Company Interview / Knee-deep in progress: Paradigm's FDA milestone

Paradigm Biopharma gets FDA approval for its phase three trial targeting knee osteoarthritis. Paul Rennie expresses excitement as this validates years of data collection and marks a significant milestone. Recruitment kicks off in Australia before expanding to 80 US centers.

Paul describes the recruitment of 466 subjects for the trial which will span over 10 months, with results expected in 18 months. Emphasis is placed on ethical approval, clinical trial centres, and generating momentum as the trials start in Australia and expand to the United States.

With commercial interest in osteoarthritis growing, Paul mentions ongoing discussions with companies for potential collaboration. Paradigm aims for a new drug application in the US if results align with previous data. Paul is optimistic about rekindling talks with commercial partners now that FDA clearance is secured.