Late-stage drug development company Paradigm Biopharmaceuticals (ASX:PAR) has confirmed the filing of the updated protocol for its Phase 3 clinical trial with the US FDA.
The 30-calendar day review period will officially begin on October 29th, upon receipt of the submission by the FDA. During this period, if the Agency does not request further information or raise additional questions, the review will conclude at the end of these 30 days.
Paradigm anticipates this review to be completed within this timeframe, allowing pre- screening and enrolment for the PARA_OA_012 trial to commence shortly afterward. Preparations are already underway at trial sites across Australia and the United States, with initial activities to be launched at up to 10 sites in Australia, targeting first patient enrolment by Q1 CY2025.
Following FDA clearance to proceed with the Phase 3 PARA_OA_012 clinical trial, Paradigm expects to provide additional updates regarding trial design, clinical trial funding and ongoing commercial discussions. The Company is committed to keeping investors informed throughout this critical stage of the clinical programme.
“The submission and acceptance of our Phase 3 protocol by the US FDA is a critical milestone for Paradigm, bringing us one step closer to delivering a meaningful treatment for knee osteoarthritis,” Managing Director, Paul Rennie, said.
“We are optimistic for a smooth 30-day review period with the agency and extend our gratitude to the FDA for their valuable input throughout the Type D meeting process.”
Now Paradigm has made the submission of its documents to the FDA, there are two possible outcomes (i) the FDA review the protocol and have no further comments within the initial 30-day review period, which means Paradigm can commence with the Phase 3 clinical trial or (ii) the FDA has further questions within the initial 30-day review period and if so another 30 day review period will commence from the date of the Paradigm’s submitted response.
“The submission of the protocol along with all the associated updated clinical trial documents represents a significant achievement and reflects the hard work, persistence, dedication, and expertise of the entire Paradigm team, who have worked tirelessly to meet the stringent requirements of this programme,” Mr Rennie said.
“I want to commend and thank everyone involved for their commitment to advancing our mission and for positioning us for success as we move into this pivotal phase. At Paradigm, we all have a common goal to bring Zilosul to market, and today's news is a major step forward to achieving that goal.”
