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Eupraxia Pharmaceuticals Provides Update for Phase 2 Study in Knee Osteoarthritis for Lead Drug Candidate EP-104IAR
Tuesday, November 8, 2022
Clean Safety Review from Data Safety Monitoring Board Supports Addition of Diabetes Patients into the Trial
Victoria, BC, November 8, 2022--(T-Net)--Eupraxia Pharmaceuticals Inc. (TSX: EPRX), a Phase 2 clinical-stage biotechnology company with an innovative drug delivery technology platform, today announced updates to its Phase 2 trial which is evaluating EP-104IAR's efficacy and safety for the treatment of osteoarthritis ("OA") of the knee.
James Helliwell, Director and Chief Executive Officer, Eupraxia Pharmaceuticals Inc.
"A clean safety review from our Data Safety Monitoring Board has increased our confidence in EP-104IAR's potential as a treatment for OA of the knee and has allowed us to expand the scope of our Phase 2 trial," said Dr. James Helliwell, CEO of Eupraxia. "The updates we are announcing today have the potential to generate more robust data that could support a stronger Phase 3 trial for EP-104IAR, and further differentiate the product candidate's commercial profile in the longer-term. In addition, we believe that these updates increase EP-104IAR's opportunity to become an effective chronic treatment for a chronic disease. More than ever, we are excited about EP-104IAR's potential to treat OA, a disease with limited safe and effective treatment options that affects more than 30 million people in the U.S. alone."
Updates to the Company's Phase 2 trial include:
Completion of Data Safety Monitoring Board ("DSMB") Reviews
Eupraxia announced today that its ongoing Phase 2 study has successfully completed all DSMB reviews, with no drug-related Serious Adverse Events noted, and a clean safety profile.
Inclusion of Patients with Diabetes as an Important Subgroup
The Company also announced today that based on the clean safety profile observed during the Data Safety Monitoring Board Review, it is now including patients with a diabetes diagnosis in its Phase 2 trial. Diabetics represent a meaningful percentage of patients diagnosed with OA, and inclusion of this important subgroup will provide valuable additional data to guide further drug development.
Inclusion of Magnetic Resonance Imaging in the Trial's Protocol
Magnetic Resonance Imaging ("MRI") has been added to the trial's protocol to further characterize the safety profile of EP-104IAR and could strengthen EP-104IAR's differentiation as a treatment for OA. This elective imaging component is expected to help identify EP-104IAR-induced reductions in inflammation and assess ongoing cartilage health in patients. Scans will follow patients at zero, three, six and 12 months, with a potential to include up to 50 patients. This change was implemented after the DSMB meeting and in conjunction with strong supportive pre-clinical evidence of cartilage health and joint health. The Company believes this MRI subgroup may further strengthen the pre-clinical data seen to date.
The Company also anticipates that this data will better inform its evaluation for inclusion of imaging in its planned Phase 3 program with the drug.
Dr. Helliwell commented, "We believe that a detailed visual representation of EP-104IAR's effect on knee osteoarthritis inflammation and joint morphology could be valuable in informing our Phase 3 trial design, and, on a longer-term basis, could better support physician decisions to prescribe the drug should it reach the commercial stage."
As a cumulative result of the updates to its Phase 2 trial, the Company anticipates that top-line data from the study will now be available in the second quarter of 2023. Eupraxia previously anticipated that the top-line data would read out in the first quarter of 2023.
About EP-104IAR
Eupraxia's lead product candidate, EP-104IAR, 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-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 late in the disease but can expose the body to unwanted local and systemic side effects.
EP-104IAR 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 patented technology platform.
Injected into the knee, EP-104IAR 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-104IAR 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.
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-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 postsurgical pain (EP-105), and post-surgical site infections (EP-201), each designed to improve on the activity and tolerability of approved drugs. For further details about Eupraxia, please visit the Company's website at: www.eupraxiapharma.com.
Forward-Looking Statements: Some statements in this release may contain forward-looking statement and forward looking information within the meaning of Canadian securities laws. [ MORE ] |
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