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. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, aiming to create the first once-daily tablet treatment [1][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® platform to address significant unmet medical needs [7] - The company is advancing multiple programs, including EB612 for hypoparathyroidism and EB613 for osteoporosis, with a goal of transforming the standard of care through oral formulations [7] Product Development - The EB612 program aims to provide a single, once-daily PTH tablet, addressing the dosing burden associated with current treatments that require daily or weekly injections [3][4] - Recent preclinical findings showed that the proprietary PTH analog achieved a significantly longer plasma half-life and sustained calcium elevation for over three days, compared to unmodified PTH(1-34) controls, which did not elicit a calcium response [1][9] Clinical Evidence - A previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients, although it involved a four-times-a-day dosing regimen [3] - The recent minipig study confirmed the pharmacokinetic and pharmacodynamic profile of the new PTH analog, supporting its potential for once-daily dosing [5][9] Future Plans - Entera plans to present the new data at an upcoming medical conference, indicating ongoing commitment to advancing its clinical programs [6]

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, which could lead to a once-daily oral tablet treatment [1][4] Group 1: Product Development - The proprietary PTH analog achieved sustained calcium elevation for over three days from a single oral tablet, contrasting with unmodified PTH(1-34) controls that showed no calcium response [1][8] - Entera's previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients [3] - The current preclinical data represent a significant advancement towards a single, once-daily tablet, addressing the dosing burden of existing treatments [3][5] Group 2: Market Context - Hypoparathyroidism is a rare endocrine disorder characterized by deficient PTH production, leading to hypocalcemia and hyperphosphatemia, with current treatments requiring daily or weekly injections [2] - The only approved PTH replacement treatment requires daily injections, highlighting the need for more convenient alternatives [2] Group 3: Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab platform [7] - The company is also developing other oral peptide programs targeting conditions such as osteoporosis and obesity, indicating a broad pipeline aimed at significant unmet medical needs [7]

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]

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]

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]