- Paradigm Biopharmaceuticals (PAR) activates its first trial site in the United Kingdom for a third-phase trial of its Zilosul treatment for knee osteoarthritis
- The news comes after the company received UK regulatory and ethics approvals to proceed with the phase three clinical trial
- Paradigm plans to activate seven sites altogether across the UK, with the remaining locations due to be launched in the coming months
- Meanwhile, the company’s same clinical trial has received regulatory approval from Health Canada, joining its previous approvals from the US FDA and the Australian TGA
- Paradigm Biopharmaceuticals last traded at $1.05 on July 5
Paradigm Biopharmaceuticals (PAR) has activated its first trial site in the United Kingdom for a third-phase trial of its Zilosul treatment for knee osteoarthritis (OA).
The news comes after the company received UK regulatory and ethics approvals to proceed with the phase three clinical trial.
The study aims to measure the change in pain and function of patients with OA following injections of pentosan polysulfate sodium (PPS), compared with subcutaneous injections of placebo.
With the first site at the University of Leeds now active, Paradigm said it would look to begin participant screening and enrolment imminently.
Paradigm plans to activate seven sites altogether across the UK, with the remaining locations due to be activated in the coming months.
Meanwhile, the company’s same clinical trial has received regulatory approval from Health Canada.
An ethics submission was made to the research ethics board in Canada, with approval still pending. Once the company gains the approval, Paradigm said it will begin setting up clinical sites and enrolling patients for the study, with up to ten testing sites to be activated across the North American country.
The phase three trial now holds approvals from the US FDA, the UK Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, and the Australian TGA.
Paradigm Chief Medical Officer Donna Skerrett said the company was pleased to be moving forward with regulatory approval within another planned jurisdiction for the program.
“The interaction with Health Canada was positive throughout the regulatory process, and the company looks forward to announcing anticipated ethics approval and subsequent participant recruitment in Canada,” Dr Skerrett said.
“Equally, the achievement by the Paradigm team to activate participant recruitment in the UK highlights Paradigm’s ongoing execution of activities for this global phase three trial in knee OA.”
Paradigm Biopharmaceuticals last traded at $1.05 on July 5.