Biotech company Paradigm Biopharmaceuticals (ASX: PAR) continues to make progress on its mission of developing a radical shift in reducing chronic joint pain from osteoarthritis.
With results from its ongoing clinical trial trickling in, the interim results are adding further impetus to the company’s share price, with shares now trading at $0.89 per share – up around 200% in the last 6 months.
Paradigm received a further sentiment boost this morning with the news that its pain reduction rate has again been corroborated by an additional 25 patients with osteoarthritis, treated with injectable Pentosan Polysulfate Sodium (iPPS) – the company’s flagship treatment currently being progressed under a Special Access Scheme (SAS) conducted by the Therapeutic Goods Administration (TGA).
Results from its latest batch of 25 patients now put the company’s average at 51.5% thereby indicating that its iPPS treatment can be used to treat joint pain, including for top-tier athletes.
Comparing pain reduction
As a like-for-like comparison, Paradigm says that the pain-reducing effects of iPPS are considered “significantly superior” than the typical 15% pain reduction scores reported for opioid treatments for chronic pain in knee osteoarthritis of the knee and hip.
The comparative advantage, therefore, raises the likelihood that once Paradigm negotiates its way through its current set of clinical trials, it could end up commercialising the most effective pain reduction treatment currently available anywhere in the world.
As it stands, iPPS is only available via the TGA’s scheme and is not currently registered in Australia as an available treatment. However, iPPS is registered in four of the seven major global pharmaceutical markets including Europe, where the treatment has been designated as an “antithrombotic agent”.
Within the retail market, more than 30 million adults are afflicted with osteoarthritis in the US and around 3 million in Australia. The high prevalence and growing rates of osteoarthritis, therefore, represent a strong commercial opportunity for any company that can successfully develop and market an effective pain reduction treatment.
Paradigm is on track to prove the effectiveness of its PPS treatment by conducting a phase 2b clinical trial and administering it under the TGA’s scheme. Paradigm has forecast that its trial is expected to be completed by the end of 2018 with more than 200 patients expected to be included in the results.
Furthermore, results obtained from the 125 patients Paradigm has recruited so far, precede the read-out from Paradigm’s 110 participant phase 2b randomised, double-blind, placebo-controlled, multicentre, clinical trial.
With results coming in thick and fast, Paradigm has said that it envisages there could eventually be more than 150 patients that are included in the trial before the Phase 2b clinical trial results are published.
“The total figure is difficult to estimate due to the ever-increasing patient demand to be treated via the TGA Special Access Scheme,” the company said.
The additional results published today are therefore highly significant, as they provide important real-world evidence (RWE) data, which can be used in combination with randomised controlled clinical trials to support product registration for repurposed pharmaceuticals under the FDA’s 505(b)(2) regulatory pathway in the US – a key future target market.
Potentially even more significant is Paradigm’s consistently high pain reduction rate in excess of 50% which means its iPPS therapy is on course to be proven as “clinically meaningful” – a term used to describe chronic pain reduction in the order of 25-30% or more.
“We are very pleased to see that since October 2017 and after the report of the fifth group of real-world evidence patients there is a consistent average knee pain reduction of greater than 50% in the 125 patients,” said Mr Paul Rennie, CEO of Paradigm Biopharmaceuticals.
Mr Rennie added that “we feel particularly confident regarding a positive clinical trial outcome, with the expected release of headline results for that trial due at the end of Q4 CY2018.”