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Entera Bio Ltd Announces Operating and Financial Results for the Fourth Quarter and Year Ended December 31, 2020
‒ Achieved Primary Endpoint in EB613 Phase 2 Clinical Trial ‒‒ Final Data, Including Bone Mineral Density, Expected in Q2:21 ‒‒ FDA Approval of EB613 IND for
About this update from Entera Bio Ltd.
[{"type":"text","content":"‒ Achieved Primary Endpoint in EB613 Phase 2 Clinical Trial ‒‒ Final Data, Including Bone Mineral Density, Expected in Q2:21 ‒‒ FDA Approval of EB613 IND for the Treatment of Osteoporosis Enables Initial U.S. Clinical Trial ‒‒ Amgen Collaboration Continues to Progress; Company Evaluating Additional Molecules, Including GLP-2, in Multiple Pre-clinical Studies ‒‒ Company Strengthened Balance Sheet and Now Funded into the Second Quarter of 2022 ‒‒ Company to Host Conference Call and Webcast Today at 8:30 a.m. ET ‒ BOSTON and JERUSALEM, March 18, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced its financial and operating results for the quarter and year ended December 31, 2020 and provided an update on its clinical programs and pre-clinical programs. 2020 and Recent Highlights FDA Approval of EB613 IND and Completion of Enrollment in EB613 Phase 2 Clinical Trial in Israel: EB613, an orally delivered human parathyroid hormone (1-34) or PTH, drug candidate, is positioned to be the first oral bone building (osteoanabolic) treatment for osteoporosis. In December 2020, the U.S. Food and Drug Administration, or FDA, approved Entera’s Investigational New Drug, or IND, application for the initial US EB613 study in osteoporosis. Enrollment in the Phase 2 clinical trial in Israel was completed in November 2020 with 161 subjects. Assuming positive final results from this trial, Entera intends to meet with the FDA to discuss the design of a pivotal Phase 3 non-inferiority trial examining the increase in spine bone mineral density of EB613 compared to the increase observed with Forteo® (SC PTH 1-34) and confirm the potential for approval under the 505 (b)(2) regulatory pathway. Positive Final 3-Month Biomarker Data from Phase 2 Trial of EB613 in Osteoporosis: The Phase 2 study’s efficacy endpoints include an evaluation of biomarker data after 3- and 6-months of treatment and bone mineral density data, or BMD, after 6 months of treatment. Interim 6-month BMD data reported in August 2020 indicate EB613 has a statistically significant positive impact on lumbar spine BMD in a dose dependent manner. In the recently completed 3-month biomarker data analyses, subjects in the 2.5 mg dose group had a significant increase in bone formation biomarkers P1NP (prim...