EB613

October 13, 2026: Entera Bio Ltd. (NASDAQ: ENTX) reported ASBMR 2026 poster data and Phase 3 design details for EB613 (oral PTH(1-34)) in postmenopausal osteoporosis.

For EB613 Phase 2, a post-hoc analysis of the 161-patient, 6-month randomized study found larger placebo-adjusted BMD gains with EB613 2.5 mg daily in women with baseline T-scores ≤-2.5 versus >-2.5. At 6 months, women with T-scores ≤-2.5 had mean placebo-adjusted BMD increases of 4.23% at total hip (n=6) and 4.22% at lumbar spine (n=9), versus 1.02% (n=15) and 1.59% (n=12) in women with T-scores >-2.5; pooled across 21 EB613-treated participants, increases were 1.84% at total hip and 2.72% at lumbar spine. P1NP and CTX changes were also larger and more persistent in the lower-BMD subgroup. The company described the analysis as exploratory and hypothesis-generating, supporting EB613 use in women at high fracture risk.

Entera also presented the registrational Phase 3 design: a multinational, randomized, double-blind, placebo-controlled study in about 900 postmenopausal women with osteoporosis, randomized 2:1 to EB613 or placebo for 12 months. The primary endpoint is Month 12 total hip BMD change; secondary endpoints include lumbar spine and femoral neck BMD at Months 3, 6, and 12, with an extension study through Month 24.