Paradigm Biopharma raises the stakes in osteoarthritis pain reduction

Paradigm Biopharmaceuticals ASX PAR osteoarthritis pain reduction knee Pentosan Polysulfate Sodium
With the combined results of 100 patients now treated, the average reduction in pain score is 52.9%.

Biotech company Paradigm Biopharmaceuticals (ASX: PAR) has announced further progress in its bid to develop a definitive pain reduction treatment for both elite athletes and sufferers of osteoarthritis.

Earlier today, Paradigm reported that it had achieved a 60% reduction in osteoarthritis pain as part of its ongoing TGA-approved special access scheme that has attracted several dozen AFL players and no less than 7 AFL teams.

Amongst the average public, more than 30 million adults are afflicted with osteoarthritis in the US and around 3 million in Australia – high prevalence and growing rates of osteoarthritis, therefore, represent a strong opportunity for 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 Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS).

The trial is expected to be completed by the end of 2018 with more than 200 patients potentially being included in the results.

The path to pain reduction

Paradigm has been adding patients to its study as part of a TGA special access scheme for over 2 years, gradually adding to its list of patients.

In its most recent results, Paradigm said that it had achieved a 60.5% reduction in pain from an additional 25 patients with osteoarthritis treated with injectable Pentosan Polysulfate Sodium (iPPS).

Furthermore, results from the additional 25 patients have improved the average pain reduction in the total 100 patients treated under the TGA SAS from 50.3% to 52.9%.

Injectable PPS is not currently registered in Australia but is however registered in four of the seven major global pharmaceutical markets.

In Europe, injectable PPS is registered as an antithrombotic agent while in Australia, injectable PPS for human use is not currently available for sale.

Also, the company confirmed that its strong results so far can be attributed to a vast proportion of the patients undergoing a six-week treatment period, which suggests “a greater response” compared to a three or four-week treatment period.

From its most recent 100 patients, Paradigm says 85% of the patients in the study responded with both a reduction in joint pain and an improvement in knee function.

The comparative effects of iPPS therapy against opioid treatments implies that the patient-reported data have “provided evidence of clinically meaningful improvements in chronic pain,” according to Paradigm.

The biotech company said that “clinically meaningful reduction of chronic pain has been defined to be between 25-30% pain reduction.”

Today’s results indicate that Paradigm remains on track to onboard around 150 patients and deliver its phase 2b clinical trial results later this year with “ever-increasing patient demand” for entry into the TGA special access scheme.

As the most common form of joint disease in the world, Paradigm estimates the treatment market for osteoarthritis is worth about US$5 billion per year.

If Paradigm manages to commercialise its PPS treatment, it could potentially scoop a sizeable portion of the market given the positive results recorded so far, including amongst high-profile athletes in the AFL.

“We are very pleased to see the fourth group of Real World Evidence patients report results that have outperformed the previous three groups of patients we treated under the program,” said Mr Paul Rennie, CEO of Paradigm Biopharmaceuticals.

“Of great importance to us is that Paradigm now has data on 100 patients being successfully treated with iPPS for OA associated BMELs. The number of patients seeking treatment via the TGA SAS is accelerating, which we believe is a strong indication that the patients are receiving a clinical benefit from the iPPS treatment.

“Furthermore, it is a significant positive outcome that all these patients have on average, a clinically meaningful reduction in pain greater than 50%. 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 OA, 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,” said Mr Rennie.

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