In parallel to its clinical programs, Paradigm has been pursuing approval for an Expanded Access Program (EAP) to treat the 10 ex-NFL players.
An EAP is similar to Australia’s Special Access Scheme and provides a pathway for patients to gain access to investigational drugs such as Paradigm’s flagship trial drug Zilosul (iPPS).
First patient to be treated in December
The first patient is scheduled to be treated in December 2019 and all ten patients are expected to be treated by the end of the March quarter 2020.
Paradigm’s CEO Paul Rennie said: “Paradigm has made excellent progress with the filing of a number of submissions to the regulatory authorities in the USA, Europe and Australia.
“The FDA Approval of the EAP was a very significant milestone for Paradigm and also an external validation of the safety data.
“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 Dec 2019.
US FDA pre-IND meeting upcoming
In the upcoming pre-IND meeting Paradigm will discuss its clinical, pre-clinical and CMC (manufacturing) data with the US FDA.
The FDA will provide input during this meeting on Paradigm’s data package and Paradigm will comply with the regulator’s request in order to meet the requirements for a successful IND filing to enable the Phase 3 trial and marketing authorisation for NDA filing subsequently.
Rennie added: “The briefing pack to support the US FDA pre-IND meeting has been prepared and is pending submission upon FDA’s confirmation of the meeting date.
“This is another important milestone with the date of the osteoarthritis OA meeting requested to be Q4 CY 2019.
Also progressing discussion in Europe
“Paradigm’s regulatory team is also having discussions with the European Medicines Agency (EMA) re our lead clinical program – osteoarthritis.
“All of these regulatory submissions are evidence of Paradigm’s progression to commercialising iPPS for the global market of more than 200 million OA sufferers6 and Paradigm’s regulatory and clinical expertise to file applications with regulatory authorities in the USA, EU and Australia.”