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Entera Bio Ltd Announces Completion of Enrollment In Phase 2 Clinical Trial of Eb613 In Osteoporosis
‒ Company Expects to Report Interim 3 Month Biomarker Data for All Enrolled Patients in Q1:21 with Final Bone Mineral Density, or BMD, Data Expected in Q2:21
About this update from Entera Bio Ltd.
[{"type":"text","content":"‒ Company Expects to Report Interim 3 Month Biomarker Data for All Enrolled Patients in Q1:21 with Final Bone Mineral Density, or BMD, Data Expected in Q2:21 ‒\n ‒ Results Expected Are Expected to Inform the Design of Potential Global Phase 3 Clinical Trial ‒ BOSTON and JERUSALEM, Israel, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, announced the completion of enrollment in the ongoing Phase 2 clinical trial of EB613. EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, positioned as the first potential oral bone building product to treat osteoporosis patients. The Phase 2 clinical trial of EB613 is a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low bone mineral density (BMD), and is being conducted at four leading medical centers in Israel. The trial was initially designed with three treatment groups including doses of 0.5mg, 1.0mg and 1.5mg. In July 2020, the Company amended the Phase 2 protocol based on a review of the 3-month interim biochemical marker and safety data from the first 80 subjects randomized. The two lower doses (0.5 mg and 1.0 mg) of EB613 were discontinued and a 2.5 mg dose of EB613 was added. The initial target enrollment was 160 subjects, with final enrollment of 161 subjects. In August 2020, the Company announced 6-month interim biomarker and BMD data from the first 50%, or 80 patients, enrolled in this trial. The data indicated EB613 has a meaningful and positive impact on lumbar spine BMD in a dose dependent manner. EB613 generated a mean placebo adjusted increase in lumbar spine BMD of 2.15% (p = 0.08) for the 14 patients in the 1.5 mg treatment arm, as compared to the 16 patients in the placebo arm. The placebo-adjusted increase was comprised of a mean BMD increase of 1.44% in the 1.5 mg treatment arm compared to a mean decrease of 0.71% in the placebo arm. An additional analysis of BMD changes in all EB613 treatment groups showed a significant dose-dependent trend in the percentage change in lumbar spine BMD. “There is a clear and compelling need for an oral PTH treatment that builds bone in patients with osteoporosis and we look forward to reporting the full topline results from this trial in the second quarter of 2021,” stated Roger Gar...