Entera Bio's Q2 results show significant regulatory and pipeline advancements.

• FDA agrees on EB613 Phase 3 design with BMD as primary endpoint. • Streamlined pathway for oral anabolic osteoporosis treatment. • FDA waives additional safety studies for EB613. • Next-gen EB613 to enter Phase 1 in November 2025. • OPKO collaboration shows promising preclinical data. • EB612 oral PTH directed hypoparathyroidism program candidate validated. • Strong balance sheet provides runway through mid-Q3 2026.

Entera Bio Ltd. (NASDAQ: ENTX) has made significant strides in its efforts to develop oral anabolic osteoporosis treatments. The company recently received a pivotal agreement from the FDA on the design of its EB613 Phase 3 clinical trial, confirming Bone Mineral Density (BMD) as the primary endpoint and clearing a streamlined pathway for the first oral anabolic osteoporosis treatment. This regulatory milestone is a crucial step in addressing the massive unmet need in the osteoporosis treatment market.

The FDA's decision to use BMD as the primary endpoint for EB613's Phase 3 program is a significant validation of Entera's clinical data and strategic vision. The Phase 3 study, a single multinational, randomized, double-blind, placebo-controlled, 24-month study in women with postmenopausal osteoporosis, will evaluate changes in total hip BMD as the primary endpoint and the incidence of new or worsening vertebral fractures as the key secondary endpoint. This design is expected to provide substantial evidence of effectiveness and support a New Drug Application (NDA) submission.

In addition to the Phase 3 design approval, the FDA waived additional safety studies for EB613, significantly reducing the regulatory burden. This waiver is based on the totality of evidence generated from Forteo® literature and nonclinical studies conducted with EB613. The company is now poised to advance its next-generation EB613, which is expected to enter the clinic in a Phase 1 Safety and PK Study in November 2025.

Entera's collaboration with OPKO Health has also shown promising preclinical data. A poster at ENDO2025 reported pharmacokinetic data from a mini-pig study of oral OPK-88006, a dual GLP-1/glucagon receptor agonist, which demonstrated plasma levels consistent with those reported in humans for the highest subcutaneous dose of Wegovy™. This supports a once-daily tablet regimen for this first-in-class oral dual agonist, with a Phase 1 study planned and an IND filing expected in H1 2026.

The EB612 oral PTH directed hypoparathyroidism program candidate has also been validated, further strengthening Entera's pipeline. The company's strong balance sheet, with $18.9 million in cash and cash equivalents as of June 30, 2025, including $8.0 million in restricted cash designated to fund the OPKO collaboration, provides a runway through mid-Q3 2026.

Overall, these developments underscore Entera Bio's commitment to advancing innovative oral peptide and protein replacement therapies for significant unmet medical needs. The company's strategic regulatory engagement and robust pipeline position it well to execute multiple value-creating milestones across 2025 and beyond.

References:
[1] https://finance.yahoo.com/news/entera-bio-announces-second-quarter-200500050.html