The total real-world patients treated with iPPS is now 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.
After recently raising $77.9 million, the company is well funded to deliver on a pipeline of potential catalysts in 2019.
Paradigm’s CEO Paul Rennie said: “We are very pleased to see that since October 2017 and after the report of the eighth group of SAS patients there is a consistent average knee pain reduction of greater than 50% across 205 patients.
“Of important relevance to us is that Paradigm now has accumulated data on 205 patients being successfully treated with iPPS for OA associated BMLs.
“The number of patients seeking treatment via the TGA SAS is a strong feedback that the patients are receiving a clinically meaningful benefit from the iPPS treatment.
“Our strategy of obtaining real world evidence as we prepare our FDA IND submission for our Phase 3 OA trial will provide valuable data on our newly manufactured Phase 3 trial product and will assist in fine tuning our Phase 3 Trial design.”
Phase 3 clinical trial product to also be used in real world
Notably, Paradigm has completed the production of its phase 3 clinical trial product
From the September quarter of this year, doctors will treat patients with the phase 3 clinical trial product under the TGA SAS.
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.