US FDA Grants Fast Track Designation for Paradigm’s Phase 3 Osteoarthritis Program

US FDA Grants Fast Track Designation for Paradigm’s Phase 3 Osteoarthritis Program

• FDA Fast Track Designation for Pentosan Polysulfate Sodium (Zilosul™/PPS) offers pathways to expedite development of Paradigm’s osteoarthritis clinical
• FDA Fast Track acknowledges osteoarthritis as a serious disease with unmet need and the potential for PPS to offer a treatment for OA.
• Fast Track designation allows Paradigm the opportunity to interact and collaborate with FDA more frequently during program This enables a stronger overall program in line with the FDA’s expectations and provides opportunity for shorter review timelines.
• In February, Paradigm submitted a request for Fast Track Designation, which has now been approved, following the 60-day FDA review process.

MELBOURNE, AUSTRALIA – 12 April 2022 - Paradigm Biopharmaceuticals Ltd (ASX: PAR) (“Paradigm” or “the Company”), a clinical stage biopharmaceutical company focussed on repurposing existing molecules for new indications with unmet clinical needs, is pleased to announce 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 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.

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.”

Full ASX announcement here

About Paradigm Biopharmaceuticals

Paradigm Biopharmaceuticals LTD (ASX: PAR) is a late-stage drug development company with the mission to develop and commercialise Pentosan Polysulfate Sodium for the treatment of pain associated with musculoskeletal disorders driven by injury, inflammation, aging, degenerative disease, infection or genetic predisposition.

To learn more please visit: www.paradigmbiopharma.com

About Osteoarthritis

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 OA.¹ 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.

References:

1. Global Health Data Exchange, Institute for Health and Metrics Evaluation, University of Accessed June 2021 http://ghdx.healthdata.org/gbd-results-tool

2. Osteoarthritis: A Serious Disease, Submitted to the U.S. Food and Drug Administration December 1, 2016

About the Phase 3 Trial (PARA_OA_002)

The purpose of the trial is to measure the change in pain and function after subcutaneous injections of PPS compared with subcutaneous injections of placebo in participants with knee OA pain. This is a 2-stage, adaptive, randomised, double-blind, placebo-controlled, multicentre (US/AUS/UK/EU) study that will evaluate the dose and treatment effect of PPS in participants with pain associated with knee OA.

The primary endpoint in the trial will be change from baseline at Day 56 in WOMAC® pain score, with secondary outcomes to include change from baseline at multiple time points out to day 168 in WOMAC® Pain and Function, Patient Global Impression of Change (PGIC) and Quality of Life (QoL).

The global PARA_OA_002 phase 3 clinical trial is currently screening and enrolling participants in both Australia and the US, with sites in Europe, UK, and Canada to be initiated.

Additional information on all of Paradigm’s programs and clinical trials can be found at ClinicalTrials.gov (002 - NCT04809376, 006 - NCT04814719) or via the Paradigm website www.paradigmbiopharma.com