Company: ENTXW
Filing Date: 2025-11-14
Form Type: 10-Q
Source: 0001178913-25-003852
Chunk: 14

Company: Entera Bio Ltd.
Filing Date: 2025-11-14
Form: 10-Q
Item: Part I, Item 2
Chunk 14
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opausal 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 qualification. In September and April 2025, the effects of EB613 on trabecular and cortical bone indices based on a 3D-Shaper DXA post-hoc analysis of Phase 2 results were presented at the American Society for Bone and Mineral Research (“ASBMR”) 2025 Annual Meeting and the 2025 World Congress on Osteoporosis, respectively. The data using 3D-DXA modelling showed that after six months of treatment, EB613 2.5 mg demonstrated significant increases in both trabecular and cortical bone parameters as compared with placebo. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613.

In October 2025, we reported clinical data from a post-hoc analysis of our Phase 2 trial of EB613, at the 2025 North American Menopause Society (NAMS) Annual Meeting in a poster presentation titled “EB613 (Oral PTH[1-34] Tablets) Increases BMD Over six Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial (P-66)”. In this analysis of the Phase 2 trial, EB613 produced significant and consistent gains in BMD at the spine, femoral neck and hip in women within 10 years of menopause, with improvements comparable to those observed in women more than 10 years post-menopause.

In parallel, a new generation of EB613 is being developed with our N-Tab™ platform. At the ASBMR Annual Meeting in September 2025, preclinical data for our Next-Gen EB613 candidate from a cross-over pharmacokinetic mini-pig study was presented. This  pre-clinical data showed comparable PK to the current formulation of EB613. We initiated a Phase 1 Safety and PK Study in November 2025 which will also serve as a first in man study of this new generation of EB613.

EB612 Program

Our product candidate, EB612, is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for patients with hyp