Asia.

The funds are intended to finalise its clinical program and to accelerate the timeline to the commencement of Paradigm’s anticipated phase 3 trial of its osteoarthritis treatment.

Additionally, the money will be used to establish a presence in the US and to fund a “compassionate use program” involving the US Pro Players Elite Network.

Paradigm has also confirmed that it remains on track to announce the read out from its Phase 2B 110 patient trial in mid-December 2018.

“Given the success we have had treating both current and retired sportspeople in Australia, Paradigm has been actively exploring ways to enter the US and provide greatly needed treatments to US past elite sportspeople,” said Mr Rennie.

“Working with past elite sporting organisations, such as the Pro Players Elite Network, allows us to gain access to a range of sportspeople in the US who would be ideal treatment candidates for iPPS and this, in turn, will provide valuable Real-World Evidence for Paradigm.”

“In addition, Paradigm will be able to work with and leverage the various sporting medical relationships that the Pro Players Elite Network has in the US, which can potentially expedite our future US programs,” added Mr Rennie.

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