Paradigm Biopharmaceuticals Ltd (ASX:PAR) has entered into a heads of agreement 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 Federal Drug Administration expanded access program, commonly referred to as the ‘compassionate use’ program.
It will aim to identify and assist elite sportspeople that have existing knee and joint pathologies that would benefit from treatment with Paradigm’s injectable pentosan polysulfate sodium (iPPS).
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 osteoarthritis (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 given the success Paradigm has had treating current and retired sportspeople in Australia, the company had been actively exploring ways to enter the US.
He said: “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.
“There is significant common ground between what Paradigm is trying to achieve by being the world’s first non-opioid, non-steroidal, non-addictive effective long-term treatment for chronic joint pain and PPEN’s desire to help combat the opioid problem amongst retired sportspeople and the community at large.”
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.
PPEN has a large network of over 11,000 retired athletes and trusted relationships among the ex-NFL player community, with extensive experience in driving high levels of participation in treatment trials.
Recently the organisation recruited over 150 retired players in a matter of months for a study involving the use of cannabidiol for chronic pain.
PPEN has relationships with the NFL Retired Players Association, the NFL Alumni Association Chapters across the US, Athletes for Care and After the Impact, a non-profit combating opiate addiction.
PPEN chief executive officer Mitch Marrow said: “PPEN will be able to utilise its established contacts and relationships with various NFL retired players and other elite sportspeople organisations, including the NFL Retired Players Association.
“It is well-documented that ex-elite sportspeople, especially football players, have higher rates of joint injuries than members of the general population and therefore are at a higher risk of developing chronic joint pain.
“The PPEN are concerned about the use of opioids to manage chronic joint pain and are passionate about helping people find new treatments for pain that are non-opioid and non-addictive and lead to better past-player welfare.
“The PPEN understands the success that Australian doctors have had, via the TGA Special Access Scheme, in treating Australian Rules Football players as well as people from the general public.”