18 patients were dosed, 11 with injectable pentosan polysulfate sodium (iPPS) and 7 with placebos.
Importantly, the primary endpoint of safety was met and encouragingly results demonstrated iPPS reduced RRV disease symptoms compared to the placebo.
For example, at the 3-month follow-up, 72.7% or 8 of the 11 subjects in the iPPS group showed near remission of symptoms based on Rapid-3 disease assessment in contrast to 14.3% or 1 of the 7 in the placebo group.
RAPID-3 scores are correlated with clinical disease activity and enable the quantitative monitoring and documenting of improvement or worsening over time.
A reduction in Rapid 3 signifies improvement in clinical disease activity.
Successful results to progress commercial discussions
Paradigm’s CEO Paul Rennie said: “We are very pleased to see that this small pilot RRV study has yielded very promising safety data and key efficacy outcomes in the reduction of disease symptoms in this debilitating chronic phase of the disease.
“The human data on the effects of iPPS in RRV induced arthralgia together with our preclinical work on CHIK-V will progress our commercial discussions with US Department of Defense.”
Recently, Paradigm also received real-world data from 22 more patients with knee osteoarthritis (OA) treated with iPPS.
This increased the total real-world patients treated with iPPS to 205 with a recorded 51.3% reduction in pain.
The 51.3% average reduction in pain score across 205 subjects with knee OA, continues to demonstrate iPPS’s superiority over the 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.
Paradigm is aiming to achieve Fast-Track designation and begin a phase 3 trial in the US in CY2019, both these initiatives are expected to attract significant big pharma interest.