Entera Bio Announces New Data Supporting Further Development of a Proprietary First-in-Class Oral, Long-Acting PTH Tablet for Patients with Hypoparathyroidism (EB612 Program)
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Rhea-AI Summary
Entera Bio (NASDAQ: ENTX) reported preclinical PK–PD data for its EB612 program showing a proprietary long-acting PTH analog administered as a single oral tablet produced a markedly longer plasma half-life and sustained serum calcium elevation for >3 days in a five‑animal minipig study versus unmodified PTH(1‑34) controls, which showed no calcium response. The company said no adverse events were observed and positions the data as support for development of a once-daily oral PTH tablet for hypoparathyroidism. Entera plans to present the data at an upcoming medical conference.
Positive
- Sustained serum calcium elevation for >3 days
- Markedly longer plasma half-life versus unmodified PTH(1-34)
- Single oral tablet produced PD effect in all five minipigs
- No adverse events observed in the minipig study
Negative
- Evidence is preclinical only: minipig study with five animals
- Prior Phase 2 required QID dosing to maintain effect in humans
Details
News Market Reaction – ENTX
On Dec 22, the day this news came out, ENTX closed 6.21% above the previous close.
Data tracked by StockTitan Argus for the Dec 22 session.
Key Figures
- Calcium elevation duration
- >3 days
- Sustained serum calcium increase from single oral PTH analog tablet in animals
- Phase 2 duration
- 16 weeks
- EB612 Phase 2 study in hypoparathyroidism with unmodified PTH(1-34)
- Phase 2 enrollment
- 19 patients
- Hypoparathyroidism patients in EB612 Phase 2 proof-of-concept trial
- Calcium supplement reduction
- 42% reduction
- Decrease from baseline in median calcium supplement use; p=0.001
- P-value
- p=0.001
- Statistical significance of 42% reduction in calcium supplement use
- Serum calcium threshold
- >7.5 mg/dL
- Maintained above lower limit for hypoparathyroidism patients in Phase 2
- Dosing frequency
- 4 times a day
- QID tablet regimen used in earlier EB612 Phase 2 study
- Animals in minipig study
- 5 animals
- Single-tablet minipig PK–PD study monitored over five days
Historical Context
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Announcement of CEO fireside chat at Evercore ISI healthcare conference.
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Q3 results with ongoing losses and going-concern language plus pipeline updates.
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Post-hoc EB613 Phase 2 analysis showing significant BMD gains in subgroups.
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Planned presentation of new EB613 Phase 2 data at NAMS 2025 meeting.
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Positive PK data for oral GLP-2 tablet showing extended half-life vs Gattex.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
parathyroid hormone medical
hypoparathyroidism medical
pharmacokinetic medical
pharmacodynamic medical
hyperphosphatemia medical
nephrocalcinosis medical
pk–pd medical
pth(1-34) medical
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Novel PTH analog achieves sustained calcium elevation for >3 days from single oral tablet, supporting development path toward once-daily alternative to daily injections
JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides and proteins replacement therapies, today announced new validating in vivo pharmacokinetic and pharmacodynamic data that supports further development of a proprietary long-acting parathyroid hormone (PTH) analog using its N-Tab® platform to create the first once-daily tablet treatment for patients with hypoparathyroidism (EB612 program). The positive preclinical findings showed the proprietary analog achieved a markedly longer plasma half-life and sustained calcium elevation for over three days - in contrast to unmodified PTH(1-34) controls, which showed no calcium response.
Hypoparathyroidism is a heterogeneous, rare endocrine disorder characterized by deficient PTH production, hypocalcemia, and hyperphosphatemia. Historically, the standard of care included high dose calcium and calcitriol supplementation. However, raising serum calcium to normal physiological levels in the absence of PTH frequently leads to elevated urinary calcium and is often associated with ectopic calcification, including nephrocalcinosis and renal failure. Today, the only approved PTH replacement treatment (YORVIPATH®) requires patients to administer injections every day, while investigational candidates may require patients to take weekly injections.
Entera previously demonstrated proof of concept data for its EB612 program using an unmodified PTH(1-34) analog and an earlier generation of its N-Tab® platform in a Phase 2, 16-week study which enrolled 19 patients with hypoparathyroidism. The Phase 2 study (JBMR, 2021) demonstrated a
“Our focus for the EB612 program has been finding the right long-acting, proprietary PTH analog to develop a single, once-a-day PTH tablet treatment for patients with hypoparathyroidism. Given the heterogeneity of this condition which requires PTH as a replacement therapy, our goal is to provide a single, daily tablet at fixed doses to help patients and their caregivers personalize titration and long-term care,” said Miranda Toledano, Chief Executive Officer at Entera.
Key Study Details
Entera conducted in vitro and in vivo validation of a variety of proprietary long-acting PTH analogs with a new generation of its N-Tab® oral peptide platform. A confirmatory minipig study was recently completed in which a single oral tablet was administered to five animals and the PK–PD profile was monitored over five days, using an unmodified PTH(1‑34) tablet as control.
- The lead variant demonstrated a markedly longer plasma half-life compared to the unmodified PTH(1-34) control at the same dose, providing pharmacokinetic support for once-daily dosing
- Serum calcium levels increased for more than three days in all animals receiving the lead variant; the sustained elevation correlated with prolonged pharmacokinetic exposure
- Unmodified PTH(1-34) control tablets did not increase serum calcium levels
- No adverse events were observed
Entera plans to present these data at an upcoming medical conference.
About Entera Bio
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with osteoporosis at risk of fracture. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.
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 ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; 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 the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
Company Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer, Entera Bio
Email: miranda@enterabio.com
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