Entera Bio wins FDA agreement to use BMD as primary endpoint for EB613 Phase 3 osteoporosis study

Entera Bio Ltd.

• FDA agreed single 24-month, placebo-controlled Phase 3 study with total hip BMD as primary endpoint; fracture incidence as key secondary.
• Shift from traditional fracture-endpoint trials; no dedicated oral carcinogenicity or DART studies required by FDA.
• Phase 3 study targets postmenopausal women; EB613 is first oral anabolic tablet for osteoporosis.
• FDA's SABRE qualification still expected later this year but not needed to proceed.
• CEO Miranda Toledano calls it a major milestone; no new osteoporosis drug approved by FDA since 2019.