Regulatory progress means Paradigm Biopharmaceuticals will treat ex-NFL players with Zilosul later this year

Paradigm Biopharmaceuticals ASX PAR regulatory progress iPPS Zilosul
Following regulatory approvals, Paradigm Biopharmaceuticals will treat former NFL players in the US before the end of March 2020.

Paradigm Biopharmaceuticals (ASX: PAR) has been given the go-ahead by US regulators to treat 10 former NFL players with its pentosan polysulfate sodium (iPPS) drug, otherwise known as Zilosul.

Following the successful US Food and Drug Administration approval of the Expanded Access Programme (EAP), Paradigm has announced that the Institutional Review Board (IRB) has also cleared the treatment 10 ex-NFL players under the EAP.

Around this time last year, Paradigm signed a strategic head of agreement 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.

At the time, the view was that by assisting elite sportspeople with existing knee and joint pathologies, the company could validate its Zilosul drug in a real-world environment.

In parallel, Paradigm was also involved in a similar program in Australia by treating AFL players.

Today’s news that Paradigm has been approved by the IRB in the US – an FDA-approved agency with the authority to approve biomedical research – means the biopharmaceutical company has a clear pathway to make progress in the US, currently the world’s largest healthcare market.

In a statement, the company confirmed that it is about to ship Zilosul from its European warehouse with the first patient scheduled to be treated in December 2019 and all 10 patients are on track to be treated by the end of March 2020.

Regulatory spree

In addition to treating former NFL players, Paradigm has also filed a pre-investigational new drug meeting request with the FDA which will allow the company to present its clinical, pre-clinical and manufacturing data to the US regulator.

The company is hopeful that this will open the door to advancing towards further clinical research in the form of a phase 3 trial.

Paradigm said that it has requested a meeting before the end of this year and expects to receive feedback by the end of October regarding the acceptance of proposed dates, or, alternatively, for the FDA to stipulate alternative dates.

“The FDA approval of the EAP was a very significant milestone for Paradigm and also an external validation of the safety data,” said Paul Rennie, chief executive officer of Paradigm.

“The IRB approval is another important validation, and this now clears the way forward for Dr Michel to commence the treatment of the first patient which is scheduled for December 2019,” he added.

Parallel European development

Aside from the US, Paradigm is keen to develop Zilosul for the European market.

The biopharma company declared that it is preparing for a scientific advice meeting with the European Medicines Agency (EMA).

In the same vein as in the US, Paradigm must present its osteoarthritis program to European regulators to ensure clinical, pre-clinical and manufacturing packages contain all the necessary information to cover any requirements, to ensure easier clinical trial application and marketing authorisation filings at subsequent dates.

Paradigm said it plans to file an application in late December 2019 or early January 2020.

Back in Australia

In Australia, Paradigm’s approval process has now been “expedited” due to a new approval procedure that covers promising new therapeutic products such as Zilosul.

The provisional approval pathway allows sponsors to apply for provisional registration on the Australian Register of Therapeutic Goods (ARTG) for certain promising new medicines in diseases that are determined to be serious.

Paradigm submitted a meeting request for provisional approval to the Therapeutic Goods Administration on 29 August 2019 and was granted a meeting date of 11 November 2019.

According to Paradigm, the key objective of this meeting is for Paradigm to present its iPPS program to the TGA for osteoarthritis and to confirm that it meets the criteria for “unmet need”.

If Paradigm is successful in obtaining provisional approval from the TGA, it would be permitted to market and sell Zilosul for the treatment of osteoarthritis in Australia and thereby could be generating revenue as early as Q3 2020.

With regulatory progress on track, Mr Rennie stated that all regulatory filings were “going very well, are on schedule and on budget.”

Global problem

According to the Osteoarthritis Research Society International (OARSI), osteoarthritis is a “major worldwide challenge” that is increasing in prevalence on a global scale.

The agency said that the condition ranks as the 10th leading contributor to global disability with supplemental catalysts such as demographics and obesity rates compounding the effect of osteoarthritis on society.

In 2005, almost 27 million US adults were estimated to have osteoarthritis, up from 21 million in 1990.

Furthermore, the trends in osteoarthritic disabilities from 1990 to 2013 showed a 75% increase, the third most rapidly rising condition associated with disability – second only to diabetes at 135% and dementia at 84%.

The most recent update by the Global Burden of Disease figures estimated that 242 million people were living in the world with symptomatic and activity limiting osteoarthritis of the hip and/or knee.

“All of these regulatory submissions are evidence of Paradigm’s progression to commercialising iPPS for the global market of more than 200 million osteoarthritis sufferers and Paradigm’s regulatory and clinical expertise to file applications with regulatory authorities in the USA, EU and Australia”, said Mr Rennie.

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