Paradigm Biopharmaceuticals Ltd (ASX:PAR) has received data from an additional 38 patients with knee OA that were treated with injectable pentosan polysulfate sodium (iPPS).
Combining today’s results of 38 patients with the previously reported 145 patients brings the on average reduction in pain scores to 51.4% across the 183 patients.
These results continue to be significantly superior to the typical 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip.
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Paradigm’s CEO Paul Rennie said: “We are very pleased to see that since October 2017 and after the report of the seventh group of Real World Evidence patients there is a consistent average knee pain reduction of greater than 50% in the 183 patients.
“Of important relevance to us is that Paradigm now has accumulated data on 183 patients being successfully treated with iPPS for OA associated BMELs.
“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.
“Given these patients have a very similar treatment regimen to subjects being treated under the current phase II OA randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat OA, we now look forward to the read-out of the Phase 2b randomised double-blind placebo multicentre clinical trial on or before 21 December 2018.”
No serious adverse events supports safety of treatment
Paradigm is pleased to report that of the 183 patients that have been treated and reported on there have been no serious adverse events.
This provides further validation of the well-established safety profile of iPPS.
It supports the changes that a similar safety profile will be displayed in the current phase IIb trial underway.
Having a very safe pharmaceutical treatment is paramount in modern-day drug development.