Eupraxia Pharmaceuticals Inc. Announces Authorization of Clinical Trial Application for Phase 2 Trial of EP-104IAR in Osteoarthritis of the Knee
VICTORIA, B.C. – Eupraxia Pharmaceuticals Inc. (“Eupraxia” or the “Company”) (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced the authorization of its Clinical Trial Application (“CTA”) by the Danish Medicines Agency (“DKMA”). The authorization is required to initiate the Company’s Phase 2 clinical trial for its lead candidate EP-104IAR as a potential treatment for pain from osteoarthritis (“OA”) of the knee.
The trial is being conducted by contract research organization Nordic Biosciences Clinical Development A/S (“NBCD”) and is expected to enroll its first patient in the third quarter of 2021.
“Authorization of our CTA in Denmark is an important step for the Company and EP-104IAR,” said Dr. James Helliwell, CEO of Eupraxia. “As this trial gets underway, we are also working to broaden the potential of this candidate by initiating a pre-clinical study to support repeat dosing. Our existing preclinical cartilage sparing data, combined with the potential for repeat dosing, are meaningful competitive differentiators that could support market expansion opportunities for EP-104IAR, if approved.”
Eupraxia’s Phase 2 study is a placebo-controlled, double-blind, randomized trial evaluating the efficacy and safety of EP-104IAR in 300 patients with chronic knee OA. Patients will be randomized to receive either a single injection of 25 mg EP-104IAR or placebo with a primary endpoint of change in Western Ontario and McMaster Universities Osteoarthritis Index (“WOMAC”) pain score at week 12. Secondary endpoints include change in WOMAC function at week 12 and change in WOMAC pain score at week 24. There are additional endpoints relating to quality of life, disease state and use of rescue medication.
NBCD has a proven track record in conducting OA clinical trials and will initiate the trial at multiple clinical research centres in Denmark in the third quarter of 2021, with patient recruitment continuing through spring 2022, and data readout expected in the fourth quarter of 2022.
Eupraxia has an open Investigational New Drug (“IND”) Application with the United States Food and Drug Administration (“FDA”) and NBCD maintains a global operational footprint, allowing Eupraxia to potentially expand both the current and future trials into the United States and other geographies as necessary.
Eupraxia’s lead product candidate, EP-104IAR, is designed to meet the significant unmet medical need and market demand for long-lasting pain relief for knee OA. The U.S. Centers for Disease Control and Prevention estimates that knee OA affects more than 30 million people in the U.S. alone. This includes 14 million that suffer with knee pain or some form of disability. Knee OA is also associated with depression and loss of sleep, which can greatly affect quality of life.
With EP-104IAR, Eupraxia hopes to change the way knee OA pain is treated. Current therapies are challenged by poor safety, inadequate efficacy and/or limited duration of activity. Corticosteroids are one of only two drug classes strongly recommended by the American College of Rheumatology and the Arthritis Foundation for the treatment of knee OA pain. Currently approved corticosteroids are very effective at reducing pain for a short duration but can expose the body to unwanted local and systemic side effects.
EP-104IAR is being developed to provide long-term pain relief with fewer unwanted side effects. It encapsulates a highly potent corticosteroid (fluticasone propionate) within a microns-thin polymer membrane.
Injected into the knee, EP-104IAR is intended to slowly release drug at therapeutic concentrations for up to six months. This has the potential dual advantage of providing long-duration pain relief with fewer systemic side effects. An enhanced safety profile would also benefit the estimated 70% of knee OA patients that experience pain in both knees.
EP-104IAR has completed a Phase 1 trial and is currently in Phase 2 clinical development. A modified version of EP-104IAR is under development for canine and equine OA.
Eupraxia is a clinical-stage biotechnology company focused on the development of locally delivered, extended-release alternatives to currently approved drugs. Each of Eupraxia’s product candidates has the potential to address therapeutic areas with high unmet medical need and strives to provide improved patient benefit by delivering targeted, long-lasting activity with fewer side effects.
Eupraxia’s lead product candidate, EP-104IAR, is currently in Phase 2 development for the treatment of pain due to OA of the knee. In addition to EP-104IAR, Eupraxia is developing a pipeline of earlier-stage long-acting formulations. Potential pipeline candidates include a range of drugs for indications such as post-surgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. Eupraxia is also developing a formulation of EP-104IAR for use in canine and equine OA.
For further details about Eupraxia, please visit the Company’s website at: www.eupraxiapharma.com
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