Paradigm doses all trial patients with Zilosul while dodging COVID-19 impact
The FDA’s Extended Access Program remains “on-track” with Paradigm expecting to report results in Q3 2020.
An experimental treatment for knee osteoarthritis developed by Paradigm Biopharmaceuticals (ASX: PAR), Zilosul, has now been dosed in all ten patients under the FDA approved expanded access – otherwise known as compassionate use – program in the US.
In a statement to investors, Paradigm said patients being treated are at different stages of the treatment cycle, with the last patient in the program receiving their final dose just yesterday.
Importantly, the company reassured investors and market analysts by saying its program was “unaffected” by the ongoing COVID-19 pandemic thereby avoiding a setback in scheduling for both patients and the company.
Addressing the impact of COVID-19, Paradigm stated: “the company does not believe the impact from COVID-19 is material to the overall business operations at this time due to the fact no clinical trials are being undertaken and the majority of Paradigms staff already work remotely.”
Forging ahead
Paradigm stipulated that it is actively monitoring the progression of each patient and noted “consistent positive feedback” from patients as they undergo their course of treatment.
The ten patients being treated under the FDA program have all failed to benefit from various other treatments for knee osteoarthritis, and thus far, have provided positive feedback about the early effects of Zilosul.
“As a former professional of the National Football League and now active Alumnus, I’ve suffered with OA [osteoarthritis] since later in my playing days and understand first-hand the debilitating effects of how it can affect a person’s life,” said Thomas Everett, former NFL safety and two-time Super Bowl champion, currently undergoing treatment under the FDA program.
“I have tried pretty much all traditional treatment available without a ton of success, so I am absolutely thrilled and very excited to be part of a study that could actually treat the underlying ailment and not just the symptoms,” he said.
Another patient in the program, Richard Van Druten, formerly of current champions Kansas City declared that he had “recently started walking comfortably and even jogging for the first time in many years”.
Anecdotal evidence from early patients in the US combined with positive reports from AFL athletes suggests Zilosul could become a commercially viable drug that is marketed globally.
In past studies, Paradigm’s drug reduced joint pain and improved knee function in 84.4% of patients as part of the company’s TGA-approved special access scheme in Australia.
According to Paradigm, each patient in the program was screened and assessed to measure their baseline pain scores including detailed MRI scans to determine the presence of bone marrow edema lesions (BMEL) within the knee joint.
Bone marrow edemas occur due to fluid build-up in the bone marrow, which tend to occur as a response to an injury such as a fracture or conditions such as osteoarthritis.
Paradigm plans to conduct follow-up scans and pain measurements 6 weeks after treatment is completed before reporting its results in Q3 of 2020.
“We continue to be encouraged by the anecdotal feedback from each patient as they progress through the treatment cycle and look forward to presenting the results to the market once available,” said Paul Rennie, chief executive officer of Paradigm Biopharmaceuticals.