Entera Bio Data for EB613 Effects on Trabecular and Cortical Bone in Post-Menopausal Women with Osteoporosis Selected for Oral Presentation at ASBMR 2025 Annual Meeting

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX) announced that new data for its EB613 oral PTH(1-34) tablet for osteoporosis treatment will be presented at the ASBMR 2025 Annual Meeting. The Phase 2 study involved 161 postmenopausal women with low bone mass or osteoporosis, testing four dose levels against placebo for 6 months.

The study demonstrated that EB613 significantly increased BMD at measured skeletal sites compared to baseline and placebo, with biochemical markers suggesting dual effects of stimulating formation and inhibiting bone resorption. The company aims to develop EB613 as the first once-daily oral anabolic treatment for postmenopausal women with high-risk osteoporosis.

Insights

Medical Researcher specializing in Osteoporosis

Entera's oral PTH tablet shows promising dual action on bone formation and resorption, potentially addressing major treatment gaps in osteoporosis care.

Entera Bio's selection for oral presentation at ASBMR 2025 represents a notable advancement for their lead candidate EB613, which aims to become the first oral anabolic (bone-forming) PTH tablet for osteoporosis treatment. The presentation will focus on 3D-DXA analysis of their Phase 2 study involving 161 postmenopausal women treated across multiple dose levels for 6 months.

The preliminary Phase 2 data appears promising, with reported increases in bone mineral density (BMD) at all measured skeletal sites compared to both baseline and placebo. More significantly, the biochemical marker data suggests EB613 may have a dual mechanism - simultaneously stimulating bone formation while inhibiting bone resorption. This dual action could potentially differentiate it from existing anabolic therapies.

The use of advanced 3D-Shaper software analysis allows for more detailed examination of drug effects on both trabecular (inner, spongy) and cortical (outer, dense) bone components. This granular understanding of treatment effects is critical as both bone components contribute differently to overall bone strength and fracture risk.

The development of an oral PTH therapy addresses a critical gap in osteoporosis management. Current anabolic treatments require injection, creating a significant barrier to adoption despite their efficacy and presence in treatment guidelines. With approximately 200 million women affected by postmenopausal osteoporosis globally, and the serious mortality risk associated with osteoporotic fractures (about 20% die within a year following hip fracture), an effective oral option could substantially improve treatment accessibility and compliance.

JERUSALEM, June 26, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins replacement therapies, announced that new data exploring the dual actions of EB613 on trabecular and cortical bone was selected for oral presentation at the American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting, taking place September 5-8 in Seattle, Washington, USA.

EB613 is being developed as the first once-daily oral anabolic (bone forming) PTH(1-34) tablet treatment to support earlier osteoanabolic intervention for postmenopausal women with osteoporosis at high risk for fracture. The Phase 2 study randomized 161 postmenopausal women with low bone mass or osteoporosis to placebo or four EB613 doses levels for 6 months. Previously published changes in biochemical markers of bone turnover suggest a dual effect to stimulate formation and inhibit resorption. In addition, EB613 significantly increased BMD at each measured skeletal site as compared with baseline and placebo. To explore the dual actions of EB613 further, 3D-DXA analysis was performed using 3-D Shaper software to assess the effects on trabecular and cortical bone.

It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and approximately 1 in 5 adults will die within the year following a hip fracture. Postmenopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.

“We are grateful for the honor of being selected for an oral presentation at ASBMR. The 3D-Shaper analysis of our BMD findings from the Phase 2 study enabled us to further explore the mechanism of action of EB613,” said Miranda Toledano, Chief Executive Officer of Entera. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most patients with high-risk osteoporosis requiring an anabolic intervention. Our EB613 program is being developed to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of patients to adequately manage their bone health with a once daily tablet treatment,” said Toledano.

Abstract Title: 4264 - Effects of EB613 Tablets [Oral PTH(1-34)] on Trabecular and Cortical Bone Using 3D-DXA: Results from Phase 2 Study
Presentation Number: 1014
Session Title: Oral Presentations: John Carstens - Osteoporosis Treatment
Session Date/Time: Friday, September 5, 2025, 11:00 AM - 12:15 PM
Presentation Time: 11:45 AM

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 low BMD and high-risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. 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 first oral GLP-2 peptide tablet 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, Facebook, Instagram.

Cautionary Statement Regarding Forward Looking Statements

Various statements in this presentation 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 presentation 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 presentation. The information in this presentation is provided only as of the date of this presentation, 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.

Contact:

Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer
Entera Bio
Email: miranda@enterabio.com

FAQ

What are the key findings from Entera Bio's (NASDAQ: ENTX) Phase 2 study of EB613?

The Phase 2 study showed that EB613 significantly increased BMD at measured skeletal sites compared to baseline and placebo, with evidence of dual action in stimulating bone formation and inhibiting resorption.

How many patients were enrolled in Entera Bio's EB613 Phase 2 trial?

The Phase 2 study randomized 161 postmenopausal women with low bone mass or osteoporosis to either placebo or four EB613 dose levels for 6 months.

When will Entera Bio present EB613 data at ASBMR 2025?

Entera Bio will present the EB613 data on Friday, September 5, 2025, at 11:45 AM during the John Carstens - Osteoporosis Treatment session.

What makes EB613 unique in the osteoporosis treatment landscape?

EB613 is being developed as the first once-daily oral anabolic (bone forming) PTH(1-34) tablet treatment, potentially offering a more convenient alternative to current injectable anabolic treatments.

What is the market potential for Entera Bio's EB613?

The target market is significant, with approximately 200 million women globally affected by postmenopausal osteoporosis, which afflicts more women than cancer and cardiovascular disease.