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Eupraxia Pharmaceuticals Inc. Announces Authorization of Clinical Trial Application for Phase 2 Trial of EP-104IAR in Osteoarthritis of the Knee
Eupraxia Pharmaceuticals Inc. Announces Authorization of Clinical Trial Application for P...
About this update from Eupraxia Pharmaceuticals, Inc.
[{"type":"text","content":"\n \n \n \n Eupraxia Pharmaceuticals Inc. Announces Authorization of Clinical Trial Application for Phase 2 Trial of EP-104IAR in Osteoarthritis of the Knee\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n \n \n \n VICTORIA, BC\n \n ,\n \n July 19, 2021\n \n /CNW/ - Eupraxia Pharmaceuticals Inc.\n \n \n (\"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.\n \n \n 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.\n \n \n \"Authorization of our CTA in\n \n Denmark\n \n is an important step for the Company and EP-104IAR,\" said Dr.\n \n James Helliwell\n \n , 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.\"\n \n \n 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\n \n Western Ontario\n \n 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...