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Eden Biologics Anticipates Initiation of Global Phase 3 in 2021 H2 for Its Denosumab Biosimilar

Eden Biologics' lead product, EB1001, completed enrollment for Phase 1 PK Clinical Trial (Image from Shutterstock)

Eden Biologics' lead product, EB1001, completed enrollment for Phase 1 PK Clinical Trial (Image from Shutterstock)

Eden Biologics, Inc.

Eden Biologics, Inc.

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.
For more information, please contact us at partner@edenbiologics.com

Forward-Looking Statements
This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Eden Biologics undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements.

Yen Hsieh
Eden Biologics, Inc.
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