Eupraxia Pharmaceuticals Initiates Phase 3 Development Program for EP-104IAR
VICTORIA, BC, Feb. 1, 2024 -?Eupraxia Pharmaceuticals Inc. ("Eupraxia" or the "Company") (TSX: EPRX), a clinical-stage biotechnology company leveraging its proprietary Diffusphere? technology to optimize drug delivery for applications with significant unmet need, today announced the Company has initiated its Phase 3 development program for EP-104IAR, the Company's lead drug candidate for the treatment of osteoarthritis ("OA") of the knee, following completion of its End-of-Phase 2 meeting with the U.S. Food & Drug Administration ("the FDA").
Based on this interaction, the Company anticipates it is on track to dose the first patient in its Phase 3 program in the third quarter of 2024.
The recent End-of-Phase 2 meeting with the FDA addressed non-clinical and clinical topics, including discussions on the size of the required safety database, and the main design elements of repeat dose study and the comparative bioavailability study required to satisfy requirements for the 505(b)(2) approval pathway.
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Drug Prod Dev Professional - Preclin through Phase 4, CMC Submissions, Proj Mgmt, Tech Transfers, Process Val & Launch
1 年Yay!!! This is so exciting.