The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price has returned from its trading halt in style.
In morning trade, the drug development company's shares are up 19% to $1.50.
Why is the Paradigm share price rocketing higher?
Investors have been bidding the Paradigm share price higher today following the release of results from an osteoarthritis (OA) clinical study.
According to the release, the primary endpoint has been met for injectable PPS (iPPS) in the PARA_OA_008 phase 2 clinical trial.
The release explains that several OA biomarkers analysed were observed to favourably change over time in patients treated with iPPS compared to a placebo. Management notes that these biomarker changes provide insight into iPPS mechanisms of action as well as signals of disease modifying potential.
In addition, iPPS-treated subjects demonstrated statistically significant improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function, and stiffness scores at day 56 for the twice-weekly group compared to placebo.
This could be very good news for Paradigm as there is a significant market opportunity for an OA treatment. Management highlights that there were 303.1 million cases of hip and knee OA worldwide in 2017.
But it doesn't stop there. In a separate canine study, positive interim observations on the effects of iPPS treatment on dogs with naturally occurring OA were also reported. Seven of nine dogs treated with iPPS had a clinically meaningful functional improvement in the affected limb.
'Very encouraged'
Paradigm's chief medical officer, Dr Donna Skerrett, was pleased with the results. She said:
We are very encouraged by the synovial fluid biomarker signals we see in this study. The observed changes indicate mechanistic effects through pain, inflammation, and chondroprotective pathways. These changes are consistent with the clinical effects observed in this and prior studies of iPPS in osteoarthritis.
Evidence of multimodal effects supports our understanding of the actions of iPPS. These biomarker changes in the joint, following subcutaneous administration of iPPS, demonstrate local effects in the synovial fluid. These are meaningful signals that we will evaluate together with clinical and imaging outcomes in order to demonstrate disease modifying effects and to pursue regulatory authority guidance on a disease modifying pathway.
