相关临床试验
6
0 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
2010
已完成
6
100.0%
暂无批准数据
- Entera Bio raised approximately $275 million in an oversubscribed private placement, more than 27 times its prior $10 million raise, extending its cash runway into 2030. - The funds will fully finance a 750-patient Phase III registrational trial of EB613, an oral PTH(1-34) tablet for postmenopausal osteoporosis, with topline data expected in H2 2028. - EB613 aims to become the first oral osteoanabolic tablet, replacing daily subcutaneous teriparatide injections, following positive Phase II results and FDA feedback on trial design. - Proceeds will also advance EB612, an oral PTH analog for hypoparathyroidism co-developed with OPKO Health, toward a Phase I trial with an IND filing targeted for late 2026.
- Opko Health and Entera Bio expanded their partnership on February 4 to advance the first oral long-acting PTH analog treatment for hypoparathyroidism patients as a once-daily tablet. - The companies established equal 50% ownership and cost-sharing for the LA-PTH hypoparathyroidism program while accelerating development timelines. - An Investigational New Drug application with the FDA is expected to be filed in late 2026 for this novel oral peptide therapy.
- Entera Bio's proprietary long-acting PTH analog achieved sustained calcium elevation for over three days from a single oral tablet in preclinical studies, supporting once-daily dosing potential. - The novel PTH analog demonstrated markedly longer plasma half-life compared to unmodified PTH(1-34) controls, which showed no calcium response in the minipig study. - This development represents a significant advancement from Entera's previous Phase 2 study that required four-times-daily dosing, potentially transforming treatment for hypoparathyroidism patients. - The breakthrough could offer the first oral alternative to current daily injections, addressing a major unmet need in this rare endocrine disorder affecting calcium metabolism.
- Entera Bio will present Phase 2 data for EB613, the first once-daily oral anabolic tablet for postmenopausal osteoporosis, showing rapid BMD increases at both cortical and cancellous bone sites. - The company plans a global Phase 3 registration study for EB613 following FDA alignment in July 2025, targeting the significant unmet need in osteoporosis treatment. - Data on next-generation EB613 utilizing proprietary N-Tab technology and a first-in-class oral GLP-2 analog for short bowel syndrome will also be presented at ASBMR and ESPEN conferences.
- The FDA has agreed to accept bone mineral density (BMD) as the primary endpoint for Entera Bio's Phase 3 trial of EB613, marking a significant shift from traditional fracture-based endpoints in osteoporosis drug development. - This regulatory breakthrough allows for a smaller, shorter trial with just 400 patients over 24 months, reducing development costs by an estimated 70% compared to traditional fracture studies requiring 10,000+ patients. - EB613 is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, potentially addressing poor adherence rates of current injectable therapies in the $2.3 billion anabolic therapy market. - The decision is supported by SABRE initiative data showing that a 1% increase in total hip BMD corresponds to a 12-15% reduction in fracture risk, with a correlation strength of R² = 0.73.
- OPKO Health and Entera Bio announced that new pharmacologic and pharmacokinetic data for their investigational oral OPK-88006 tablet will be presented at the ENDO 2025 annual meeting. - The companies are developing a proprietary dual agonist GLP-1/glucagon peptide as both a once-daily tablet and weekly subcutaneous injection for patients with obesity and metabolic disorders. - The oral program combines OPKO's long-acting oxyntomodulin analog with Entera's N-Tab technology, with IND applications planned for later this year. - The treatment aims to provide durable, sustainable weight loss and help prevent comorbidities such as severe fatty liver and sleep apnea.
- OPKO Health and Entera Bio have formed a collaboration to advance the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet for obesity, metabolic and fibrotic disorders. - The partnership combines OPKO's proprietary long-acting oxyntomodulin analog with Entera's N-Tab™ technology, with an IND application expected to be filed with the FDA later this year. - Under the agreement, OPKO will hold 60% ownership and Entera 40%, with OPKO investing $8 million in Entera shares to fund development through Phase 1 clinical trials.
• Entera Bio's EB613, an oral PTH(1-34) tablet for post-menopausal women with osteoporosis, shows promising comparative pharmacological data presented at ASBMR 2024. • Topline results for the oral oxyntomodulin (OXM) tablet program, a GLP-1/glucagon agonist for obesity, demonstrate significant systemic exposure and glucose reduction. • Entera Bio is advancing its oral GLP-2 tablet for Short Bowel Syndrome and EB612 for hypoparathyroidism, both in collaboration with partners. • The company's cash and cash equivalents totaled $6.9 million as of September 30, 2024, expected to fund operations into the third quarter of 2025.
• Entera Bio and OPKO Health reported positive pharmacokinetic/pharmacodynamic (PK/PD) results for their oral oxyntomodulin (OXM) tablet candidate targeting obesity and metabolic disorders. • In vivo studies in rodent and pig models demonstrated significant systemic exposure and favorable bioavailability of oral OXM following a single dose. • Oral OXM significantly reduced plasma glucose levels in rats post-glucose administration compared to placebo, indicating potential pharmacologic effect. • The companies plan to present the data at an upcoming clinical conference and advance the program toward IND-enabling efforts.
