Paradigm Biopharmaceuticals Ltd (ASX:PAR) has now dosed the first participant in the Phase 2b clinical trial at Emeritus Research in Malvern East, Victoria.
The research is undertaking a randomised, double-blind, placebo-controlled Phase 2b clinical trial investigating the drug pentosan polysulfate sodium (PPS) vs placebo in people with knee osteoarthritis and concurrent bone marrow lesions.
One hundred participants will be recruited across five trial sites in Queensland, South Australia, Victoria, and Western Australia with results anticipated in the March quarter of 2019.
The importance of the trials
Osteoarthritis is a condition with a significant unmet medical need.
An injectable PPS has the potential to be a break-through in treatment, as current therapies do not have adequate pain-relieving effects and provide no protection for the degenerating joint structures.
There are also significant adverse side effects.
A recent licensing deal highlights significant potential commercial opportunity for PPS, as French pharmaceutical group, Servier, licensed a Phase 1 OA drug candidate for US$346 million for rights to the European region.
Paul Rennie, chief executive officer, commented:
"We are very pleased to confirm the first participant has been treated in this important clinical trial.
"Injectable PPS could be a promising, safe and effective treatment for OA with concurrent BMLs – a condition with significant unmet medical need.
"Moreover, the Servier deal for GLPG1972, a Phase 1 drug that only inhibits ADAMTS-5, illustrates the potentially significant commercial value of PPS as PPS inhibits both cartilage destroying enzymes ADAMTS-4 and ADAMTS-5."