VICTORIA, BC – Eupraxia, an emerging pharmaceutical company focused on optimizing drug delivery, announced today the initiation of STEP UP – a phase I study of its lead investigational product (EP-104IAR), for the treatment of pain associated with osteoarthritis (OA) of the knee.
EP-104IAR is an extended release formulation of the commonly used corticosteroid fluticasone propionate that is delivered by intra-articular injection into the knee. Eupraxia’s patented technology coats the drug particle with a biocompatible polymer that has been shown to extend drug release into the knee joint for our target of 6 months and beyond, while limiting systemic exposure.
STEP UP is a multi-centre, double-blind, placebo-controlled clinical trial that will enroll 32 patients with moderate to severe knee OA between the ages of 40-80 years. Patients will receive a single 15 mg injection of EP-104IAR (or placebo) in one affected knee and be followed for up to 42 weeks or until their knee returns to its prior level of pain. The main purpose of the study is to profile the safety and pharmacokinetics of EP-104IAR, and may also provide some preliminary insight into the duration and degree of pain relief.
The trial represents a key milestone in the history of Eupraxia. “STEP UP is the first clinical trial for Eupraxia, but certainly not the last. Through this first-in-human study, we hope to gain a better understanding of the safety, pharmacokinetics and potential efficacy of EP-104IAR that will help direct our subsequent clinical program,” said Eupraxia CEO Dr. James Helliwell. “What is more, our extended release technology has substantial platform potential. We are currently researching applications using a number of existing drugs across several disease indications. Our team looks forward to providing significant benefit to patients with pain including in osteoarthritis.”
The trial, which has a Health Canada CTA approval, will be conducted across two sites in London, Ontario, Canada by Dr. Alan Getgood (Assistant Professor at the Schulich School of Medicine & Dentistry at Western University and Orthopaedic Surgeon at the Fowler Kennedy Sport Medicine Clinic) and Dr. Rob Petrella (Professor in Family Medicine and Kinesiology at Schulich Medicine & Dentistry and Western University, located at the Western Center for Public Health and Family Medicine, and Scientist at Lawson Health Research Institute). Results are anticipated in 2017.
Osteoarthritis is a progressive joint disease that affects over one-third of people over the age of 65 and rates as one of the top five most disabling conditions. In the US alone, more than 25 million individuals are affected by OA, with health care costs exceeding $40 billion annually, not including indirect costs related to lost productivity.
Current treatments suggest a high unmet medical need for OA associated pain. Intraarticular hyaluronan injections are well tolerated, but are not recommended by the National Institute for Health and Clinical Excellence due to limited efficacy. Injections of standard corticosteroids are effective in pain control, but have a short duration of effect and potential safety complications.
EP-104IAR is a first-in-class, sustained release, non-opioid, intra-articular treatment for pain associated with moderate to severe OA of the knee. In EP-104IAR, fluticasone propionate (a potent and commonly used corticosteroid used in products such as Flonase®) is coated with a biocompatible polymer to extend the release of the drug into the knee joint. In preclinical studies, EP-104IAR was generally well-tolerated and showed sustained drug delivery for up to 10 months.
About Eupraxia Pharmaceuticals Inc.
Eupraxia Pharmaceuticals Inc. is a Canadian privately owned specialty pharmaceutical company that leverages its proprietary technologies to optimize drug delivery. We are currently advancing a portfolio of injectable drug candidates that have the potential to provide sustained drug release over a variety of indications.
About Lawson Health Research Institute
As the research institute of London Health Sciences Centre and St. Joseph’s Health Care London, and working in partnership with Western University, Lawson Health Research Institute is committed to furthering scientific knowledge to advance health care around the world. www.lawsonresearch.ca