Total
0
Shares
Paradigm Biopharmaceuticals (ASX:PAR) - Interim Chairman, Paul Rennie - The Market Herald
Interim Chairman, Paul Rennie
Source: Paradigm Biopharmaceuticals
Market Herald logo

Subscribe

Be the first with the news that moves the market
  • The US FDA requests further clarification from Paradigm Biopharmaceuticals (PAR) for its Investigational New Drug (IND) application
  • PAR lodged the IND application to the FDA in March, marking the first major submission for the study of its Zilosul drug in treating knee osteoarthritis
  • Now, the FDA has accepted five of six questions completed by PAR, and is requesting clarification around recently completed non-clinical toxicology studies
  • Despite delays to the process, PAR says it's confident it can address the FDA's one remaining question
  • Shares dropped 11.5 per cent to trade at $1.97 at 10:20am AEST

The US Food and Drug Administration has requested further clarification from Paradigm Biopharmaceuticals (PAR) for its Investigational New Drug (IND) application.

PAR lodged the IND application to the FDA in March marking the first major submission for the study of its Zilosul drug in treating knee osteoarthritis.

While the company had already responded to several questions from the FDA on the 30,000-page submission, in April, the FDA requested additional time to review the application and put forward more questions.

In May, the FDA issued written feedback on the submission, requesting answers to six further questions.

Now, following a 30-day review period, the FDA has accepted PAR's responses to five of the six questions and is requesting further clarification on one remaining question.

Par said the question is directed at the non-clinical interpretation and clinical mitigation relating to recently completed good laboratory practice (GLP) 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 pentosan polysulfate sodium.

Of those studies conducted, the FDA is seeking clarification on one rat GLP study.

To move forward with the process, PAR said it will now complete the response with the assistance of expert clinical and non-clinical consultants.

The company's response will include clarification on the non-clinical question and mitigation plan in the protocol.

Paradigm Chief Medical Officer Donna Skerrett said that such a thorough assessment process is normal.

"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."

Despite the delays, in conjunction with COVID-19 resulting in all communications being written and further slowing the process, Donna said the company is confident it 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."

Shares dropped 11.5 per cent to trade at $1.97 at 10:20am AEST.

More From The Market Herald
ImpediMed (ASX:IPD) - MD and CEO, Richard Carreon - The Market Herald

" ImpediMed (ASX:IPD) initiates SOZO heart failure program

ImpediMed (IPD) has initiated its SOZO heart failure program at Advocate Health Care’s Heart Institute in Chicago.    
Invex Therapeutics (ASX:IXC) - Chairman, Jason Loveridge - The Market Herald

" Invex Therapeutics (ASX:IXC) pens agreement for commercialisation of Presedin

Invex Therapeutics (IXC) has signed an agreement for the commercialisation of its treatment for neurological conditions caused by intracranial pressure.
LBT Innovations (ASX:LBT) - CEO and MD, Brent Barnes - The Market Herald

" LBT Innovations (ASX:LBT) subsidiary appoints US distributor

LBT Innovations (LBT) 50 per cent owned joint venture company, Clever Culture System (CCS), has appointed Thermo Fisher Scientific as its US distributor.
Paradigm Biopharmaceuticals (ASX:PAR) - Chief Medical Officer and Executive Director, Dr Donna Skerrett - The Market Herald

" Paradigm Biopharma (ASX:PAR) receives FDA feedback for knee osteoarthritis drug

Paradigm Biopharmaceuticals (PAR) has received feedback from US Food and Drug Administration (FDA) for its knee osteoarthritis drug.