Benzinga | Dec 10, 2020 08:32AM EST

Entera Bio Announces FDA Approval Of IND Application For EB613 An Oral Human Parathyroid Hormone (1-34) For Treatment of Osteoporosis

BOSTON and JERUSALEM, Israel, Dec. 10, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has reviewed the company's Investigational New Drug (IND) application for EB613, orally delivered human parathyroid hormone (1-34), or PTH and informed Entera that it may proceed with its initial U.S. clinical trial. EB613 is positioned as the first potential drug candidate that could provide a patient friendly, once daily, oral, bone building (anabolic) treatment for osteoporosis patients.



"There is a clear and compelling need for an oral PTH treatment that builds bone in patients with osteoporosis. With enrollment in the ongoing Phase 2 clinical trial of EB613 complete, we look forward to reporting the final biomarker data in the first quarter of 2021 and the final bone mineral density data from this trial in the second quarter of 2021," stated Arthur Santora, MD, PhD Chief Medical Officer of Entera. "Subject to the successful completion of the EB613 Phase 2 clinical trial, we intend to enter into a dialogue with the FDA to discuss the design of a pivotal Phase 3 clinical trial in order to ensure we meet all of the FDA's requirements for potential approval under the 505 (b)(2) regulatory pathway."

As part of the IND filing, Entera provided to the FDA data from a total of more than 70 subjects from two previously completed Phase 1 trials conducted in Israel during the development of EB613 and from an additional 35 subjects that participated in Entera's EB612 studies in Israel, including a 4 month hypoparathyroidism trial. EB613 is currently in a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low BMD, that is being conducted at four leading medical centers in Israel.