Entera Bio Receives FDA Feedback on EB613
Entera Bio announced that it has received feedback from the FDA on its Phase 3 registrational protocol for EB613, the first oral anabolic tablet in development for the treatment of osteoporosis. The FDA feedback is in response to a Clinical Amendment submitted by Entera to its investigational new drug, or IND, application, as announced in March. The FDA accepted Entera's plan to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of percent change from baseline in total hip BMD at Month 12 to support a potential new drug application submission for EB613 for the treatment of women with post-menopausal osteoporosis. The proposed NDA package will also include Entera's scientific bridge analysis with Forteo under the 505 pathway, and a transiliac crest bone biopsy sub-study in a subset of patients. The FDA also agreed with Entera's proposal to continue following the randomized patients out to 24 months in an open-label extension study under a separate protocol. Entera will plan to submit data through up to 18 months as part of the 120-day safety update to its NDA. Additionally, Entera will submit the complete 2-year data upon completion of the open-label extension study to characterize further the durability of the treatment effect, safety, and sequence data for EB613 followed by a standard anti-resorptive therapy for 12 months. The registrational study is powered to demonstrate EB613's clinical effectiveness with projected increases in total hip BMD that are comparable to reported outcomes for Forteo at 12 months, changes associated with a 60% to 80% relative reduction in vertebral fracture risk. The company plans to initiate the registrational Phase 3 study in late 2026, with topline results anticipated in the second half of 2028.
