Paradigm is working to advance osteoarthritis treatment. Pic Getty Images.
Health & Biotech
Special Report: Frequently referred to degenerative joint disease or ‘wear and tear’ arthritis, osteoarthritis is the most common form of the condition. One ASX company is looking to diminish its impact by maintaining sufferers’ functional mobility and reducing pain.
Paradigm Biopharmaceuticals (ASX:PAR) is primarily focused on development of injectable pentosan polysulfate sodium (iPPS/Zilosul) for treatment of diseases such as osteoarthritis (OA) and Mucopolysaccharidosis (MPS) where inflammation plays a major pathogenic role.
Founded in 2014 and listing on the ASX in 2015, PAR recently unveiled positive new analysis from its phase 2 clinical trial of iPPS for treatment of OA in the knee, treating both symptoms along with preserving and/or regenerating joint tissues.
A single 6-week treatment course of (iPPS), which is demonstrating both anti-inflammatory and tissue regenerative properties, showed pain reduction and functional improvement effects through the 12-month study. Notably there was an increase of cartilage thickness from baseline as shown by MRI imaging at six months.
The phase 2 clinical trial was performed concurrently with Paradigm’s ongoing phase 3 study.
In short, PAR’s phase 2 results establish that a short course of iPPS showed positive structural changes in the affected knee joint and offered clear signs of how OA can be effectively treated.
No OA drug has previously shown durable and meaningful improvements in pain and function at 12 months after a single course of treatment.
In 2022, the global market for osteoarthritis therapeutics was valued at $8.28 billion, and it is anticipated to reach approximately $20.24 billion by 2032.
PAR managing director Paul Rennie recognises just how large the opportunity is to provide an effective treatment for OA, which primarily appears in the hands, hips, knees, back and feet. There is a high unmet need for new safe and effective treatments for OA with the US FDA providing Fast Track designation to Paradigm’s Phase 3 OA program as a potential to address this unmet need for knee OA.
OA involves progressive breakdown of the protective cartilage within a joint, resulting in changes to the underlying bone.
In knees, for example, studies show cartilage loss to be predictive of knee replacement surgery. If this cartilage is preserved, a patient may be able to delay or avoid going under the surgeon’s knife.
“The PAR phase 2 trial results establish that a short course of iPPS showed positive structural changes in the affected knee joint and offered clear signs of how OA can be effectively treated,” Rennie says.
“In the placebo group who didn’t get the active drug their cartilage was going down by 20 microns over the six-month period. Conversely, those who did get the drug saw their cartilage thicken by up to 60 microns.
“It is good news for people who suffer from osteoarthritis, good news for doctors treating osteoarthritis and shareholders looking for a high growth stock.”
Rennie says the amount of cartilage regeneration is ground-breaking in the field of OA treatment.
PAR has identified the optimal dose of 2mg/kg administered twice weekly for achieving durable responses in pain, function, and patient global impression of change (PGIC).
The company has now decided to incorporate the 2 mg/kg twice weekly regimen into their OA development program.
“Paradigm’s iPPS has demonstrated that it is improving the underlying disease as early as 6 months following a single 6- week treatment course,” he says.
“Added to that we’ve seen very significant down regulation of disease biomarkers at six months in the synovial fluid, which is the fluid inside the knee joint.
“Thirdly, we’ve also seen significant clinical improvement including reduction in pain and improvement in joint function out to 12 months. No other treatment for OA is showing these improvements together from one course of treatment.”
PAR received strong support a $30m capital raise comprising an $18m institutional placement, and a $12m 1-for-10 entitlement offer.
Fully underwritten by lead manager Bell Potter Securities, raised funds will be used to fund its activities through to mid CY25, including completion of the top-line readout from its Pivotal Phase 3 OA clinical trial. Paradigm’s phase 3 Pivotal knee OA study has completed the first of 2 stages recruiting over 600 people from 7 countries globally.
Rennie say key upcoming catalysts for PAR include start of the next stage of its Phase 3 OA program, TGA provisional approval, readout of topline data for Phase 2 program for MPS and potential regional licensing agreements for OA and MPS.
The company is preparing to present the Phase 2 data package to global regulatory agencies including the TGA and US FDA.
“We’re certainly at an exciting stage for the company with clinical trials, regulatory advances and potential licensing deals,” Rennie says.
This article was developed in collaboration with Paradigm Biopharmaceuticals, Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
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