Paradigm Biopharmaceuticals (ASX: PAR) has declared that the first patient has been dosed under the FDA-approved expanded access program (EAP) for Zilosul in the US, with first results expected sometime in the third quarter of this year.
The participants in the program will receive two Zilosul injections per week over a six-week period in line with the proposed protocol for the forthcoming phase 3 pivotal study to be discussed with the FDA in an upcoming pre-IND meeting scheduled for later this week.
Paradigm will treat 10 patients comprised primarily of ex-NFL players under the EAP and has previously cited statistics indicating that in males under the age of 60, osteoarthritis is over three times more prevalent in retired NFL players compared to the general US population.
In a statement to the market, Paradigm said it will stagger the commencement of the remaining patient’s treatment over the next four weeks, with the final patient likely to receive their last injection towards the middle of May.
The expanded access program provides a pathway for doctors and patients to gain access to investigational drugs treating patients with serious diseases for which there are no satisfactory therapy options available outside of clinical trials.
Courtesy of the EAP, Paradigm is seeking to provide Zilosul to a limited number of patients that have failed other conservative therapies and who qualify for experimental treatment options.
Commencing US research
According to Paradigm, this milestone marks the first patient treated with Zilosul in the US and maintains the company’s ambition to commence a phase 3 pivotal study.
Eventually, the pharma company hopes to commercialise Zilosul as a potential first-line treatment for knee osteoarthritis.
The data collected from the 10 patients in the extended access program is expected to support the data already collected from the 600-plus patients Paradigm has treated throughout its successful phase 2b clinical trials and accompanying SAS program in Australia.
“We are looking forward to releasing more information in due course about the progress of the pivotal phase 3 study and are hopeful that a positive experience under this EAP will help drive public interest in the forthcoming trials the company expects to conduct in 2020,” said Mr Paul Rennie, chief executive officer of Paradigm.