The clinical trial subjects receiving Paradigm’s injectable pentosan polysulfate sodium (iPPS) were shown to have:
• improved knee function for 6 months;
• durable pain reduction for 6 months, and
• reduced bone marrow lesion (BML) grade, volume and area at day 53.
Importantly, the reduction of BML signals the possible regression of the disease.
BML before and after the treatment
Paradigm has now successfully met both the primary endpoint and secondary endpoints of its phase 2b trial in OA of the knee.
Paradigm CEO Paul Rennie said: “We are pleased with the positive Activities of Daily Living data and the positive objective MRI data being reported today.
“Additionally, the KOOS pain reduction to day 165 demonstrates the potential of iPPS to be a long-lasting and efficacious pain treatment in subjects with OA.
“Traditionally, in OA sufferers, bone marrow lesions remain the same size or get larger over time.
“Here, we see iPPS producing a net 65% reduction in BML Volume in the NRS 4-6 strata, which is impressive, especially considering the MRI images were taken just two weeks after the last injection of iPPS, which is a very short time period after cessation of the drug.
“At such an early time-point of Day 53 we were looking for early MRI signals to demonstrate the trend in remission of BMLs.
“To have such a magnitude of difference on the total knee volume and area and statistically significant difference for the medial compartment of the knee is an amazing result and something that the medical, scientific and pharmaceutical fraternity will appreciate the importance of.”
Treating OA without an opioid
OA remains the most common form of joint disease globally. In the US alone, it affects over 30 million adults, while in Australia, arthritis affects around 3 million people.
The demand for a new effective treatment is significantly amplified by the opioid epidemic throughout the US.
Paradigm’s iPPS is neither an opioid nor a steroid and most importantly is non-addictive, thus has the potential to positively impact the opioid epidemic and treat OA pain.
Paradigm believes iPPS has the potential to receive Fast Track designation from the US Food and Drug Administration (FDA), which is greatly concerned about the opioid epidemic.