Paradigm Biopharmaceuticals Ltd (ASX:PAR) has secured regulatory and ethics approval to clinically trial its lead treatment candidate on osteoarthritis patients in the UK.
The green light represents the last in a series of approvals Paradigm needed to get the Phase 3 PARA_OA_002 trial off the ground.
Now, Paradigm is ready to commence clinical trial site activation in the UK and it expects to begin enrolling participants with knee osteoarthritis across five sites.
Shares in the healthcare stock were trading 6.36% higher at $1.287 each near market close after the news.
Milestone approval
In today’s market announcement, Paradigm’s chief medical officer and interim CEO Dr Donna Skerrett expressed her delight the program was getting off the ground.
“We are very pleased to have received the combined regulatory and ethics approval in the UK from the MHRA, which is another milestone, as we continue to progress with clinical site initiation of our phase 3 PARA_OA_002 study in Australia, the US and now in the UK,” she stated.
At the start of this year, the UK implemented a new system to review both regulatory and ethics applications that cover clinical trials of investigational medicinal products (CTIMPs).
The combined review offers the sponsor (Paradigm) a single application submission and co-ordinated review leading to a single UK decision for CTIMPs.
Before the new system, Paradigm was granted permission to become part of the pilot test phase rollout.
Now, as early adopters of the new process, Paradigm received additional support and direct communication from the UK regulators, a consolidated regulatory and ethics review, quicker review times, and reduced costs.
About Paradigm
Paradigm is on a mission to take existing, approved drugs and apply them in a new, patented application.
The healthcare stock’s primary focus to date is its pipeline indications covering the use of pharmaceutical compound Pentosan Polysulfate Sodium (PPS), supported by full patent and IP protection.
Commercially speaking, Paradigm is immediately invested in repurposing PPS to treat osteoarthritis.
There’s a global unmet need surrounding this ailment and Paradigm has advanced its treatment candidate to phase three clinical trials that address all aspects of the disease — including inflammation, pain and regeneration.
A key feature of PPS’ activity is its anti-inflammatory and tissue regenerative properties, and Paradigm’s wider focus remains exploring PPS' use in treating the myriad conditions that begin with and are sustained by inflammation.
Other indications include the treatment of joint function, mobility and pain in patients with mucopolysaccharidoses (MPS), chronic heart failure (CHF), treating alphavirus induced arthralgia (in patients with Ross River Virus and Chikungunya); and allergic respiratory conditions, including allergic rhinitis (AR) and chronic obstructive pulmonary disease (COPD).