Paradigm Biopharmaceuticals Ltd.'s injectable drug was shown to be safe for treating joint pain caused by a certain viral infection, achieving its main goal in a mid-stage study.
The phase 2a study evaluated injectable pentosan polysulfate sodium, or iPPS, in patients with chronic Ross River virus induced arthralgia, or joint pain. Ross river virus is a mosquito-borne virus which causes fever, rash and joint pains. There is currently no treatment that is effective in shortening the duration or changing the course of the viral infection.
The study also demonstrated that iPPS reduced RRV disease symptoms over time compared to placebo, a secondary goal of the clinical trial.
Patients who participated in the study were diagnosed through laboratory tests and their conditions progressed from the acute phase with sustained chronic symptoms between three and 12 months after the infection. When the chronic stage starts, patients experience debilitating musculoskeletal pain for which there is no adequate or standard treatment, Paradigm added.
Twenty patients were recruited for this study; 18 completed the treatment.
Eleven received iPPS, and seven were on a placebo. Paradigm said there were no clinically significant differences in the safety of the iPPS and placebo groups.
The Melbourne, Australia-based drugmaker also highlighted improvements in patients' quality of life, along with reduced joint symptoms and strengthening hand grip after being treated with iPPS over a period of time.
Paradigm plans to use the study's results to support commercial discussions with the U.S. Department of Defense.