- Paradigm Biopharmaceuticals (PAR) claims a trial of its injectable pentosan polysulfate sodium (iPPS) drug shows the treatment may slow disease progression in knee osteoarthritis (OA)
- The company has reported data from day 168 of its phase two trial, which it says demonstrates the disease-modifying OA drug (DMOAD) potential of iPPS
- The drug showed a 21 per cent improvement in mean cartilage loss score compared to a 4 per cent worsening in the placebo group, alongside a “statistically significant” reduction in bone marrow edema lesions
- PAR will now present data to the regulatory authorities to seek additional advice regarding the requirements for iPPS to obtain a DMOAD label
- PAR shares closed 6.27 per cent lower at $1.35 on Tuesday afternoon
Paradigm (PAR) has claimed a trial of its injectable pentosan polysulfate sodium (iPPS) drug showed the treatment may slow disease progression in knee osteoarthritis (OA).
The company has reported data from day 168 of its phase two trial, showing a 21 per cent improvement in the mean cartilage loss score for trial participants treated with iPPS compared to a 4 per cent worsening in the placebo group, as well as a “statistically significant” reduction in bone marrow edema lesions.
According to PAR, this demonstrated the disease-modifying OA drug (DMOAD) potential of iPPS.
The company said there was an urgent need for a DMOAD, as current treatments such as paracetamol, opioids, and nonsteroidal anti-inflammatory drugs (NSAIDs) were solely focused on symptom management rather than improvement.
“A non-opioid drug for treating the symptoms of osteoarthritis (pain and joint stiffness) with the durability of effect out to 168 days (6 months), plus signals of disease-modifying potential, is well poised to address a major unmet medical need,” PAR Managing Director and Chairman Paul Rennie said.
Data has confirmed a continuation of positive clinical outcomes from day 56 through to day 168 in response to changes and trends of four key biomarkers: ARGS, COMP, C2C, and CTX-II.
PAR also noted persistent and positive patient responses to Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, function and stiffness scores.
The company will now present the results of new MRI, molecular biomarkers and clinical outcomes to regulatory authorities to seek input and additional data requirements to obtain a DMOAD label.
PAR shares closed 6.27 per cent lower at $1.35 on Tuesday afternoon.