FDA requests further clarification from Paradigm Biopharmaceuticals (ASX:PAR)

• 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.