Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received written feedback from the US Food and Drug Administration (FDA) on July 30, 2021 regarding Paradigm’s Investigational New Drug (IND) application submitted on March 26, 2021.
The company previously reported it had received written feedback from the US FDA, requesting answers to six questions relating to Paradigm’s IND submission.
Paradigm provided a response to the six questions raised by the FDA triggering another 30-day review period.
Response received from the US FDA
Paradigm received a written response from the FDA on 30th July, in which the agency accepted Paradigm’s responses to five of the six questions received.
The FDA response requires further clarification on one remaining question.
The question is directed at the non-clinical interpretation and clinical mitigation relating to one of Paradigm’s recently completed GLP (Good Laboratory Practices) non-clinical toxicology studies.
Paradigm conducted 26 non-clinical studies in 2020 at the request of the US FDA, to provide a GLP non-clinical portfolio of injectable PPS.
Of the 26 non-clinical studies conducted, the FDA is seeking clarification on only one rat GLP study.
Based on the response received from the agency, Paradigm will undertake the following:
1. Complete the response with the assistance of expert clinical and non-clinical consultants. The response will include clarification on the non-clinical question and mitigation plan in the protocol.
2. Continue its global phase 3 clinical trial start-up activities in Europe and Australia.
Paradigm anticipates submitting the requested information to the FDA within the month.
Confident of resolving one outstanding question
Paradigm chief medical officer Dr Donna Skerrett said: “For new indications that impact large populations, such as osteoarthritis, a thorough and iterative process with the FDA for initiating the pivotal registration studies is common practice.
“Even though the pace of progressing the clearance process has been slowed due to COVID-19 resulting in all communications being written, we are confident that we can address the FDA's one remaining question.
“We look forward to resolving the one outstanding question with the FDA and moving froward with our pivotal program in the US, Europe and Australia.”
Knee osteoarthritis clinical trial
Paradigm’s plans to open the pivotal Para_OA_002 OA clinical trial with PPS for the treatment of patients with knee osteoarthritis (OA) in Australia is continuing.
Eight sites have been selected and the protocol has ethics approval.
Paradigm is on schedule to commence screening participants in Australia during Q4 CY 2021 and site selection activities are currently underway in Europe.
Conference call for investors
Paradigm will be hosting a conference call for investors via the Lumi platform to discuss the response from the US FDA.
Current and potential investors will be able to participate online via https://web.lumiagm.com on smartphone, tablet or computer.
Meeting Details:
Event: Paradigm Biopharmaceuticals (PAR) Investor Call
Time: AUS: Tuesday 3rd August, 11:00am (AEST) US: Monday 2nd August, 9:00pm (Eastern)
Meeting Link: https://web.lumiagm.com/m#/300830238
Meeting ID: 300 830 238