Entera Bio Selected for Late Breaking Oral Presentation of Phase 2 6-Month Osteoporosis Data at ASBMR 2021 Annual Meeting
Entera Bio Ltd. (NASDAQ: ENTX) announced its selection for a late-breaking oral presentation at the ASBMR Annual Meeting, showcasing results from its Phase 2 study on EB613 for treating osteoporosis in postmenopausal women. The presentation will highlight the 6-month bone mineral density (BMD) results, confirming dose-related efficacy. Scheduled for October 4, 2021, this position aims to attract interest from potential clinical investigators and prescribers. Entera is gearing up for a pivotal Phase 3 study, as CEO Spiros Jamas noted positive peer reviews enhancing the presentation's significance.
- Successful dosing in Phase 2 study of EB613 highlighted at ASBMR Annual Meeting.
- Positive interim results from the Phase 2 trial create momentum for Phase 3 study.
- Increased visibility and credibility through a late-breaking presentation.
- None.
‒ Second of Two Presentations to be Delivered by Entera ‒
‒ Final 6-Month Bone Mineral Density (BMD) Results Show Dose-Related Efficacy ‒
BOSTON and JERUSALEM, Sept. 01, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced it has been selected by the 2021 Program Committee of the American Society for Bone and Mineral Research (ASBMR) Annual Meeting for a late breaking oral presentation titled “A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) results”. The ASBMR Annual Meeting is scheduled to take place on October 1-4, 2021, in San Diego, California. Entera was previously selected for a poster presentation of the same Phase 2 study’s 3-month results.
Details for both presentations are as follows:
3-Month Results
- Abstract Title: A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass - An Interim Three-Month Analysis
- Presentation Type: Poster Presentation
- Dates/Times:
- Biotechnology of Aging Skeleton Symposium – Thursday, September 30, 2021
- Plenary Session – 5:00 pm PT Friday, October 1, 2021
- General Session – 1:00 pm PT Saturday, October 2, 2021
- Presenter: Dr. Arthur Santora, Entera’s Chief Medical Officer
6-Month Results
- Abstract Title: A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) results
- Presentation Type: Oral Presentation
- Date/Time:
- Late Breaking: Clinical Treatment – 12:15 pm PT Monday, October 4, 2021
- Presenter: Dr. Arthur Santora, Entera’s Chief Medical Officer
“As we prepare for our pivotal Phase 3 study we expect it will be very productive to present EB613 as a promising oral alternative for the treatment of osteoporosis to physicians and clinical investigators potentially looking to participate in the study or consider prescribing EB613 upon regulatory approval. As further validation of the significance of our results, the feedback following the stringent peer review process has been very positive and according to the ASBMR, the presentation is expected to receive a lot of attention at the upcoming scientific meeting,” stated Entera CEO Spiros Jamas.
About Entera Bio
Entera is a leader in the development of orally delivered large molecule therapeutics for use in areas with significant unmet medical need where adoption of injectable therapies is limited due to cost, convenience and compliance challenges for patients. The Company’s proprietary, oral drug delivery technology is designed to address the technical challenges of poor absorption, high variability, and the inability to deliver large molecules to the targeted location in the body through the use of a synthetic absorption enhancer to facilitate the absorption of large molecules, and protease inhibitors to prevent enzymatic degradation and support delivery to targeted tissues. The Company’s most advanced product candidates, EB613 for the treatment of osteoporosis and EB612 for the treatment of hypoparathyroidism are in clinical development. The Company recently completed the Phase 2 study for EB613. Entera also licenses its technology to biopharmaceutical companies for use with their proprietary compounds and, to date, has established a collaboration with Amgen Inc. For more information on Entera Bio, visit www.enterabio.com.
Forward Looking Statements
Various statements in this release are “forward-looking statements” under the securities laws. 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 our interpretation of the complete 3-month biomarker data from the recently completed Phase 2 clinical trial of EB613, the timing of data readouts from the recently completed Phase 2 clinical trial of EB613, the full results of the Phase 2 clinical trial of EB613, and our analysis of those full results, the FDA’s interpretation and review of our results from and analysis of our Phase 2 trial of EB613, 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 impact of COVID-19 on Entera’s business operations; the potential disruption and delay of manufacturing supply chains, loss of available workforce resources, either by Entera or its collaboration and laboratory partners, due to travel restrictions, lay-offs or forced closures or repurposing of hospital facilities; impacts to research and development or clinical activities that Entera is contractually obligated to provide, such as those pursuant to Entera’s agreement with Amgen; overall regulatory timelines, if the FDA or other authorities are closed for prolonged periods, choose to allocate resources to review of COVID-19 related drugs or believe that the amount of Phase 2 clinical data collected are insufficient to initiate a Phase 3 trial, or a meaningful deterioration of the current political, legal and regulatory situation in Israel or the United States; the availability, quality and timing of the data from the Phase 2 clinical trial of EB613 in osteoporosis patients; the ability to find a dose that demonstrates the comparability of EB613 to FORTEO in the recently completed Phase 2 clinical trial of EB613; the size and growth of the potential market for EB613 and Entera’s other product candidates including any possible expansion of the market if an orally delivered option is available in addition to an injectable formulation; the scope, progress and costs of developing Entera’s product candidates including EB612 and GLP-2; Entera’s reliance on third parties to conduct its clinical trials; Entera’s expectations regarding licensing, business transactions and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s expectations regarding its expenses, revenue, cash resources, liquidity and financial condition; Entera’s ability to raise additional capital; Entera’s interpretation of FDA feedback and guidance and how such guidance may impact its clinical development plans; 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 “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s annual and current filings which are on file with the SEC and available free of charge on the SEC’s website at http://www.sec.gov. Additional factors may be set forth in those sections of Entera’s Annual Report on Form 20-F for the year ended December 31, 2020, filed with the SEC in the first quarter of 2021. In addition to the risks described above and in Entera’s annual report on Form 20-F and current reports on Form 6-K and other filings with the SEC, other unknown or unpredictable factors also could affect Entera’s results. 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 in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to Entera or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Entera cautions investors not to rely too heavily on the forward-looking statements Entera makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Entera undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
FAQ
What are the results of Entera Bio's Phase 2 study for EB613?
When is the ASBMR Annual Meeting where Entera will present?
What is the significance of the late-breaking presentation for Entera Bio?
What is the next step for Entera Bio after the Phase 2 results?
What is the focus of EB613 being developed by Entera Bio?
