Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19th 2025 FDA RulingNext-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026                   Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH VariantsStrategic Partnership Discussions Advancing Across PipelineJERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide ...

Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19th 2025 FDA Ruling Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026 Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants Strategic Partnership Discussions Advancing Across Pipeline JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein ...

Core Insights - Entera Bio Ltd. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports the company's strategy for its product EB613 [1][2] - The FDA's position may simplify the regulatory pathway for Entera, allowing a single Phase 3 study with total hip BMD as the primary endpoint to support a New Drug Application (NDA) for EB613 [2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [7] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis [4][7] Industry Context - Osteoporosis affects over 200 million women globally, with a significant number remaining undertreated; no new osteoporosis drug has been approved by the FDA since 2019 [2][5] - Osteoporosis is a major public health issue, leading to over 2 million fractures annually in the US, with projected medical costs for osteoporotic fractures expected to rise from $57 billion in 2018 to $95 billion by 2040 [5] Product Development - EB613 has shown efficacy in a Phase 2 study, meeting all biomarker and BMD endpoints without significant safety concerns, indicating its potential as a novel treatment option [4] - The development of validated surrogate endpoints like BMD may facilitate faster drug development and address the ethical challenges associated with osteoporosis clinical trials [6]

Summary of Entera Bio Conference Call Company Overview - **Company**: Entera Bio - **Focus**: Development of first-in-class oral peptides, specifically targeting osteoporosis and metabolic diseases [2][34] Key Programs - **EB613**: - First and only osteoanabolic bone-building tablet treatment for postmenopausal women with osteoporosis [2][34] - Recently received FDA green light for registrational phase three study [2][34] - Aims to address the treatment gap in osteoporosis, where less than 25% of women receive treatment post-fracture [8][34] - **Other Programs**: - Long-acting PTH variants for hyperparathyroidism, with preclinical data expected by end of 2025 [3][34] - Dual agonist GLP-1 glucagon tablet treatment, IND filing planned for first half of 2026 [3][34] - GLP-2 tablet for short bowel syndrome, exploring additional indications [3][34] Clinical Development Insights - **Phase Two Data**: - EB613 showed significant improvements in bone mineral density (BMD) across spine, hip, and femoral neck [15][19] - The same 2.5 mg dose will be used in phase three trials [15][19] - **Phase Three Trial**: - Planned as a 24-month multinational study with at least 20% U.S. patient representation [29][31] - Aims to start in the first half of 2026 [31][34] Regulatory and Market Context - **FDA Engagement**: - Entera has had multiple productive meetings with the FDA, clarifying requirements for NDA submission [7][12] - The FDA's acceptance of total hip bone mineral density as a surrogate endpoint is a significant advancement for EB613 [4][10] - **Market Opportunity**: - Osteoporosis has seen little innovation in recent years, with the last approved drug being Evanity in 2019 [8][34] - Entera aims to fill this gap with a novel oral treatment that is easier for patients to use [34] Investment Considerations - **Valuation**: - Entera is positioned as an attractive investment opportunity due to its innovative approach and the potential to change osteoporosis treatment paradigms [34] - The company is focused on closing the treatment gap in osteoporosis, which is a significant unmet medical need [34] Additional Insights - **Geographic Strategy**: - The decision to include 20% U.S. patients is strategic, aiming to align with regulatory expectations while managing costs [29][30] - The company is also exploring markets in Europe and Asia, particularly in regions with high osteoporosis prevalence [30][34] - **Future Milestones**: - Anticipated phase one data for next-generation EB613 in Q1 2026 [32][34] - Plans to report on a third variant of long-acting PTH for hypoparathyroidism preclinically [32][34] This summary encapsulates the key points discussed during the conference call, highlighting Entera Bio's strategic direction, clinical advancements, and market positioning.

Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA agreeing to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 study of EB613, an oral treatment for osteoporosis [5][2] - The company reported strong Phase 2 data showing EB613's efficacy in increasing BMD in younger post-menopausal women, highlighting its potential to address a significant unmet medical need in osteoporosis treatment [5][2] - Entera's pipeline includes promising programs for obesity and short bowel syndrome in collaboration with OPKO, with preclinical data showing favorable pharmacokinetics for these oral therapies [4][6] EB613 Developments - EB613 is positioned as the first oral PTH(1-34) anabolic tablet for osteoporosis, with a Phase 3 study designed to evaluate its impact on total hip BMD and vertebral fractures [5][3] - Phase 2 results presented at major medical conferences indicate significant increases in trabecular and cortical bone indices after six months of treatment, comparable to injectable alternatives [5] - New analyses show EB613's ability to drive consistent BMD gains in younger post-menopausal women, with less than 15% of women currently willing to use existing injectable treatments [5] Financial Performance - As of September 30, 2025, Entera reported cash and cash equivalents of $16.6 million, with $8.0 million in restricted cash for OPKO collaboration [8] - The company incurred a net loss of $3.2 million for the quarter, slightly higher than the $3.0 million loss in the same period of 2024, with R&D expenses increasing to $1.6 million [9][10] - Total operating expenses for the quarter were $3.3 million, reflecting ongoing regulatory and Phase 3 preparation activities for EB613 [10] Collaboration and Future Plans - Entera is collaborating with OPKO on the GLP-2 program for short bowel syndrome, with positive pharmacokinetic data indicating a significant improvement over existing therapies [4] - The company is also developing an oral dual GLP-1/glucagon OXM tablet for obesity, with an IND submission planned for H1 2026 [6] - Next-generation EB613 is on track for a Phase 1 trial initiation in late 2025, with preclinical data validating the N-Tab™ platform [5]

Core Insights - Entera Bio Ltd. has presented new clinical data supporting the efficacy of EB613, an oral anabolic treatment for postmenopausal women, at the 2025 NAMS Annual Meeting [1][2] - EB613 is positioned as a first-in-class oral therapy that could significantly improve patient access to bone-building treatments, addressing the limitations of injectable therapies [1][4] Clinical Data Summary - In a Phase 2 trial, EB613 demonstrated statistically significant increases in bone mineral density (BMD) in early postmenopausal women, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The trial involved 161 patients and met all primary and secondary endpoints, showing rapid increases in bone formation markers and reductions in bone resorption markers [5][7] Market Potential - EB613 aims to transform osteoporosis treatment by providing an oral option that can be introduced earlier in the treatment journey, potentially increasing patient compliance and access [2][4] - The oral formulation of EB613 addresses a significant barrier in osteoporosis care, as current anabolic therapies are primarily injectable and underutilized [2][5]

Core Insights - Entera Bio Ltd. has presented new clinical data for EB613, an oral anabolic treatment for osteoporosis, demonstrating significant efficacy in increasing bone mineral density (BMD) in postmenopausal women [1][2][4] Group 1: Clinical Findings - EB613 showed statistically significant BMD increases in early postmenopausal women (≤10 years since last menstrual period) compared to placebo, with a 3.2% increase in femoral neck BMD (p=0.02) and a 2.5% increase in lumbar spine BMD (p=0.08) [3][6] - The treatment produced a 3.1% increase in lumbar spine BMD (p=0.05) and a 2.3% increase in total hip BMD (p=0.03) at six months, indicating meaningful improvements in bone strength [6] Group 2: Treatment Potential - EB613 is positioned as the first oral anabolic therapy for osteoporosis, addressing a significant barrier in osteoporosis care by providing a convenient oral option instead of injectable therapies [2][4][5] - The consistency of BMD improvements across different stages of menopause suggests that EB613 could transform osteoporosis treatment by allowing earlier intervention [2][4] Group 3: Future Developments - Entera plans to initiate a global registrational Phase 3 study for EB613 following FDA concurrence in July 2025, aiming to expand patient access to this innovative treatment [1][4]

Core Insights - Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, marking its first presentation at this event [1][2] - The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis, highlighting the potential role of EB613 in earlier treatment stages [2][3] Company Overview - Entera Bio is a clinical stage company developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [6] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, specifically targeting postmenopausal women with low bone mass [5][6] Product Details - EB613 has shown efficacy in a Phase 2, 6-month, placebo-controlled study involving 161 patients, meeting all biomarker and bone mineral density endpoints without significant safety concerns [5] - The treatment produced rapid increases in biochemical markers of bone formation and reductions in markers of bone resorption, along with increased bone mineral density in key areas [5] Market Context - Anabolic therapies for osteoporosis are underutilized, primarily due to their availability only as injections, which limits access for many eligible patients [3][5] - Entera Bio's oral formulation of EB613 has the potential to broaden access for over 200 million women worldwide living with osteoporosis, addressing a critical gap in treatment options [3][5]

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]

Core Insights - Entera Bio Ltd. is set to present data on three key programs in September 2025, focusing on oral peptide and protein replacement therapies for significant medical needs [1][4][7] Osteoporosis Program - EB613 is being developed as the first once-daily oral anabolic tablet for postmenopausal women with osteoporosis, showing rapid onset of action and increases in bone mineral density (BMD) in a Phase 2 study involving 161 participants [1][7] - A global Phase 3 registration study for EB613 is planned following alignment with the FDA, with BMD as the primary endpoint [7] Short Bowel Syndrome and Rare GI Disorders - The oral GLP-2 tablet program combines a long-acting GLP-2 agonist with Entera's proprietary N-Tab™ technology, providing an injection-free alternative for patients with short bowel syndrome and related gastrointestinal disorders [2][7] Upcoming Presentations - Entera's CEO will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 5, 2025, highlighting the company's advancements in oral peptide therapies [3][4] - Specific presentations include the effects of EB613 on trabecular and cortical bone and pre-clinical data for Next-Gen EB613 [5][6]