Paradigm leaps following favourable trial results

Having watched the share price tumble by around 30% since a $66m capital raise mid-August, shareholders in Paradigm Biopharmaceuticals (ASX: PAR) rejoiced in the 19% jump today following encouraging results for the drug developer’s clinical trial involving osteoarthritis patients.

Clinical trial results for treatment of diseases where inflammation plays a major role, released today coincided with the resumption of trade following a halt announced last Friday.

What captured the market’s attention this morning were revelations from the late-stage drug development company was a statistically significant improvement in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness scores at day 56 for the twice-weekly group compared to placebo.

In layman’s terms, several osteoarthritis (OA) biomarkers analysed were observed to favourably change over time in patients treated with iPPS compared to a placebo. 

Top-line results encouraging

Management notes the top-line results were encouraging at day 56, while further data is expected at 6 and 12 months.

CEO Marco Polizze believes that having achieved the primary endpoint with consistent significant reductions in pain in iPPS-treated patients - compared to placebo - is an outstanding milestone for the company.

“The biomarker changes following iPPS, the statistically significant signals that we are observing in the WOMAC scores along with the safety and tolerability of iPPS in this exploratory study, will be valuable in discussions with regulatory bodies (FDA and TGA) and commercial partners.”

To put the opportunity upside from OA treatment in context, management notes there were 303.1m cases of hip and knee OA worldwide in 2017.

Canine OA model

Meantime, within a separate canine study, positive interim observations on the effects of iPPS treatment on dogs with naturally occurring OA were also observed.

It’s understood seven of nine dogs treated with iPPS had a clinically meaningful functional improvement in the affected limb.

Paradigm Biopharmaceuticals is holding an investor webinar on 4th October 2022 to discuss the positive top-line results from the PARA_OA_008 phase 2 trial and early observations from the canine OA model.

Paradigm’s share price is down -26% over 12 months.

Consensus on Paradigm is Strong buy.

Based on Morningstar’s fair value of $2.03 the stock appears to be undervalued.

Paradigm Biopharmaceuticals share price snapshot.