EB613 [hPTH(1-34) tablets] is being developed as the first once-daily oral anabolic (bone forming) mini tablet therapy for post-menopausal women with high risk osteoporosis. It is estimated that 54 million adults, representing 50 percent of the
Abstract Title: Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men
Presentation Number: SAT-456
Presentation Type: Poster Presentation
Session: Poster Session I
Session Date/Time: Saturday, October 14, 2023,
Abstract Title: First Oral hPTH(1-34) Tablet Treatment for Osteoporosis Demonstrates Rapid Pharmacodynamic Effect on Plasma Levels of Endogenous PTH(1-84)
Presentation Number: LB SUN-646
Presentation Type: Late Breaking Poster Presentation
Session: Late-Breaking Poster Session I
Session Date/Time:
Presentation Time: 1:30 pm – 3:00 pm
About
Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company’s most advanced product candidates, EB613 for the treatment of high risk, post-menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1-34), consisting of the same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. Entera is currently preparing to initiate a Phase 3 registrational study for EB613. A phase 1 PK study of novel PTH formulations was initiated in H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in the JBMR in 2019) and for another potential indication. For more information on
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Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in
Contact:Entera Bio : Ms.Miranda Toledano Chief Executive OfficerEntera Bio Email: miranda@enterabio.com
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