Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received positive feedback from a European Medicines Agency (EMA) scientific advice meeting which provides a clear path forward to registration for Zilosul® in Europe.
Paradigm submitted its Scientific Advice briefing pack for the lead indication, knee osteoarthritis (OA) in May 2020, with the virtual meeting taking place between Paradigm and EMA representatives on September 1.
This regulatory engagement with the EMA covered key elements of Phase 3 clinical studies and associated pre-clinical and manufacturing processes for Zilosul® that will support the submission of a Marketing Authorisation Application (MAA) in Europe for the targeted knee osteoarthritis indication.
The EMA agreed on key aspects of the proposed adaptive clinical trial design, including the conduct of two global, multicentre and randomised studies that will assess pain reduction from baseline and improved function in OA patients.
“Clear direction to advance registration”
Paradigm chief medical officer Dr Donna Skerrett said: “Paradigm is very pleased with the valuable guidance received from the EMA which provides clear direction as we advance our Phase 3 registration program toward bringing Zilosul® to market.
“The company remains focused on further demonstrating, via our Phase 3 clinical trials, the potential for Zilosul to be a treatment for the huge population of people suffering with chronic knee pain as a result of OA.
“This is another step toward our aim to have the pivotal protocol acceptable in all major jurisdictions providing Paradigm with a clarified path to global approval of Zilosul® should our clinical trials be successful.
“We look forward to updating the market on the FDA Type C meeting progress in the coming weeks.”
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Commencing clinical trials in Europe
Paradigm now has an agreed-upon regulatory path forward for the development of Zilosul® for the treatment of OA based on detailed review, discussion and written feedback from the EMA concerning the product characterisation, nonclinical, phase 2 clinical data and phase 3 clinical trial designs.
Based on this feedback, applications to commence clinical trials in EU member countries can now begin.
Paradigm intends to submit the same phase 3 clinical trial protocol to the US FDA in its upcoming Type C briefing book in order to receive similar detailed feedback on the sufficiency of the planned phase 3 trials and supporting documents for the regulatory pathway in the US.
US registration pathway
Paradigm is 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 - 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.