1. Entera presented promising data for a once-daily tablet for hypoparathyroidism. 2. The new PTH analog shows longer plasma half-life and sustained calcium elevation. 3. Currently, only injectable treatments are available, offering a significant improvement. 4. The company's N-Tab® platform could revolutionize patient compliance. 5. Entera plans to present findings at an upcoming medical conference.
FAQ
Why Bullish?
The supportive data for EB612 may increase investor confidence and demand for ENTX.
How important is it?
The article contains substantial advancements in Entera's product pipeline, likely influencing market sentiments positively.
Why Long Term?
If clinical trials continue positively, the product could become market-disruptive in future years.
Entera Bio (NASDAQ: ENTX) Advances Development of Groundbreaking Oral Therapy for Hypoparathyroidism
JERUSALEM, Dec. 22, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a front-runner in oral peptide and protein replacement therapies, has announced promising new data that bolsters the ongoing development of its innovative long-acting parathyroid hormone (PTH) analog. This research supports the advancement of its EB612 program, aiming to create the first once-daily tablet treatment for patients with hypoparathyroidism.
Revolutionary Findings from Preclinical Studies
The recent preclinical studies revealed that Entera's proprietary PTH analog achieved a significantly longer plasma half-life and sustained calcium elevation for over three days—contrasting starkly with the unmodified PTH(1-34) controls, which demonstrated no notable calcium response. Hypoparathyroidism is an atypical endocrine disorder marked by insufficient PTH production, leading to hypocalcemia and hyperphosphatemia.
- This research underscores the potential of a daily tablet regimen.
- Currently, patients require daily injections from the only approved PTH replacement therapy, YORVIPATH®.
Impact of the EB612 Program on Patient Care
Historically, treatment for hypoparathyroidism has relied on high doses of calcium and calcitriol, which can lead to complications such as elevated urinary calcium and ectopic calcification, presenting risks of nephrocalcinosis and renal failure. The EB612 program aims to alleviate these complexities by introducing a more user-friendly oral alternative.
Entera previously demonstrated significant efficacy in a Phase 2 study, where an unmodified PTH(1-34) analog administered to patients showed a 42% reduction (p=0.001) in median calcium supplement use, maintaining serum calcium levels above the threshold for hypoparathyroidism (7.5 mg/dL) throughout the trial period.
Expert Insight from Entera's Leadership
Miranda Toledano, Chief Executive Officer at Entera, remarked, “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, our goal is to provide a single, daily tablet at fixed doses to help patients and their caregivers personalize care.”
Key Details from the Study
Entera's recent studies involved both in vitro and in vivo validations of various long-acting PTH analogs using its cutting-edge N-Tab® oral peptide platform. A minipig study demonstrated several critical outcomes:
- The lead variant exhibited a significantly longer plasma half-life than the unmodified PTH(1-34) control.
- Serum calcium levels remained elevated for over three days with the proprietary analog.
- No adverse events were noted during the study, suggesting a favorable safety profile.
With these compelling data, Entera plans to present their findings at an upcoming medical conference.
About Entera Bio (NASDAQ: ENTX)
Entera Bio is at the forefront of developing oral peptide and protein replacement therapies addressing significant medical needs. Leveraging its proprietary N-Tab® technology platform, the company is navigating the evolutionary landscape of treatment standards.
Currently, Entera is progressing with a range of first-in-class oral peptide programs, including:
- EB613, an oral PTH(1-34) tablet for post-menopausal osteoporosis.
- Oral oxyntomodulin for obesity and metabolic syndromes.
- Oral GLP-2 peptide therapies for rare malabsorption conditions.
For more information, visit www.enterabio.com or follow the company on LinkedIn, Twitter, and Facebook.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements regarding Entera Bio's plans, prospects, and expected results. Such statements involve risks, uncertainties, and assumptions that could cause actual results to differ materially. Factors affecting these outcomes include changes in FDA interpretations, clinical trial data variability, and market conditions.