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Highlights:
- Paradigm Biopharmaceuticals (ASX:PAR) partners with Advanced Clinical for the PARA_OA_012 phase III osteoarthritis trial.
- Advanced Clinical brings a strong track record in clinical trials, patient engagement, and regulatory strategy.
- The trial is set to begin dosing participants in the second quarter of 2025.
Paradigm Biopharmaceuticals has selected Advanced Clinical as its preferred clinical research organization (CRO) for the PARA_OA_012 phase III trial. This partnership represents a significant step forward in the development of Paradigm’s knee osteoarthritis treatment, utilizing the repurposed anti-inflammatory drug pentosan polysulfate sodium (PPS), also known as Zilosul. After evaluating several global CROs, Paradigm decided on Advanced Clinical due to its strong expertise in clinical trial execution and a focus on patient engagement.
The partnership is expected to enhance the overall execution of the trial. Advanced Clinical's established experience in regulatory strategy and patient-centered approaches ensures a robust framework for managing this complex phase III trial. This strategic collaboration sets the foundation for the successful progression of the trial, which is expected to enroll nearly 466 participants.
Trial Design and Objectives
The phase III trial will assess the effects of iPPS, the active ingredient in Zilosul, on knee osteoarthritis. The trial aims to demonstrate improvements in pain relief and knee function through the administration of subcutaneous iPPS injections, compared to a placebo group. The trial is structured to span up to 64 weeks, with a primary endpoint focused on reducing knee pain as measured by a daily pain score. Additional secondary endpoints will evaluate knee function, stiffness, overall quality of life, and the use of rescue medications throughout the study period.
The study design incorporates findings from previous phase II trials, where iPPS was shown to have positive effects on knee osteoarthritis, both in terms of pain management and structural improvements. These effects, such as cartilage thickness and bone marrow lesions, will now be explored further in the phase III trial as secondary endpoints, building on the promising data from earlier research.
Regulatory Approvals and Study Preparations
The FDA has already approved the study protocol and dosage for the trial, allowing Paradigm to proceed with its preparations. These include activating clinical trial sites and initiating patient recruitment, with dosing expected to commence by the second quarter of 2025. Paradigm Biopharmaceuticals is advancing toward its clinical goals, focusing on optimizing patient outcomes through innovative approaches to osteoarthritis treatment.
A Commitment to Improving Patient Experiences
This collaboration with Advanced Clinical reflects Paradigm Biopharmaceuticals' commitment to improving the lives of individuals affected by osteoarthritis. The company continues to prioritize patient-centered approaches in its research and treatment strategies. With the support of a trusted CRO, Paradigm is poised to continue its efforts in advancing therapies that aim to address both the symptoms and structural causes of knee osteoarthritis.
