Entera Bio Unveils Promising Phase 2 Results for EB613 Therapy
Entera Bio Presents New Findings on EB613 Therapy
Entera Bio Ltd. (NASDAQ: ENTX), renowned for its innovative oral peptide and protein replacement therapies, has exciting news to share. The company will present new clinical data concerning its Phase 2 trial of EB613 during the upcoming North American Menopause Society (NAMS) meeting. This presentation signifies a notable milestone as it's Entera’s first appearance at this esteemed event.
A Closer Look at the Phase 2 Trial Results
The Phase 2 data from EB613 focuses specifically on early postmenopausal women who present low bone mass or osteoporosis. This critical subset of patients is often a neglected area in the realm of osteoporosis treatment, as many continue to go without anabolic therapy options. The study zeroes in on the impact of the therapy on bone mineral density outcomes over a comprehensive six-month period.
Rising Risk and Underutilization of Anabolic Therapies
In her remarks, Miranda Toledano, Chief Executive Officer of Entera, highlighted a significant issue in the treatment landscape: anabolic therapies remain underutilized, primarily due to their current administration methods. "Injectable options pose a barrier for many, limiting access to effective treatment," she stated. The introduction of EB613, the first oral anabolic tablet, could transform how treatments are initiated, potentially reaching the 200 million women globally affected by osteoporosis.
Understanding the Significance of Timing in Treatment
At the NAMS meeting, Entera aims to present crucial data regarding the timing of therapeutic interventions, a key question in both clinical practice and market strategy. This could guide physicians on when to introduce anabolic therapy to patients, tapping into a demographic that is significantly at risk yet often underserved.
Details of the Presentation
Here are the essential details for those interested in the presentation:
Conference: North American Menopause Society (NAMS) Annual Meeting
Title: EB613 (Oral PTH[1-34] Tablets) Increases BMD Over 6 Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial
Presentation Number: P-66
Session Title: Poster Presentation
Session Date/Time: Thursday, October 23, 2025, 06:15 PM - 07:15 PM
Location: Windemere Exhibit Hall
Insights about EB613
Research supports that anabolic treatments are superior in lowering fracture risks for osteoporosis patients compared to anti-resorptive medications. Despite this, current anabolic offerings are limited to injection formats, deterring many eligible patients. EB613 represents a groundbreaking step forward as it is being developed as the first oral, once-daily tablet treatment for osteoporosis. In phase 2 trials involving 161 participants, the medication succeeded in meeting critical biomarker and bone mineral density (BMD) endpoints, all without significant safety concerns.
The Positive Outcomes of EB613
With administration of EB613, participants showed rapid increases in markers associated with bone formation and reductions in those associated with bone resorption. Additionally, notable increases in lumbar spine, total hip, and femoral neck BMD were recorded over the six months of treatment.
About Entera Bio
Entera is committed to pioneering oral peptide and protein replacement therapies that address pressing medical needs. The company’s innovative technology platform, known as N-Tab™, supports its mission to revolutionize the standard of care through oral formulations. The flagship product, EB613, is on track to become the first oral anabolic therapy targeting post-menopausal women at risk for low bone density. Furthermore, Entera is advancing other peptides, including the first oral oxyntomodulin for obesity and a GLP-2 peptide aimed at patients facing malabsorption challenges.
For more insights about Entera Bio's groundbreaking work and initiatives, please reach out to:
Company Contact:
Ms. Miranda Toledano
Chief Executive Officer, Entera Bio
Email: miranda@enterabio.com
Frequently Asked Questions
What is EB613?
EB613 is an oral peptide therapy developed by Entera Bio aimed at treating osteoporosis in postmenopausal women.
When will Entera Bio present its findings?
The presentation of new clinical data is scheduled for October 23, 2025, at the NAMS Annual Meeting.
Why are anabolic therapies important?
Anabolic therapies rebuild bone and reduce fracture risk, yet they are currently underutilized among eligible patients.
What were the results of the Phase 2 trial?
The Phase 2 trial demonstrated increases in bone mineral density and positive shifts in bone formation markers.
How does EB613 differ from current treatments?
EB613 is the first oral anabolic therapy, providing a more accessible treatment option compared to traditional injectable therapies.
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