Paradigm Biopharmaceuticals’ Phase 2 clinical trial is a success…so far

Nick Sundich, October 4, 2022

One of the best pieces of news shareholders in a biotech stock can receive is successful Phase II clinical trial results and Paradigm Biopharmaceuticals (ASX: PAR) has delivered that this morning. Shareholders appear to have embraced the results, although they are only interim and there is some way to go before Paradigm Biopharmaceuticals gets regulatory approval for its drug.

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Another small step for Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals was founded to repurpose pentosan polysulphate sodium, or PPS for short. It eventually settled on osteoartritis (OA), hoping that injecting PPS could reduce the pain. And OA is a big market with over 300m global cases in knee and hip OA alone.

Today’s study was not the first set of positive data and only interim – the study will go for 12 months but the data was from Day 56. Nevertheless, it was positive news.

PPS treatment showed statistically significant improvements in pain, function, stiffness and WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) scores. 73% achieved a reduction in pain of 30% or greater while 60% achieved an improvement of 50% of greater.

More important milestones coming

But Paradigm Biopharmaceuticals has bigger ambitions. It is going for FDA approval for OA and is undertaking two Phase III clinical programs with that end goal in mind.

Approval is ultimately up to the FDA and only stands a chance if the results pass Phase III. But the fact that PPS has passed multiple earlier studies and obtained FDA Fast Track Approval helps its cause.