1. FDA qualifies total hip BMD as a surrogate endpoint for osteoporosis drugs. 2. Entera's EB613 may benefit from faster FDA approval due to this qualification. 3. Postmenopausal women represent a large, underserved market for osteoporosis treatments. 4. EB613 is the first oral peptide treatment for osteoporosis; significant demand exists. 5. Regulatory changes could lead to improved innovation in osteoporosis drug development.
FAQ
Why Bullish?
The FDA qualification enhances EB613's prospects, likely increasing ENTX's market value. Historical examples like Eli Lilly's recent FDA approvals demonstrate significant stock price gains post-regulatory news.
How important is it?
The article's focus on regulatory progress for EB613 directly affects ENTX's growth outlook, making it highly relevant to stakeholders.
Why Long Term?
The regulatory advantages for EB613 may create sustained market interest over years. Increased treatment options could result in wider acceptance and revenue growth beyond immediate gains.
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Entera Bio Celebrates FDA Qualification of Total Hip BMD as Key Regulatory Endpoint for Osteoporosis Drug Development
JERUSALEM, Dec. 23, 2025 (GLOBE NEWSWIRE) - Entera Bio Ltd. (NASDAQ: ENTX), a prominent figure in the development of oral peptide and protein replacement therapies, is pleased to announce the FDA's recent qualification of total hip bone mineral density (BMD) as a validated regulatory endpoint. This milestone supports Entera's strategic goal for the regulatory submission of its osteoporosis treatment, EB613, scheduled for July 2025.
Significance of FDA's Qualification
The FDA's approval confirms total hip BMD as a regulatory endpoint for novel osteoporosis treatments aimed at post-menopausal women at increased risk of fractures. Miranda Toledano, CEO of Entera, expressed her enthusiasm: "Since mid-2022, Entera has stood firm in our support of the SABRE initiative and the FDA's plans to effectuate this important regulatory change."
Context and Impact
Approximately 200 million women worldwide are estimated to suffer from osteoporosis, with treatment options remaining limited. Toledano emphasized the need for innovation, stating, "No new osteoporosis drugs have been approved by the FDA since 2019, primarily due to the extensive requirements for fracture endpoint studies."
Entera was the first company to gain FDA alignment, showing that a single Phase 3 study utilizing total hip BMD as the primary endpoint could effectively support a new drug application (NDA) for EB613.
Key Insights from FDA Review
- Demand for novel products with improved efficacy, tolerability, and usability.
- Urgency for faster drug development to reduce the financial and health burdens associated with osteoporosis fractures.
- The validated surrogate endpoint offers a promising regulatory pathway, addressing ethical concerns linked with osteoporosis clinical trials.
- BMD surrogate threshold effects can guide clinical trial planning with added flexibility.
About EB613: A Step Forward in Osteoporosis Treatment
EB613 (oral PTH [1-34]) is being formulated as the first oral, once-daily anabolic tablet for osteoporosis. A recent Phase 2 trial demonstrated that EB613 met all key biomarker and BMD endpoints without notable safety issues in postmenopausal women with low BMD.
The positive results indicate rapid dose-proportional enhancements in bone formation markers and significant increases in lumbar spine, total hip, and femoral neck BMD.
Understanding Osteoporosis
Osteoporosis is characterized by a decrease in bone density, making individuals more susceptible to fractures. This condition affects over 2 million individuals annually in the U.S. alone, with profound effects on health and quality of life. The total medical costs associated with osteoporotic fractures are projected to rise significantly from $57 billion in 2018 to $95 billion by 2040.
Risks Associated with Osteoporosis
- One in three women and one in five men over 50 will experience an osteoporosis-related fracture.
- Chronic pain, diminished quality of life, and increased mortality risk are common complications.
- Ethical considerations around clinical trials complicate the development of new osteoporosis treatments.
About Entera Bio
Entera Bio is a clinical-stage company dedicated to developing innovative oral peptide and protein replacement therapies. With a unique technology platform (N-Tab™), Entera's flagship product, EB613, represents a potential breakthrough in treating postmenopausal osteoporosis.
For more information about Entera Bio, visit www.enterabio.com or follow the company on its social media platforms.
Cautionary Note on Forward-Looking Statements
This press release may contain forward-looking statements regarding Entera's plans and expectations, which are impacted by several risks and uncertainties. These projections are based on current expectations and should not be construed as guarantees of future performance.