Entera Bio advances EB613 toward Phase 3 osteoporosis trial, targets late 2026 site activation

Entera Bio Ltd. reported financial results and business updates for the quarter ended September 30, 2026, in a release dated November 6, 2026. The company said its team is focused on ensuring a seamless trial launch, with expected first site activation in late 2026.¹

The planned Phase 3 study of EB613, an oral PTH(1-34) tablet for osteoporosis, is expected to enroll approximately 900 postmenopausal women with osteoporosis, randomized 2:1 to EB613 (N ~ 600) or placebo (N ~ 300), with eligible participants aged 50-90 years and at least 5 years from the last menstrual period, diagnosed by DXA with BMD T-score of -2.5 or lower at the lumbar spine, total hip, or femoral neck.¹ In June 2026, Entera announced that the FDA accepted its proposed registrational development plan for EB613, with a primary endpoint of percent change from baseline in total hip BMD at Month 12.¹ The NDA package will include a bridging analysis with Forteo (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway.¹ Entera is preparing to activate the first clinical site in late 2026, with topline results anticipated in the second half of 2028.¹

At ASBMR 2026 in October, Entera presented new Phase 2 post-hoc analysis showing enhanced changes in bone turnover markers in women with T-scores of -2.5 or lower.¹

For EB612, developed with OPKO Health for hypoparathyroidism, the company is conducting IND-enabling studies and plans to initiate a Phase 1 single ascending dose study in 2027.¹

On finances, cash and cash equivalents were $265.9 million as of September 30, 2026, with restricted cash of $6.5 million primarily designated to fund the OPKO collaboration.¹ This followed a July 2026 private placement with gross proceeds of approximately $275.0 million, led by BVF Partners L.P. with participation from new investors including Longitude Capital, Vivo Capital, TCGX, and others.¹ The company said its cash is expected to fund the Phase 3 program through topline results and NDA submission, supporting operations into 2030.¹