Entera Bio Unveils Phase 1 Data for Oral PTH(1-34) Candidate EB612 in Hypoparathyroidism at ENDO 2024

JERUSALEM, June 3, 2024 – Entera Bio Ltd. (NASDAQ: ENTX), a prominent developer of orally administered peptides and small therapeutic proteins, unveiled promising Phase 1 clinical data for its hypoparathyroidism research program, EB612, at the Endocrine Society ENDO 2024 Annual Meeting. This program seeks to introduce the first oral daily tablet hormone replacement therapy (HRT) for hypoparathyroidism, a condition typically treated with daily injections by other late-stage investigational treatments like TransCon PTH from Ascendis Pharma A/S and eneboparatide by Amolyt Pharma.

Previously, Entera Bio published favorable results from a Phase 2a study, which utilized a four-times-a-day (QID) regimen of EB612 in hypoparathyroid patients. The recent Phase 1 study focused on a twice-a-day (BID) dosing strategy using their advanced N-Tab™ technology platform. EB612 contains the active peptide fragment 1-34 of human parathyroid hormone (teriparatide). Significant systemic exposure was reported with both BID administrations, demonstrating effective pharmacokinetic (PK) and pharmacodynamic (PD) measures. The study showed positive changes in serum calcium, phosphate, and 1,25(OH)2-Vitamin D levels while reducing endogenous serum PTH(1-84) levels, with no cases of hypercalcemia or serious adverse events (AEs). The only drug-related AE noted was a mild headache in two of the fifteen subjects, and no significant abnormalities were found in blood and urine tests. Vital signs remained within normal ranges.

Miranda Toledano, CEO of Entera, highlighted the significance of these findings, emphasizing the potential of their N-Tab™ platform to develop oral tablet treatments for essential peptide therapeutics. She suggested that their unmodified PTH(1-34) peptide, administered BID, could offer a viable alternative for hypoparathyroidism patients who need lifelong peptide replacement therapy but are intolerant or adverse to daily injections.

Entera Bio is a clinical-stage company dedicated to transforming the standard of care for significant unmet medical needs through oral peptide or protein replacement therapies. Their proprietary N-Tab™ technology platform supports a pipeline of five differentiated, first-in-class oral peptide programs, expected to progress through clinical stages by 2025. Their most advanced product candidate, EB613, is in development as a once-daily oral tablet to treat post-menopausal women with high-risk osteoporosis and low bone mineral density (BMD). A Phase 2 trial for EB613 met its primary and secondary endpoints, and preparation is underway for a Phase 3 registrational study aligned with the FDA’s qualification of a quantitative BMD endpoint, anticipated by January 2025.

The EB612 program is poised to become the first oral PTH(1-34) peptide replacement therapy for hypoparathyroidism. Additionally, Entera is working on the first oral oxyntomodulin, targeting GLP1 and glucagon peptides, for obesity treatment, and the first oral GLP-2 peptide tablet as a non-injection alternative for rare malabsorption conditions like short bowel syndrome, in collaboration with OPKO Health.

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