Eupraxia Pharmaceuticals Completes Patient Enrollment for its Phase 2 Trial in Knee Osteoarthritis
- Company remains on track for Phase 2 data readout in Q2 2023 -
VICTORIA, BC, Dec. 7, 2022 /CNW/ - 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 that it has completed enrollment, randomization and dosing of the last patient, in its Phase 2 trial that is evaluating the efficacy and safety of EP-104 for the treatment of osteoarthritis ("OA") of the knee.
"Eupraxia has successfully achieved another important clinical milestone in our ongoing Phase 2 trial, removing patient accrual risk by dosing our last patient," said Dr. James Helliwell, CEO of Eupraxia. "The entire team has worked tirelessly to fully enroll the study during a time when many biotech companies are facing challenges enrolling trials. With this important step behind us, we remain confident in our ability to report top-line trial results in the second quarter of 2023."
The trial's primary endpoint is the difference in change from baseline between EP-104 and placebo in the Western Ontario and McMaster Universities Osteoarthritis Index ("WOMAC") pain subscale at 12 weeks, with a key secondary endpoint at 24 weeks. Additional key secondary endpoints include the difference in change from baseline between EP-104 and placebo in the WOMAC function subscale.
A magnetic resonance imaging ("MRI") sub-study was also added to the trial's protocol late in the enrollment period to further characterize the safety profile of EP-104 and potentially strengthen EP-104's differentiation as a treatment for OA.
Eupraxia also continues to advance its ongoing Phase 1b/2a trial evaluating EP-104's safety and efficacy as a treatment for eosinophilic esophagitis ("EoE"), with data from the trial expected to begin reading out in the first half of 2023.
Eupraxia's lead product candidate, EP-104, is designed to meet the significant unmet medical need and market demand for long-lasting disease relief in multiple indications benefitting from highly localized and longer delivery of corticosteroids. The lead indication is for pain relief in 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-104, 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 late in the disease but can expose the body to unwanted local and systemic side effects.
EP-104 endeavours 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, part of Eupraxia's proprietary technology platform.
Injected into the knee, EP-104 is intended to diffuse drug slowly into the knee joint providing 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 by allowing simultaneous treatment of both affected joints.
In contrast to immediate release steroids, a non-clinical study of EP-104 suggests a cartilage sparing effect, which could provide a safer treatment alternative for those afflicted with chronic OA pain. The product has also been designed with physician convenience in mind – targeting a long shelf life, no refrigeration and easy integration into existing delivery techniques.
The potential advantages of EP-104 are central to the expansion into EoE and other indications. EoE is a localized inflammatory disease of the esophagus that has relied primarily on swallowing steroids (often off-label compounded versions) to control disease symptoms. Eupraxia hopes that a localized administration of an extended-release steroid will offer patients an effective treatment option that lasts for months instead of hours.
About Eupraxia Pharmaceuticals Inc.
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-104, is currently in Phase 2 development for the treatment of pain due to osteoarthritis of the knee. The EP-104 platform has expanded into gastrointestinal disease with the launch of a Phase 1b/2a program to treat eosinophilic esophagitis. Eupraxia is also developing a pipeline of later- and earlier-stage long-acting formulations. Potential pipeline indications include candidates for both other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.
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SOURCE Eupraxia Pharmaceuticals Inc.
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