Paradigm Biopharmaceuticals Ltd (ASX:PAR) is making headway with its investigational new drug (IND) application for its proposed pivotal clinical trial treating subjects with Zilosul® for pain associated with knee osteoarthritis (OA).
The company submitted its 30,000-page IND application to the US FDA, on Friday, March 26, 2021, and has received several questions from the FDA during the current 30-day IND review period that were answered within 48 hours of receipt.
However, on Friday, April 23, Paradigm received a verbal indication that the FDA would be putting further questions to the company outside the 30-day IND review period.
FDA to review in 30 days
The FDA was unable to provide all questions within the initial IND review period and has advised it will submit them to Paradigm within the next 30 days.
Many of the questions are expected to be related to newly submitted non-clinical data (as part of the IND application).
The company is ready to review and answer questions when they are received and on receipt of Paradigm’s responses, the FDA will review within 30 days.
Paradigm is committed to keeping investors up to date with its development program and will update the timeline once clarity is received.
IND Submission
The submission includes reports on the phase 1 study in healthy volunteers completed in quarter four of 2020 as well as several non-clinical studies that detail the pharmacokinetics and toxicology of Pentosan Polysulfate Sodium (PPS).
It also describes the GMP manufacture of the active substance and the drug product used for the pivotal phase 3 studies.
Once the IND is 'Open' the company may begin recruitment and screening of participants for the study.
Site selection is close to being finalised in the US and Australia with 60 of a planned 65 sites already approved to participate in the clinical trial.