Entera Bio Provides Guidance from FDA Type D Meeting Related to EB613 Pivotal Program

About this update from Entera Bio Ltd.

[{"type":"text","content":"JERUSALEM, April 03, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced feedback from its Type D Meeting with the U.S. Food and Drug Administration (FDA) related to EB613’s [daily oral hPTH(1-34), teriparatide, tablets] proposed registrational program for the treatment of postmenopausal women with osteoporosis. Entera submitted a draft phase 3 study protocol and requested the FDA’s written responses to two questions. On the first question, “Based on the FDA’s feedback provided in the Type C meeting written response August 19, 2022, and subsequent teleconference held on September 27, 2022, the Sponsor has updated the Phase 3 protocol design including the use of Total Hip Bone Mineral Density (BMD) as the primary endpoint. Does the FDA concur that the revised protocol meets its expectations?” the FDA responded that it is not opposed to the use of BMD as a surrogate for fracture, including initiating a study under the proposed Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)1 pathway, which is undergoing review. The FNIH-BQP approach to BMD as a surrogate endpoint for fracture was first discussed with Entera during its End of Phase 2 Meeting with the FDA (as announced in July 2022). In the Type D meeting responses, the FDA confirmed to Entera that a 24-month placebo-controlled phase 3 trial with the primary efficacy analysis at 24 months is acceptable and provided some guidance on the statistical evaluation of the study. On the second question, “Does FDA agree that the design of the population PK (pharmacokinetic) and exposure response evaluation incorporated in the draft Phase 3 study protocol meets FDA expectations?” FDA responded that the Company’s proposed PK sampling scheme in the phase 3 study seems reasonable. “We thank the FDA for our Type D Meeting and their ongoing support for our EB613 program. We are very pleased that the agency has re-affirmed its acceptance of BMD as an endpoint and our placebo-controlled design. We will continue our dialogue with the FDA and we will be ready to initiate our study once the FDA provides us with final guidance on their review of the FNIH-BQP. The ethical concerns associated with placebo-controlled fracture endpoint studies in...

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