Entera Bio Ltd. (NASDAQ: ENTX) disclosed that its EB612 program has generated new in‑vivo pharmacokinetic and pharmacodynamic data from a minipig study, showing a markedly longer plasma half‑life and sustained calcium elevation for over three days after a single oral tablet. The data reinforce the company’s goal of delivering the first once‑daily oral parathyroid hormone (PTH) tablet for patients with hypoparathyroidism, a rare endocrine disorder that currently requires daily subcutaneous injections of the only approved therapy, YORVIPATH.
The minipig study, conducted in early December 2025, compared the proprietary long‑acting PTH analog to an unmodified PTH(1‑34) control. The analog produced a sustained rise in serum calcium, whereas the control showed no measurable calcium response. This result is a critical step toward reducing dosing frequency, potentially improving adherence and quality of life for patients who presently rely on daily injections.
Entera’s EB612 program has already completed a Phase 2a trial that reduced calcium supplement use by 42% in 19 patients. The new preclinical data will be presented at the upcoming American Society for Bone and Mineral Research (ASBMR) Annual Meeting, scheduled for February 2026. The presentation will provide a deeper look at the pharmacokinetic profile and early safety signals that support progression to Phase 3 clinical development.
Financially, Entera Bio reported a net loss of $3.2 million in Q3 2025, with cash on hand sufficient to fund operations through mid‑Q3 2026. The company’s market capitalization stands at approximately $81.8 million. While the new data are promising, the company’s limited financial runway underscores the importance of securing additional capital or achieving regulatory milestones to sustain development momentum.
The hypoparathyroidism market was valued at $370 million in 2023 and is expected to grow as the prevalence of the condition rises and treatment options expand. YORVIPATH remains the sole approved injectable therapy, and other investigational products—such as Ascendis Pharma’s TransCon PTH and Amolyt Pharma’s eneboparatide—are still in early clinical stages. Entera’s oral approach could capture a significant share of this unmet need if the tablet demonstrates comparable efficacy and safety to the injectable standard of care.
Entera’s CEO, Miranda Toledano, emphasized that the new data “validate the long‑acting design of our oral PTH analog and bring us closer to a once‑daily oral therapy that could transform patient experience.” The company’s N‑Tab® platform, which enables oral delivery of peptide and protein therapeutics, positions Entera to expand beyond hypoparathyroidism into osteoporosis, obesity, and short bowel syndrome, further diversifying its pipeline.
The new in‑vivo data represent a pivotal milestone for Entera Bio, offering a potential breakthrough in a niche but growing market. The company’s financial position and the competitive landscape will shape the speed and feasibility of advancing EB612 toward regulatory approval.
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