EMA PROVIDES KEY PATH TOWARD PHASE 3 TRIALS AND REGISTRATION

PARADIGM’S CLEAR PATH TOWARDS ZILOSUL’S OA
PHASE 3 CLINICAL TRIAL AND PRODUCT REGISTRATION
IN EUROPE.

KEY HIGHLIGHTS FROM SCIENTIFIC ADVICE MEETING WITH EMA:
• Positive feedback received from European Medicines Agency (EMA) after Paradigm’s
recent Scientific Advice meeting.
• This is a key regulatory milestone for Paradigm, which supports and validates our clinical
development to date and our commercialisation plans for Zilosul® in Europe.
• Based on this feedback applications to commence clinical trials in EU member countries
can now begin, with a clear path to product registration.
• EMA agreed with the primary endpoint to evaluate WOMAC pain and WOMAC function.
• EMA confirmed no active comparator required and Zilosul® will be evaluated against a
saline placebo arm.
• Paradigm is in the process of seeking advice on the phase 3 clinical trial design through
the Type C meeting process with the FDA. This meeting provides an opportunity for
formal written response to clarify and agree on the clinical trial design and other
supporting components for the IND submission and subsequent NDA submission, thus
providing clarification for the product registration pathway in the US.
• Paradigm’s Type C briefing book will be submitted, to the US FDA, in the coming weeks
and will include the phase 3 protocol as agreed upon with the EMA.