Paradigm Biopharmaceuticals Ltd.'s Zilusol helped reduce pain in patients with a type of knee arthritis in a mid-stage study.
Paradigm is evaluating its drug Zilusol, or injectable pentosan polysulfate sodium, against placebo in a phase 2b trial to treat 183 patients with knee osteoarthritis and subchondral bone marrow edema lesions.
Arthritis is an inflammation of one or more joints in the body causing pain. Osteoarthritis is the most common form of arthritis in the knee; the cartilage in the knee joint gradually wears away, resulting in bone rubbing on bone, which causes pain. Bone marrow edema is a condition that causes swelling, commonly in the hips and knees, when excess fluid in the bone marrow builds up due to an injury such as a broken bone or chronic conditions such as osteoporosis.
Paradigm said the trial met its main goal of reducing knee pain in line with the Knee Injury and Osteoarthritis Outcome Score, a common measurement to assess quality of life in patients with knee injury and osteoarthritis. The trial showed that 53 days after treatment began, 46.2% of patients who received the medicine showed a greater than 50% reduction in pain compared to 22.5% of patients receiving placebo.
The company said statistical differences were achieved for patients receiving Zilusol against those on placebo in the secondary goals of the trial, which were a reduction in pain intensity and a patient's belief about the efficacy of treatment. Paradigm said the drug was safe and no life-threatening adverse events were observed.
Paradigm will report complete results from the secondary goals in the first quarter of 2019, and plans to begin a phase 3 study of the drug in 2019. The company will also seek a fast-track designation with the U.S. Food and Drug Administration for the therapy.
The Australian biopharmaceutical company's stock was up by 13.26% to A$1.49 at market close on Dec. 18 on the Australian Securities Exchange.