SYDNEY: Paradigm Biopharmaceuticals Ltd (ASX: PAR), a clinical stage biopharmaceutical company focussed on repurposing existing molecules for new indications with unmet clinical needs, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the company’s phase 3 program investigating Pentosan Polysulfate Sodium (PPS) for the treatment of osteoarthritis (OA).
The FDA Fast Track program offers a number of benefits to help advance development and expedite the review of novel therapies for serious conditions for which there is an unmet medical need, with the aim of getting important new therapies to patients more quickly.
This Fast Track Designation from the FDA acknowledges that osteoarthritis (OA) can be a serious disease with an unmet medical need and that preliminary data demonstrate that Zilosul has the potential to address this unmet need.
Features of Fast Track Designation
1. Actions to Expedite Development and NDA Review
a. Opportunity to interact and collaborate with FDA more frequently during program development, for example, to discuss study design, extent of safety data required to support approval, dose-response concerns, and use of biomarkers.
b. Other meetings may be scheduled as appropriate (e.g., to discuss potential for accelerated approval request, the structure and content of a New Drug Application (NDA), and other critical issues).
c. In addition, such a product could be eligible for priority review request at the time of NDA submission. Priority review reduces the review time from 10 months to 6 months.
2. Submission of Portions of an Application (Rolling Review).
a. the FDA may determine, after preliminary evaluation of clinical data submitted by Paradigm, that that completed sections of the NDA may be submitted for FDA review. This means Paradigm can submit modules of the registration dossier in a staggered manner as opposed to submitting the entire dossier upfront, allowing for a faster review process.
Dr Donna Skerrett, Paradigm Chief Medical Officer and Interim CEO commented: “This is welcome news from the US FDA as the company continues to gain momentum in site activation and participant screening across the 56 selected sites in the US. Given the need to improve therapeutic options for patients suffering from pain and loss of functionality associated with OA, we are excited to have this Fast Track Designation granted for Zilosul and the regulatory support it provides in expediting the phase 3 development program to advance this promising treatment to patients sooner.
Paradigm believes Zilosul would represent an important medical advance in the treatment of debilitating osteoarthritis pain for patients who do not experience adequate pain relief or cannot tolerate currently available pain medications.”
OA is a chronic degenerative disease characterised by a progressive loss of cartilage, leading to pain, loss of joint function and disability. It is the most prevalent form of joint disease, affecting up to 16% of the population in the developed world, with more than 72 million people in the US, EU5, Canada and Australia suffering from osteoarthritis (OA).
The prevalence of OA is increasing in line with the aging population and increasing rates of obesity. By 2030, the number of people suffering from OA in the US alone is predicted to increase by 86% to 67 million.2 If we assume a similar increase across the other markets listed above, even allowing for lower rates of obesity in non-US markets, it is estimated that more than 120 million people will be suffering from OA by 2030.