Eden Biologics today announced completion of enrollment for Phase 1 PK Clinical Trial of Eden's lead product candidate EB1001, a Denosumab biosimilar.
HSINCHU, TAIWAN, February 25, 2021 /EINPresswire.com/ — Eden Biologics, Inc., a global frontrunner in biological drug development and manufacturing platform technologies, today announced completion of enrollment for their Phase 1 comparative PK Clinical Trial (JHL-CLIN-1266-01) of Eden's lead product candidate EB1001, a Denosumab biosimilar, for the future treatment of osteoporosis, giant cell tumors of bone, and other skeletal-related events from metastatic solid tumors.
The study, a randomized, double-blind, parallel-group, single dose, three-arm study to compare the pharmacokinetic similarity of EB1001 versus Prolia®/TM sourced from EU and US in healthy human subjects was conducted in clinical sites throughout Australia and New Zealand. Eden Biologics fully anticipates initiation of the global Phase 3 in 2021.
Eden Biologics’ mission is to develop and manufacture world-class biologics at affordable prices for all patients in need and the recruitment completion of EB1001’s PK study is a big step towards this goal. In addition to achieving this milestone in early 2021, Eden is making a huge push forward with their massive portfolio of biosimilars as well as maintaining their ever-expanding CDMO business.
About Eden Biologics, Inc.
Eden Biologics is a biopharmaceutical company established in 2012 and after a transformation under new executive leadership led by James Huang, Chairman and CEO (also Managing Director of KPCB China), Eden continues to focus on three biotech sectors: 1) Accelerating the development programs for clients through the provision of Contract Development and Manufacturing Services (from cell line development to commercial manufacturing with regulatory filing support; 2) Developing a Proprietary Biosimilar Pipeline; and 3) Collaborating & Licensing of New and Innovative Biologics.
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Source: EIN Presswire