BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on
“This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies. We would like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team for its significant contributions and for furthering this key initiative with the FDA,” said
EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis. In a phase 2, 6-month, 161-patient, placebo-controlled study EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD in postmenopausal women with low mass or osteoporosis and no prior fracture. In
About ASBMR-FNIH SABREi
Initiated in 2013, the
About the Cures Act
The 21st Century Cures Act (Cures Act), signed into law on
The law builds on
It also provides new authority to help FDA improve our ability to recruit and retain scientific, technical, and professional experts and it establishes new expedited product development programs.
About
Entera focuses on significant unmet medical needs where an oral tablet form of a peptide treatment or protein replacement therapy holds the potential to transform the standard of care. The Company’s oral PTH (1-34) teriparatide mini tablets have been administered to a total of 240 subjects (153 patients) across Phase 1 and Phase 2 studies, with demonstrated bioavailability and clinical benefit across two distinct diseases. The Company’s most advanced product candidate, EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613. EB612 is being developed as the first tablet peptide replacement therapy for the treatment of hypoparathyroidism. The Company is currently conducting a phase 1 PK study of novel PTH formulations using its proprietary, next generation oral delivery platform with data expected in the second half of 2023. Entera is also developing oral GLP-2 peptide as an injection-free alternative for patients suffering from short bowel syndrome and other severe intestinal and malabsorption metabolic conditions and oral Oxyntomodulin (GLP1/glucagon) peptide for obesity in collaboration with OPKO Health. For more information on
Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.
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
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i https://www.asbmr.org/about/news-release-detail/asbmr-sabre-team-submits-full-qualification-plan-t
Contact:Entera Bio : Ms.Miranda Toledano Chief Executive OfficerEntera Bio Email: miranda@enterabio.com
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