Entera Bio's Phase 3 program for EB613, an oral osteoporosis treatment, awaits FDA ruling on BMD as a fracture surrogate endpoint.
Entera Bio Ltd. has announced a key milestone in the development of its Phase 3 program for EB613, an oral PTH(1-34) peptide treatment for osteoporosis. The US FDA is expected to rule within 10 months on whether bone mineral density (BMD) can be used as a surrogate endpoint for fractures in new anti-osteoporosis drugs. Entera's proposed Phase 3 study for EB613 aims to meet these BMD thresholds.
March 26, 2024
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