Company: ENTXW
Filing Date: 2025-05-09
Form Type: 10-Q
Source: 0001178913-25-001674
Chunk: 8

Company: Entera Bio Ltd.
Filing Date: 2025-05-09
Form: 10-Q
Item: Part I, Item 1
Chunk 8
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-1 and GLP-2.
                     
                    Currently, most protein therapies are administered via frequent intravenous, subcutaneous, or intramuscular injections. In chronic diseases where patients require persistent management, these cumbersome, often painful and high-priced injections can create a major treatment gap.

                  From a technical standpoint, oral delivery of therapeutic proteins is challenging due to the enzymatic degradation within the gastrointestinal tract and poor absorption into the blood stream due to the proteins’ polarity and molecular weight. We leverage our N-Tab™ platform which is designed to simultaneously stabilize the peptide in the gastrointestinal tract and promote its absorption into the bloodstream.
                   
                  EB613 Program
                   
                  Our most advanced product candidate, EB613, oral PTH(1-34), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low bone mineral density (“BMD”) and high-risk osteoporosis. EB613 is intended to provide an oral anabolic treatment earlier in an osteoporosis patient’s journey to increase skeletal mass, reduce the risk of fracture and consequently limit the progression of the disease, and its associated disability and mortality. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (pharmacodynamic/bone turnover biomarker) and secondary endpoints (BMD). In April 2024, the phase 2 data was published in the Journal of Bone and Mineral Research (JBMR).

                    Following Type C and Type D meetings with the FDA, we announced in 2023 the FDA’s concurrence that a 2-year, placebo-controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support a new drug application (“NDA”) for EB613, however the BMD endpoint remained unqualified as a surrogate endpoint by FDA. In November 2023, the American Society for Bone and Mineral Research (ASBMR) announced that the Study to Advance BMD as a Regulatory Endpoint (SABRE) project team had submitted its full qualification plan to the FDA for the use of BMD as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. In March 2024, the ASBMR announced that the FDA had communicated to the SABRE project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be