Australia-based Paradigm Biopharmaceuticals has reported positive top-line results from a Phase IIa clinical trial of pentosan polysulfate (PPS ) conducted in patients with a ruptured anterior cruciate ligament (ACL ) injury and a bone marrow lesion (BML).
The open-label trial has met the primary endpoint of safety and tolerability with a statistically significant decrease in BML volume and effusion-synovitis.
Conducted in 11 patients, the trial assessed the safety, tolerability and efficacy of a course of six intramuscular PPS injections over a period of three weeks.
The trial recruited patients who developed bone marrow lesions following ACL injuries.
Nine out of the total participants are reported to have completed the trial without any serious adverse events, indicating the potential of PPS to significantly improve recovery from the injury.
Paradigm has also provided an update on two of its other Phase II trials of PPS being conducted for the treatment of arthritis.
A randomised, double-blind, placebo-controlled, multi-centre Phase IIb trial has completed 23% of patient enrolment from two sites and plans to initiate three additional sites from January next year.
With results expected in the fourth quarter of next year, the trial is seeking to investigate PPS in patients with knee osteoarthritis and concurrent subchondral bone marrow lesions.
Another Phase IIa trial is set to assess the safety, tolerability and effects of PPS in a total of 24 subjects with Ross River virus (RRV) induced arthralgia (painful joints) at four centres in Victoria and Queensland.
The trial has completed 60% of its enrolment and is scheduled to report results by mid-next year.