FDA hands Paradigm Biopharma guidance to re-jig phase 3 osteo trial – or is it a delay?

Paradigm Biopharmaceuticals (ASX:PAR) has confirmed that it will use a twice weekly dosage of 2mg/kg injectable pentosan polysulfate sodium (iPPS) in its looming Phase 3 knee osteoarthritis trial in the US.

PAR lodged a ‘Type D meeting response‘ to the USA’s Food and Drug Administration (FDA) back in April of 2024; Wednesday’s news covers the agency’s response.

Without saying it, Paradigm has ultimately highlighted the FDA has asked it to re-jig some specifics around its Phase 3 osteo trial for patients affected by complications in the knee. At least one HotCopper user classified the announcement as pointing to a “delay.”

But Paradigm doesn’t see it that way – with much focus placed on the acceptance of the company’s proposed dosing regimen to be used in the Phase 3 trial – whenever that may be.

“This is a significant outcome for Paradigm, since based on the clinical data generated to date, with a dosing regimen of 2mg/kg iPPS administered twice weekly, the phase 3 clinical trial is best set up for success,” the company wrote on Wednesday.

According to Paradigm’s website: “Pentosan polysulfate sodium (PPS) is a semi-synthetic drug manufactured from the wood chips of European beech trees.”

In October 2023, the company declared results from an earlier-stage study found injections could help with preserving knee cartilage – or even reversing knee damage.

“I believe the clarity provided by the FDA’s response has brought us one step closer to entering the pivotal phase of the program,” Paradigm’s CMO Dr. Donna Skerrett said.

PAR last traded at 26cps.