JERUSALEM - Entera Bio Ltd . (NASDAQ: NASDAQ:ENTX), a biotechnology company specializing in orally delivered peptides, announced that the U.S. Food and Drug Administration (FDA) has set a 10-month timeline to decide on qualifying bone mineral density (BMD) as a surrogate endpoint for fractures in osteoporosis drug trials. This development could significantly impact Entera's lead osteoporosis drug candidate, EB613.
The American Society for Bone and Mineral Research (ASBMR) shared this FDA communication regarding the SABRE project's proposal, which aims to use BMD as a regulatory endpoint.
Entera's EB613, an oral tablet form of PTH(1-34) for osteoporosis treatment, is designed to align with SABRE's BMD criteria. The company's Phase 2 study of EB613 showed positive results, and subsequent discussions with the FDA have informed the design of their upcoming Phase 3 trial.
Miranda Toledano, CEO of Entera, expressed optimism about EB613's potential as the first oral anabolic treatment for osteoporosis, a condition affecting an estimated 200 million women worldwide. The drug could bridge a treatment gap left by injectable options, with fracture rates on the rise and no new osteoporosis drugs approved since 2019.
The ASBMR President Laura Calvi, MD, highlighted the potential benefits of using BMD as a surrogate endpoint, which could streamline the clinical trial process for new osteoporosis treatments, leading to faster and less costly development paths.
Entera Bio is a clinical-stage company with a pipeline of oral peptide therapies targeting unmet medical needs. Their most advanced product, EB613, targets post-menopausal women with osteoporosis at high risk of fractures. The company plans to initiate a Phase 3 registrational study for EB613 by January 2025.
The information in this article is based on a press release statement from Entera Bio Ltd.
InvestingPro Insights
Entera Bio Ltd. (NASDAQ: ENTX) has garnered significant attention with its innovative approach to osteoporosis treatment through its lead drug candidate, EB613. As investors assess the company's prospects, particularly in light of the FDA's timeline for deciding on BMD as a surrogate endpoint, several financial metrics and InvestingPro Tips provide further context on Entera's market position and performance.
InvestingPro Data shows a market capitalization of $55.35 million, highlighting the company's moderate size within the biotech industry. The company's P/E Ratio stands at -5.17, reflecting its current lack of profitability. However, investors have shown optimism in the stock's growth potential, with a 1 Month Price Total Return of 48.57% and a 3 Month Price Total Return of 139.01%, signaling strong investor confidence in the near term.
Among the InvestingPro Tips, two particularly stand out for ENTX. First, the company holds more cash than debt on its balance sheet, which is a positive sign for financial stability and operational flexibility. Additionally, the stock's significant return over the last week, with a 10.62% price total return, may indicate a positive market reaction to recent developments, including the FDA's timeline announcement.
For investors seeking a more in-depth analysis, InvestingPro offers additional insights on ENTX, including tips on the company's gross profit margins, stock price volatility, and liquidity. In total, there are 11 more InvestingPro Tips available, which can be accessed for further guidance. To benefit from these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
The potential FDA decision on BMD as a regulatory endpoint could be a pivotal moment for Entera Bio, and the InvestingPro platform provides valuable tools for investors to navigate the implications of this development for the company's future.
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