Paradigm Biopharmaceuticals (ASX:PAR) is a late-stage drug development company working first and foremost to create a superior treatment for osteoarthritis.
In the background, Paradigm also has a rare disease clinal asset for Mucopolysaccharidosis (MPS) and early-stage data for acute respiratory distress syndrome, hayfever and heart failure.
But in the field of osteoarthritis, Paradigm Biopharmaceuticals has the scientific expertise – and hard data from existing and ongoing trial results – to know it could have just stumbled on a breakthrough drug to treat the disease.
We’ll get to Paradigm’s flagship drug shortly.
But given the month of May is actually arthritis awareness month – the disease has an advocational calendar date – perhaps it’s a fortuitous time to dive into osteoarthritis, a disease with no cure, to fully understand what Paradigm Biopharmaceuticals is offering.
What is arthritis?
When it comes to arthritis in general, the Arthritis Foundation predicts 1 in 4 (Americans) have been diagnosed with a form of arthritis, or similar conditions.
Osteoarthritis is just one kind of many different arthritic diseases, but we’re going to be focusing on it for this article, while Paradigm Biopharmaceuticals’ development team is focusing on it in the clinic.
To clarify, unlike rheumatoid arthritis, which is actually an autoimmune disease, osteoarthritis is a different disease which effectively ‘attacks’ cartilage, but does not weaponise the immune system.
“A destructive disease”
“First of all, osteoarthritis is not what a lot of people [think of it], as ‘wear and tear,’” Paradigm Biopharmaceuticals Managing Director Paul Rennie told HotCopper.
“Osteoarthritis is a destructive disease that increases its intensity over time, so people might start off … with an occasional sore joint, and over time, that pain starts to become chronic.
“We know from a lot of research that the major symptoms of the disease is chronic pain and also malfunctioning joints so … what we are embarking on is trying to address the unmet medical need.
For Rennie, it all comes down to one question:
“Can we find a drug that can address those symptoms, of pain and joint dysfunction and at the same time slow down the degradation of the tissue and preserve the joint longer than what it would ordinarily be preserved,” he concluded.
And Paradigm believes it’s found the drug it’s looking for.
And so what’s the drug?
Paradigm is seeking to treat osteoarthritis with Pentosan Polysulfate Sodium (PPS).
Trademarked ‘Zilosul,’ the compound has curious beginnings as far as pharmaceutical supply chains go: it’s extracted from the processed woodchips of European beech trees.
Polysulfate Sodium ultimately ends up mimicking glycosaminoglycans in the body, which form the basis of popular injection-based arthritis treatments.
Glycosaminoglycans are a type of carbohydrate which give the human body anti-inflammatory benefits, it can also assist with tissue repair.
But Paradigm chief Paul Rennie believes Pentosan Polysulfate Sodium could be an even better alternative – both for patients suffering with osteoarthritis, and, the company’s shareholders.
Already proven benefits
“So what we’re doing is working with a multimodal drug called pentosan polysulfate sodium, we know that the drug does produce very significant and symptomatic relief, and we’ve just finished a phase two trial,” Rennie explained.
“We showed that pain relief and joint function was improved out to 12 months after one course of the drug – the course of the drug is 12 injections over six weeks – and then [patients got] the symptomatic relief from that administration of the drug, for 12 months.”
That, in Paul Rennie’s eyes, is what makes PPS a “breakthrough” opportunity. He says there’s nothing like that, looking at current industry standards.
“We’re well on the way to developing a drug which can reduce those symptoms of pain and joint dysfunction, but with the additional benefit of preserving the joint so that people can then remain active and not have the problems associated with having a joint that’s completely destroyed,” Rennie said.
Perhaps also worth noting is that Pentosan Polysulfate (without the sodium) is a well-known existing drug to treat inflammation of the bladder walls, so some consumers at least are already aware of its anti-inflammatory properties as a substance.
Why should investors care?
Described as a “blockbuster opportunity,” it’s through a key relationship Paradigm is able to bring PPS forward in the market: Paradigm and a German company called bene pharmaChem are known to each other; the latter is the only PPS manufacturer approved by US regulator Food & Drug Administration – as in the big kahuna, the FDA.
“Through the extensive interaction and collaboration with bene pharmaChem and Paradigm’s European manufacturers of the injectable formulation of PPS (iPPS), Paradigm has been able to develop its clinical product for trials,” the company writes on its website.
In other words: Paradigm has an exclusive source for the stuff, and may be the only Australian company ready to leverage that supply chain, let alone the advantage it could offer the company in the US market.
But Paul Rennie, talking to HotCopper, left the most tantalising elements of PPS’s value proposition til last:
“We’re also very happy to report we showed in that phase two study we had a reduction in disease biomarkers, in other words, the people who received our drug had less breakdown of [joint] tissues than the people on placebo,” he explained.
“We also saw that there was an improvement in cartilage thickness in the people on our drug.”
The implications of that product being on the market are obvious.
What Paul Rennie wants investors to think about
“I think from an investor’s point of view … there’s a large market that can be addressed by this drug, and there is no drug currently on the market that can both reduce the symptoms and also reduce disease progression,” Rennie noted to HotCopper.
“We believe we are well on the on the way to producing an outcome that will be very beneficial for patients, and physicians, and that should then encourage investors to say ‘well, this has potential upside.’
Paradigm recently announced both Australian and US ethics approval for their Phase 3 trial, following FDA approval of the trial design. The company anticipated dosing first subjects for the Phase 3 trial, the final phase of development, in the coming months.
“Once the markets can see that we’re just getting to having the product approved, then the share price should appreciate significantly.”
Given what other biotech companies on the bourse down under have staged in the last twelve months, there’s good reason to think he’s right.
Join the discussion: See what’s trending right now on HotCopper, Australia’s largest stock forum, and be part of the conversations that move the markets.
Disclaimer: HotCopper had a commercial relationship with Paradigm at the time this article was crafted and published.