Entera Bio Receives FDA Agreement To Support EB613 NDA Filing With Single 24-Month Global Phase 3 Study In Postmenopausal Osteoporosis, Using Total Hip BMD As Primary Endpoint And Vertebral Fracture Incidence As Key Secondary

Author: Benzinga Newsdesk | July 28, 2025 07:32am

Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of oral peptides and protein replacement therapies, announced today that in a written response to a Type A meeting request, the U.S. Food and Drug Administration (FDA) agreed with the Company's proposal that the NDA marketing application filing for EB613 would be supported by a single multinational, randomized, double-blind, placebo-controlled, 24 month phase 3 study in women with postmenopausal osteoporosis, where change in total hip BMD is evaluated as the primary endpoint, and incidence of new or worsening vertebral fractures is evaluated as the key secondary endpoint. This marks a shift from precedent placebo-controlled phase 3 studies of new osteoporosis drugs which required incidence of fracture as the primary endpoint.

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