Paradigm Biopharmaceuticals (ASX: PAR) has taken a major step forward in its mission to develop new treatments for osteoarthritis, securing centralised Human Research Ethics Committee (HREC) approval for its pivotal PARA_OA_012 Phase 3 trial in Australia. This approval clears the way for trial site activations, with recruitment activities set to commence soon and first participant dosing expected in Q2 2025.
Streamlining the Path to Innovation
The centralised ethics approval simplifies the approval process across all participating sites, ensuring a faster, more efficient trial setup. The first trial sites are set to launch in Victoria, with up to 10 sites across Australia planned.
Paradigm’s Managing Director, Paul Rennie, emphasised the significance of this milestone:
“The ethics submission and subsequent approval by HREC for the PARA_OA_012 trial represents a critical milestone in our journey to bring iPPS to patients suffering from osteoarthritis. With our Australian sites ready to activate, we remain focused on our goal of enrolling and dosing the first subject in Q2 and advancing this transformative therapy through Phase 3 development.”
Trial Overview: Advancing Knee Osteoarthritis Treatment
The PARA_OA_012 trial is designed to evaluate the safety and efficacy of injectable pentosan polysulphate sodium (iPPS) as a treatment for knee osteoarthritis. The randomised, double-blind, placebo-controlled study will enrol approximately 466 participants across Australia and the United States. The primary goal is to assess pain reduction and functional improvement using validated clinical measures.
This pivotal trial builds on the promising results of the PARA_OA_008 study, which demonstrated significant pain relief and improved joint function for up to 12 months in patients treated with iPPS.
Next Steps: Site Activation and Patient Recruitment
With Advanced Clinical appointed as the Clinical Research Organisation for the study, site preparations are now in full swing. Recruitment is on track for Q1 2025, with patient enrolment and first dosing expected to begin in Q2 2025.
Paradigm’s continued progress highlights its commitment to addressing the unmet medical needs of osteoarthritis patients, bringing potentially game-changing treatment options closer to reality.
