New clinical trial data shows that its trial drug Zilosul (iPPS) also reduces knee cartilage degradation.
() has made a valuable discovery during its phase IIb osteoarthritis (OA) clinical trial.
Two biomarkers known as COMP and ADAMTS-5, which are found in patients with progressive OA, have been reducing upon treatment with Zilosul.
Zilosul is the name for Paradigm’s flagship trial drug, injectable pentosan polysulfate sulfate (iPPS)
Paradigm considers this a major new discovery which adds to the clinical evidence that Zilosul could materially impact the progression of a disease that previously was thought to have no effective disease modifying treatment options.
More data expected over coming months
Paradigm’s CEO Paul Rennie said: “We are very pleased to demonstrate that iPPS was able to reduce levels of the biochemical markers COMP and ADAMTS-5 which predict disease progression in OA.
“Of important relevance for Paradigm’s clinical development is that the biomarker results further validate the objective measures of the therapeutic effects of iPPS in association with the objective MRI reduction of subchondral BML and the clinically meaningful reduction of pain.
“Paradigm is expecting the release of more biomarker data in the coming months as the results are provided to the company by the reference laboratory."
Cartilage breakdown associated with OA & levels of COMP & ADAMTS-5
Summary of findings
Put simply, COMP & ADAMTS-5 are reliable indicators of progressively worsening OA, meaning, those patients with elevated levels of these biomarkers in their blood have experienced an increased level of cartilage degeneration.
As the cartilage around the joint breaks down, these biomarkers found in the joint cartilage are released into the blood. Cartilage degeneration is the hallmark outcome of patients with progressive OA.
The discovery by Paradigm, that patients treated with Zilosul saw a meaningful reduction in these biomarkers when compared to the placebo arm. This discovery appears to indicate that treatment with Zilosul protects, slows or stops the cartilage around the joint from degrading – slowing the progression of the disease.
Paradigm got more than they bargained for with clinical trial data
Rennie added “The most pleasing outcome of the phase IIb clinical trial was the positive correlation between the clinical outcomes and the objectively measured structural outcomes.
“The clinical outcomes saw the reduction in pain and improvement in joint functionANDadditionally the objective disease-modifying outcomes of reduced BML and reduction of cartilage degrading biomarkers.”
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