Paradigm Biopharmaceuticals Ltd (ASX:PAR) has met with the US Food and Drug Administration (FDA) for a pre-investigational new drug (IND) meeting to discuss the development and market authorisation plans for its flagship drug Zilosul®.
Zilosil® is injectable Pentosan Polysulfate Sodium (iPPS) for the treatment of symptomatic osteoarthritis.
The FDA’s IND program is the means by which a pharmaceutical company gains permission for human clinical trials before a marketing application for the drug has been approved.
Paradigm chief executive officer Paul Rennie said: “The team and I are pleased with the positive feedback from the FDA at the Pre-IND meeting that took place yesterday.
“Paradigm looks forward to providing a more detailed update to the market once the final minutes of the meeting have been received.”
In the meeting Paradigm discussed its clinical, pre-clinical and CMC (manufacturing) data with the FDA.
Remains fully funded for Phase 3 clinical trial
Earlier this week Paradigm dosed the first patient under the US FDA approved Expanded Access Program (EAP) with Zilosul® and the company is proceeding towards an IND filing in the fourth quarter of 2020.
The company is progressing through regulatory processes in several regions including the US, Australia and Europe.
Paradigm confirmed it remains fully funded for its proposed Phase 3 Clinical Trial of the drug.