Company: ENTXW
Filing Date: 2025-08-08
Form Type: 10-Q
Source: 0001178913-25-002702
Chunk: 1

Company: Entera Bio Ltd.
Filing Date: 2025-08-08
Form: 10-Q
Item: Part I, Item 2
Chunk 1
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MD”) and high-risk osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). In April 2024, the phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613; however, the BMD endpoint remained unqualified as a surrogate endpoint by the FDA. In November 2023, the American Society for Bone and Mineral Research (ASBMR) announced that the Study to Advance BMD as a Regulatory Endpoint (SABRE) project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment-related change in BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months. The EB613 osteoporosis clinical program has been developed under the auspices of this new approach to osteoporosis drug development.

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On July 28, 2025, we announced that in a written response to a Type A meeting request, the FDA agreed with our proposal that the NDA filing for EB613 (oral PTH (1-34), teriparatide) 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.

While the FDA’s anticipated qualification of SABRE is still expected in 2025, the FDA’s concurrence with our proposal allows us to advance our clinical program without having to wait for such