Paradigm Biopharmaceuticals (ASX:PAR) has received results from its phase 2a clinical trial in bone marrow lesions (bone bruising) as a result of an anterior cruciate ligament (ACL) injury.
Importantly, the primary endpoint of safety and tolerability was met.
Paradigm was also successful in meeting its secondary endpoint, demonstrating a statistically significant reduction in bone marrow lesion (BML) volume as measured by MRI.
The top line results come from the analysis of safety data on 11 people who participated in the phase 2a open label trial to evaluate the drug, pentosan polysulfate (PPS).
The trial success confirms the company’s hypothesis that PPS could be a new treatment for acute joint injuries.
Overall 6 of 9 (66.6%) participants showed reduction in BML and 8 of 9 (88.8%) had reduction in effusion-synovitis volume.
These results indicate that PPS has potential to significantly improve recovery from acute ACL injury, with significant improvement in both bone marrow lesion volumes and effusion volumes, function improvement and improved long-term outcomes for patients.
Paradigm’s patent to treat BMLs with PPS is already granted in the U.S, Japan and Australia.
The multi-billion dollar post-traumatic osteoarthritis (PTOA) market is very large with unmet medical needs.
Paul Rennie, CEO, commented
“The statistically significant reduction of both bone marrow lesion volume and effusion-synovitis volume is very encouraging data.
“Paradigm is delighted that the open labelled clinical trial (with blinded analysis of MRI’s before and after PPS treatment) successfully achieved its primary and secondary endpoints.
“We are also delighted to show for the first time both BML volume and effusion-synovitis volume was significantly reduced within a 2-month period postacute injury.
“We are hopeful the drug PPS could become standard of care, post-surgical reconstruction, with the potential to reduce the risk of a person developing PTOA”.
Other trials in process
In addition to the ACL clinical trial, Paradigm is also conducting two phase 2 clinical trials in degenerative osteoarthritis and viral induced arthritis.
The degenerative osteoarthritis is a phase 2b randomised, double-blind, placebo-controlled clinical trial with 100 patients.
The viral induced arthritis is a phase 2a randomised, double-blind, placebo-controlled clinical trial with 24 patients.
Paradigm expects to update the market on the recruitment status of these two trials in the coming weeks.