Business
Entera Bio Announces Q1 2023 Financial Results and Corporate Updates
JERUSALEM, May 05, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered
About this update from Entera Bio Ltd.
[{"type":"text","content":"JERUSALEM, May 05, 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 reported corporate updates and financial results for the first quarter ended March 31, 2023. “Our primary objectives for 2023 are to finalize our discussion with the FDA regarding our registrational phase 3 study for EB613 in post-menopausal women with low bone mineral density (BMD) and osteoporosis, and to update on our PK study which will assess the potential for a novel oral PTH(1-34) candidate for the treatment of hypoparathyroidism,” said Miranda Toledano, the Company’s Chief Executive Officer. “We also remain focused on our earlier stage R&D initiatives with peptides that best align to our technology, such as GLP-2.” Corporate Updates for First Quarter 2023: Concluded Type D Meeting with the FDA Related to EB613. Entera previously reported that it will continue discussions with the agency until final guidance is received on the proposed statistical evaluation of its primary endpoint. This is likely to occur pursuant to the FDA’s evaluation and qualification of the Foundation for the National Institutes of Health Bone Quality Project (FNIH BQP)1. Entera plans to provide an update on its discussions with the FDA as the year progresses. Meanwhile, the Company continues to strengthen its ecosystem of endocrinology and women’s health advisory board for EB613 with the addition of Dr. Steve Goldstein, a global leader in menopause health and former President of the North American and International Menopause Society.Institutional Review Board (IRB) Accepted and the Company Plans to Initiate Next Generation Platform PK Study in H1’2023. Topline results expected in H2’2023 including the potential for a novel candidate to treat hypoparathyroidism with once or twice a day oral PTH(1-34) tablets. This initiative builds on prior PK and Phase 2 results of an earlier generation of EB612 in hypoparathyroidism patients.Entera Oral GLP-2 Pre-Clinical Manuscript Accepted for Publication by the International Journal of Peptide Research and Therapeutics. Based on this work, Entera believes GLP-2 represents a strong candidate for its oral delivery platform and warrants further development as an injection free alternative to patients suffering from short bow...