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Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis
JERUSALEM, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered
About this update from Entera Bio Ltd.
[{"type":"text","content":"JERUSALEM, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, reports today that the American Society for Bone and Mineral Research (ASBMR) has announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on December 13, 2016, to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. “This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies. We would like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team for its significant contributions and for furthering this key initiative with the FDA,” said Miranda Toledano, Chief Executive Officer of Entera. “The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint. We have powered our proposed phase 3 study using the published SABRE quantitative thresholds which statistically correlate to reductions in vertebral, non-vertebral and all site fracture risk. Much like biomarkers and validated surrogates that are routinely used across oncology, cardiovascular and metabolic disorders, we look forward to FDA’s potential qualification of BMD for osteoporosis and to promptly advancing EB613 forward using this more ethical approach,” said Ms. Toledano. EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis. In a phase 2, 6-month, 161-patient, placebo-controlled study EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BM...