Paradigm Biopharma unveils phase 2a clinical trial success for ACL injuries

Paradigm Biopharmaceuticals (ASX: PAR) announced a successful phase 2a clinic trial for treating bone marrow lesions with its pentosan polysulfate sodium drug (PPS) with participants showing safety and tolerability to the drug, followed by a reduction in bone marrow lesions associated with anterior cruciate ligament injuries.

The study involved using PPS to treat 11 patients with anterior cruciate ligament injuries and bone marrow legions. Nine out of 11 people completed the trial because two participants withdrew due to unrelated personal reasons.

“Early results suggest that the therapeutic intervention in acute traumatic joint injuries such as anterior cruciate ligament ruptures may reduce bone marrow lesion volume and synovitis-effusion volume within the acute phase of the injury,” sports physician and clinical trial investigator Dr Ruben Branson said.

He added the company hoped this would in turn reduce the risk of post-traumatic osteoarthritis, but cautioned further larger scale trials were required to prove this.

Phase 2a involved giving two intramuscular injections twice a week for three weeks. The injections were tolerated with no adverse reactions reported or found during treatment and the eight-week follow up period.

Prior to the trial, MRIs were taken to measure the impact of PPS on the bone marrow lesions with results from an independent and “blinded” reviewer showing a reduction in bone marrow lesion volume after treatment.

Of the nine participants, six displayed a reduction in bone marrow lesions, while eight had decreased effusion-synovitis volume.

This compares to natural recovery which takes up to 24 months for bone marrow lesion volume to lessen.

According to Paradigm, the results indicate PPS can improve recovery from anterior cruciate ligament injuries and enhance long-term outcomes.

Paradigm’s chief scientific officer Dr Ravi Krishnan said to the company’s best knowledge, this was the first time a therapeutic agent has shown a statistically significant reduction in bone marrow lesion and effusion-synovitis volumes within two months of surgical reconstruction.

“This clinical trial data provides support for further investigation of early pharmaceutical intervention of injectable PPS in the treatment of acute joint injuries to delay or halt the progression to post traumatic osteoarthritis.”

Mr Krishnan added a manuscript of the full study will be submitted for peer reviewing within the next 12 months.

Paradigm has patents for treating bone marrow lesions with its PPS in the US, Australia and Japan.

The company has cited research that shows post traumatic osteoarthrosis of the knee, hip and ankle comprises 5.6 million cases of the condition in the United States.

Paradigm claims the current financial burden for osteoarthritis sits at US$130 billion in the United States. Meanwhile, in Australia, arthritis costs the national health systems almost A$1 billion a year in 44,000 hip and knee replacements.

Last month, Paradigm reported a trial on osteoarthritis sufferers with PPS had resulted in an 83% decrease in pain. Phase 2 trials in degenerative osteoarthritis and viral induced arthritis are underway and Paradigm anticipates announcing updates in the coming weeks.