Entera Bio Ltd. announced feedback from its Type D Meeting with the U.S. Food and Drug Administration 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.