Oral peptide and protein replacement therapies

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Entera Bio to Unveil Clinical and Non-Clinical Data Across 3 Oral Peptide Programs at Upcoming September Conferences
Globenewswire· 2025-08-28 12:00
Osteoporosis Program: Phase 2 analysis exploring the dual actions of oral PTH(1-34) tablet treatment, EB613 on trabecular and cortical bone, and Next-Gen EB613 PK/PD data slated for oral and poster presentations at ASBMRShort Bowel Syndome and Rare GI Disorders: PK/PD of oral GLP-2 tablet candidate poster presentation at ESPENCorporate Overview at H.C. Wainwright Investor Conference JERUSALEM, Aug. 28, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and ...
Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates
Globenewswire· 2025-08-08 20:05
Core Insights - Entera Bio Ltd. has achieved a significant milestone with the FDA's agreement to use Bone Mineral Density (BMD) as the primary endpoint for the Phase 3 program of EB613, marking a step towards the first oral anabolic osteoporosis treatment [2][4][5] - The company reported a cash position of $18.9 million as of June 30, 2025, which is expected to support operations through mid-Q3 2026 [9][10] - Entera is advancing multiple programs, including the oral GLP-1/glucagon dual agonist in collaboration with OPKO Health, and is preparing for a Phase 1 study of the next-generation EB613 [2][4][14] Financial Results - For the quarter ended June 30, 2025, Entera reported a net loss of $2.7 million, or $0.06 per share, compared to a net loss of $2.1 million, or $0.06 per share, for the same period in 2024 [10][19] - Research and development expenses increased to $1.5 million from $1.1 million year-over-year, primarily due to regulatory activities and Phase 3 planning for EB613 [10][11] - Total operating expenses for the quarter were $2.7 million, up from $2.2 million in the previous year [11][19] Business Updates - The FDA has waived additional safety studies for EB613, allowing for a streamlined pathway to market [4][5] - Entera's collaboration with OPKO Health is showing strong momentum, particularly in obesity and hypoparathyroidism programs [2][4][14] - The next-generation EB613 is expected to enter Phase 1 clinical trials in November 2025, utilizing Entera's proprietary N-TAB™ technology [4][12]
Entera Bio Announces First Quarter 2025 Financial Results and Business Updates
Globenewswire· 2025-05-09 20:05
Core Insights - Entera Bio Ltd. reported financial results and business updates for Q1 2025, highlighting progress in its oral peptide and protein replacement therapies, particularly EB613 for osteoporosis and Oral OPK-88006 for metabolic diseases [1][2][12]. Financial Performance - As of March 31, 2025, Entera had cash and cash equivalents of $20.6 million, with $8 million allocated for collaboration with OPKO, expected to sustain operations through mid-Q3 2026 [12]. - The net loss for Q1 2025 was $2.6 million, or $0.06 per share, compared to a net loss of $2.0 million, or $0.05 per share, in Q1 2024 [13][21]. Product Development - EB613 is the first oral anabolic treatment for postmenopausal women with osteoporosis, with plans to initiate a Phase 1 study in H2 2025 [2][3]. - The company is preparing for a pivotal program for EB613, which has shown promising results in increasing bone mineral density (BMD) [3][4]. - Entera is also developing Oral OPK-88006, a dual-acting GLP1/Glucagon tablet for metabolic diseases, with a 40% stake in its economics [2][10]. Clinical Advancements - EB613's early mechanistic effects were selected for oral presentation at the 2025 World Congress on Osteoporosis, indicating strong interest in its clinical potential [2]. - The SABRE initiative is advocating for regulatory reform to qualify BMD as a surrogate endpoint for fracture risk, which could facilitate the approval of new osteoporosis treatments [3]. Team Expansion - Entera has strengthened its core team with the appointment of Leslie Gautam as Chief Business Officer and Cherin Smith as Head of Clinical Operations, both bringing extensive experience in women's health and clinical operations [8][11].
Entera Bio’s EB613 Demonstrates Early Impact on Both Trabecular and Cortical Bone Compartments with 6 Months of Treatment in Post-Menopausal Women with Osteoporosis - Highlighted as Oral Presentation at WCO-IOF ESCEO
Globenewswire· 2025-04-15 12:30
Core Insights - Entera Bio Ltd. is developing EB613, the first once-daily oral anabolic PTH(1-34) tablet for postmenopausal women with osteoporosis at high risk for fracture [1][4] - The Phase 2 study showed significant increases in bone mineral density (BMD) at various skeletal sites compared to placebo, indicating a dual effect of stimulating bone formation and inhibiting resorption [1][2] - The company plans to initiate a Phase 3 registrational study for EB613 following positive Phase 2 results [5] Company Overview - Entera Bio is a clinical-stage company focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [5] - The company's pipeline includes five differentiated oral peptide programs targeting conditions such as osteoporosis, hypoparathyroidism, and obesity [5] - EB613 is positioned as a solution for the treatment gap in osteoporosis care, aiming to provide a simple daily tablet for patients who currently lack effective treatment options [4][5] Clinical Study Findings - The Phase 2 study randomized 161 postmenopausal women and demonstrated early effects on trabecular and cortical bone, suggesting rapid bone strengthening and fracture resistance [2][3] - 3D-DXA analysis revealed substantial improvements in areal BMD at the total hip and femoral neck, consistent with results from subcutaneous teriparatide [3] - The study's findings indicate a broad distribution of bone loss with placebo and a similar distribution of bone gain with EB613 in the femur [2] Market Context - Osteoporosis affects approximately 200 million women globally, with a significant risk of fragility fractures, particularly in postmenopausal women [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment like EB613 [4]
Entera Bio's EB613 Demonstrates Early Impact on Both Trabecular and Cortical Bone Compartments with 6 Months of Treatment in Post-Menopausal Women with Osteoporosis - Highlighted as Oral Presentation at WCO-IOF ESCEO
Newsfilter· 2025-04-15 12:30
Core Insights - Entera Bio Ltd. announced positive results from a Phase 2 study of EB613, an oral PTH(1-34) tablet aimed at treating postmenopausal women with osteoporosis at high risk for fractures [1][2][4] - The study demonstrated significant increases in bone mineral density (BMD) across various skeletal sites compared to placebo, indicating the potential for rapid bone strengthening and fracture resistance [2][3] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product, EB613, is positioned as the first oral anabolic treatment for postmenopausal women with low BMD and high-risk osteoporosis [5] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] Study Details - The Phase 2 study involved 161 postmenopausal women and assessed the effects of EB613 over 6 months, showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD compared to placebo [2][3] - 3D-DXA analysis indicated a dual effect of EB613, stimulating bone formation while inhibiting resorption, with significant improvements noted in both trabecular and cortical bone [1][2] Market Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment option like EB613 [4]