Biotechnology company Paradigm Biopharmaceuticals (ASX: PAR) has reasserted its previously published figures relating to pain reduction resulting from its flagship drug treatment Pentosan Polysulfate Sodium (iPPS).
Development of iPPS is currently making strong progress as part of clinical trials in Australia with its pain reduction rate remaining well above expectations and the existing industry benchmark.
Not only that, but it is continuing to gain plaudits among existing patients, including AFL teams that have subjected dozens of players to iPPS.
Paradigm has reported a “consistent” reduction of pain from an additional 38 patients with osteoarthritis, bringing the overall total number of patients to 183 being successfully treated with iPPS for osteoarthritis-associated bone marrow edema lesions (BMEL).
The company has now accumulated data to satisfy the TGA-requested number of between 175 and 200 and thereby enabling the company to make assured conclusions regarding the drug’s efficacy.
Sequential pain reduction results
Paradigm is currently making progress with respect to iPPS by sequentially adding more patients to its ongoing study, with final results expected before the end of the year.
According to scientific consensus “clinically meaningful reduction” of chronic pain has been defined to be between 25-30% pain reduction – figures which iPPS has consistently superseded during its study.
“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”, said Paul Rennie, CEO of Paradigm Biopharmaceuticals.
Mr Rennie stated that the number of patients seeking treatment via the TGA’s special access scheme represents “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 2b osteoarthritis randomised, double-blind, placebo-controlled, clinical trial and these patients have failed current therapies to treat osteoarthritis, 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,” Mr Rennie said.
In the 183 patients treated, 88.5% responded with a reduction in joint pain and 91.2% of patients reported improvement in knee function.
From the self-reported pain scores, results show that pain reduction was recognised by 51.4% of patients and function was improved among 60.8% (on average) from baseline pain scores in 183 patients with knee osteoarthritis (OA) and concurrent BMEL.
Furthermore, from the 183 patients that were treated, “there have been no serious adverse events”, according to Paradigm.
The latest results validate the well-established safety profile of iPPS, reassuring the company that a similar safety profile is likely to be displayed in the current Phase 2b trial.
The positive results being reported by Paradigm means that the company could potentially deploy its iPPS drug on a much larger scale given that it “demonstrates superiority over the 15% pain reduction scores reported for opioid treatments for chronic pain in OA of the knee and hip,” the company said.
The comparative effects of iPPS therapy against existing opioid treatments implies that the patient-reported data have provided evidence of clinically meaningful improvements in chronic pain.
Following the raft of patient-reported outcomes, Paradigm is now looking forward to publishing its final read-out from its 110-patient Phase 2b clinical trial, expected by the end of this year.