Entera Bio Ltd. (ENTX) received positive FDA feedback on its planned 12-month registrational Phase 3 study of EB613, positioning the program for a potential New Drug Application based on one pivotal trial.
Osteoporosis is a chronic, progressive condition in which bone loss outpaces bone formation, leading to weakened bones and a higher risk of fractures. It affects millions of postmenopausal women, with hip, spine, and wrist fractures contributing to long-term disability and increased mortality.
Phase 3 Study Design and FDA Feedback
The FDA accepted Entera's plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial enrolling approximately 750 postmenopausal women with osteoporosis. The primary endpoint will measure percent change from baseline in total hip bone mineral density (BMD) at Month 12.
The agency also agreed with Entera's proposal to follow patients for 24 months in an open-label extension to further characterize durability, safety, and sequencing with anti-resorptive therapy.
Entera expects to submit its NDA based on 12-month data, with the 18-month dataset included in the 120-day safety update.
Scientific Bridge and Regulatory Pathway
The NDA package will include a scientific bridge analysis with Forteo (teriparatide SC injection, Eli Lilly) under the 505(b)(2) pathway, along with a transiliac crest bone biopsy sub-study.
The Phase 3 study is powered to demonstrate BMD improvements comparable to reported outcomes for Forteo, which have been associated with a 60%-80% reduction in vertebral fracture risk.
Supporting Phase 2 and Phase 1 Data
Entera previously completed a placebo-controlled, 6-month, Phase 2 study in 161 postmenopausal women, which met its primary and secondary endpoints, showing statistically significant increases in lumbar spine, total hip, and femoral neck BMD.At ENDO 2026, comparative Phase 1 data demonstrated that the single-tablet EB613 formulation achieved pharmacokinetic and pharmacodynamic profiles comparable to both the multi-tablet EB613 and Forteo.
Company Commentary
"We are grateful to the FDA for their support of our program. Entera has a clear and optimized registrational path with the aim of getting EB613 to women with osteoporosis," said CEO Miranda Toledano.
She added that the company's goal is to "democratize anabolic treatment" by offering the first oral option in a therapeutic class currently limited to injectable products.
Program Outlook
Entera plans to initiate the Phase 3 study in late 2026, with topline results expected in the second half of 2028.
EB613 is being developed as the first oral, once-daily osteoanabolic tablet, aiming to expand access to anabolic therapy for patients who may not use injectable options.
ENTX has traded between $0.91 and $3.22 over the past year. The stock is currently trading at $1.43, up 18.18%.
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