Menopause Luminary, Dr. Steven R. Goldstein, Joins Entera’s Clinical and Scientific Advisory Board

Rhea-AI Summary

Entera Bio Ltd. (NASDAQ: ENTX) has announced the appointment of Dr. Steven R. Goldstein to its Clinical and Scientific Advisory Board. Dr. Goldstein, a prominent figure in menopause research, will play a crucial role in the development of Entera's EB613 program. This innovative therapy aims to provide an oral treatment for post-menopausal osteoporosis, addressing a significant medical need in women's health. The company emphasizes the importance of actively managing bone health for post-menopausal women, especially given the high mortality rates associated with untreated osteoporosis. Entera’s EB613 is designed to be the first oral osteoanabolic therapy, offering hope for improved treatment outcomes.

Positive

• Appointment of Dr. Steven R. Goldstein to the Clinical and Scientific Advisory Board, enhancing the company's expertise in women's health.
• EB613 being developed as the first oral osteoanabolic therapy for post-menopausal women, targeting a significant unmet medical need.
• Potential to address high mortality rates associated with untreated osteoporosis, improving patient outcomes.

Negative

• Challenges in clinical development and regulatory approval processes may hinder timely market entry of EB613.

JERUSALEM, April 26, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced that Steven R. Goldstein, MD, Professor of Obstetrics and Gynecology at New York University School of Medicine and former President of The International Menopause Society, the North American Menopause Society and recipient of the Clarkson Award from NAMS for lifetime achievement in menopause research will be joining its Clinical and Scientific Advisory Board (CSAB).

“We are thrilled to welcome Dr. Goldstein, a world-renowned leader in menopause and women’s health, to our CSAB and look forward to working with him along with our esteemed endocrinology experts at this critical time for our EB613 program. Gynecologists remain primary care for the millions of women in or post-menopause globally and the importance of actively managing bone health is paramount to their well-being. As potentially the first oral osteoanabolic therapy for post-menopausal women, EB613 is being developed to fulfill this promise,” stated Miranda Toledano, Chief Executive Officer of Entera.

“Osteoporosis is becoming one of the biggest medical problems of our aging population. In the U.S. for hip fractures alone, 21% of women who suffer a hip fracture will be dead within a year even after it is surgically repaired. Without surgery, the one-year mortality rate is about 70%¹. Unfortunately, much of the undertreatment of osteoporosis and the missed opportunity to reduce fractures stems from lack of oral anabolic agents. The fact that such agents require injection (either daily or monthly) causes large numbers of women to go under treated. An oral PTH analogue would be extremely useful in helping so many of these women,” stated Dr. Steven R. Goldstein.

About Entera Bio

Entera is a leader in the development of orally delivered macromolecules, including peptides and other therapeutic proteins. The Company focuses on significant unmet medical needs where a daily mini tablet form of a peptide treatment or replacement therapy holds the potential to transform the standard of care. The Company’s most advanced product candidates, EB613 for the treatment of high risk, post-menopausal osteoporosis and EB612 for the treatment of hypoparathyroidism, are in clinical development. Both EB612 and EB613 are being developed to address undertreated diseases which disproportionately afflict women. EB613 is the first oral, once daily mini tablet presentation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo®, a mainstay anabolic treatment which requires daily SC injections. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/biomarker) and secondary endpoints (BMD) in a dose dependent manner and was presented at the ASBMR 2021 Annual Conference. A phase 1 PK study of novel PTH formulations is planned for H1 2023 to ascertain feasibility of a new hypo candidate (a prior formulation had positive Phase 2a data announced in 2015 and published in JBMR 2019) and for another potential indication. For more information on Entera Bio, visit www.enterabio.com.

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 is contractually obligated to provide, such as those pursuant to Entera’s agreement with Amgen; 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 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 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 Statements 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 the company’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.

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¹ Mundi S, Pindiprolu B, Simunovic N, Bhandari M. Similar mortality rates in hip fracture patients over the past 31 years: a systematic review of RCTs. Acta Orthopaedica. 2014;85(1):54-9. doi:10.3109/17453674.2013.878831

FAQ

Who is Dr. Steven R. Goldstein and what is his role at Entera Bio?

Dr. Steven R. Goldstein is a professor of Obstetrics and Gynecology and a leader in menopause research, recently appointed to Entera Bio's Clinical and Scientific Advisory Board to support the EB613 program.

What is the purpose of the EB613 program at Entera Bio?

The EB613 program aims to develop an oral therapy for post-menopausal osteoporosis, addressing a crucial need for effective treatments in women's health.

Why is the development of an oral therapy for osteoporosis significant?

An oral therapy like EB613 could improve treatment adherence among women who are often deterred by injectable treatments, potentially reducing the high mortality rates associated with untreated osteoporosis.

What are the expected benefits of EB613 for post-menopausal women?

EB613 aims to enhance bone health and reduce the risk of fractures in post-menopausal women, addressing a significant medical issue arising from osteoporosis.