Entera Submits Phase 3 Protocol Amendment To FDA For Oral Osteoporosis Therapy EB613

Entera Bio Ltd. announced that it has submitted a clinical amendment to the U.S. Food and Drug Administration for its Investigational New Drug (IND) application related to EB613, an oral formulation of parathyroid hormone PTH(1-34) (teriparatide). The amendment includes an updated Phase 3 protocol, a statistical analysis plan, and a synopsis of an open-label extension study. Entera expects feedback from the FDA within approximately 60 days.

EB613 is being developed as the first oral anabolic tablet designed to stimulate bone formation for the treatment of osteoporosis. The program combines Entera’s proprietary N-Tab oral peptide delivery platform with the clinical experience of Forteo, a subcutaneous teriparatide therapy marketed by Eli Lilly and Company that has been used for more than two decades and has an established benefit-risk profile. Entera is pursuing the same therapeutic indications currently approved for Forteo.

“This submission marks a pivotal inflexion point for Entera and potentially enables us to get EB613 to patients faster,” said Miranda Toledano, Chief Executive Officer of Entera. “Our goal with EB613 is to democratise anabolic treatment and enable millions of women and men to protect their bones earlier and potentially deter the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matter.”

The proposed Phase 3 study will be a multinational, randomised, double-blind, placebo-controlled trial enrolling approximately 750 postmenopausal women with osteoporosis. The primary endpoint will assess percentage change in total hip bone mineral density (BMD) from baseline at 12 months, rather than the previously anticipated 24-month measurement. This revised design significantly reduces the study duration and enrollment requirements while maintaining statistical power to demonstrate clinically meaningful increases in hip BMD.

Entera also plans to advance a final single-tablet formulation, Next-Gen EB613, directly into the Phase 3 trial, replacing the earlier multi-tablet version. This move is intended to streamline development and support a simpler once-daily oral dosing regimen if the therapy is approved. The company expects to initiate the Phase 3 trial in late 2026, with topline results projected for the second half of 2028.

In parallel, Entera has submitted a protocol for a 12-month open-label extension study in which participants could continue EB613 treatment for up to 24 months or transition to a standard anti-resorptive therapy. The extension study is expected to run concurrently with the regulatory review process and to provide additional long-term safety and efficacy data for the therapy.