Entera

Entera Bio Reports Phase 1 Clinical Data of First-in-Class, Oral PTH(1-34) Peptide Candidate (EB612) for Patients with Hypoparathyroidism at ENDO 2024

Retrieved on: 
Lundi, juin 3, 2024
ENDO, Therapy, QID, Entera, Injection, Patient, Annual general meeting, Serum, Trial of the century, Safety, Ish-Shalom, Teriparatide, Hypoparathyroidism, Life, Hypercalcaemia, Blood, PD, PTH, Calcium, Vital signs, BID, Endocrine Society, Tablet

Entera’s EB612 program aims to provide the first oral PTH daily tablet hormone replacement therapy for patients suffering from hypoparathyroidism.

Key Points: 
  • Entera’s EB612 program aims to provide the first oral PTH daily tablet hormone replacement therapy for patients suffering from hypoparathyroidism.
  • Late stage investigational PTH replacement treatments include TransCon PTH (palopegteriparatide) by Ascendis Pharma A/S and eneboparatide (AZP-3601) by Amolyt Pharma.
  • Entera previously published positive Phase 2a study results in hypoparathyroid patients with four times a day (QID) regimen (Ish-Shalom, JBMR 2021) of EB612.
  • “The encouraging findings from this Phase 1 study reaffirm the ability of our N-Tab™ platform to develop simple oral tablet treatments of important peptide therapeutics.

Entera Bio Announces Robust Pharmacokinetic Data for First-in-Class Oral GLP-2 Peptide Tablet Treatment for Patients with Short Bowel Syndrome

Retrieved on: 
Mercredi, mars 20, 2024
Zealand Pharma, Plasma, Rat, LC-MS/MS, Short bowel syndrome, Half-life, Inflammation, Patient, Tablet, Teduglutide, POC, OPKO Health, Injection, Entera, Pharmaceutical industry

The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.

Key Points: 
  • The program is focused on developing the first and only GLP-2 peptide tablet alternative for patients suffering from short bowel syndrome and additional disorders involving mucosal inflammation and nutrient malabsorption.
  • Currently, the only approved GLP-2 agonist, which is marketed under the name Gattex® (teduglutide), requires daily sub-cutaneous injections.
  • Entera and OPKO completed a proof of concept (PoC) single dose pharmacokinetic study in rodents as the first validation for oral administration of the GLP-2 treatment.
  • This data is consistent with previously reported PK data relating to OPKO’s GLP-2 peptide’s long acting profile, which had initially been developed as a weekly subcutaneous injection.

Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development

Retrieved on: 
Mardi, novembre 14, 2023
Woman, Absorption, Annual general meeting, Bone fracture, Type, Peptide, Stress fracture, D&O, Patient, Research, Oxyntomodulin, Hypoparathyroidism, Osteoporosis, Safety, Food, Teduglutide, Fracture, Intellectual property, BMD, OPKO Health, Athlete, Society, Type D, NDA, Three Months, PTH, Risk, Insurance, Consultant, Short bowel syndrome, Appetite, Pharmacokinetics, Nutrient, SBS, Glucagon, Teriparatide, SABRE, OXM, Disease, Tablet, FDA, Obesity, Hypercalcaemia, Injection, Weight loss, Fine chemical, Pharmaceutical industry, Cryptocurrency, Jews, Entera

“Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.

Key Points: 
  • “Today, after over a year of steadfast transformation and execution, Entera stands as a premier oral peptide company.
  • We are also exploring the potential use of EB613 to accelerate stress fracture healing due to high intensity athletic or military training.
  • Entera Q3 2023 Updates and Goals for 5 Oral Peptide Programs:
    EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.
  • Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections.

Entera Bio Reports Key Milestone Relating to Oral PTH (1-34) Peptide (EB613) Phase 3 Program: ASBMR-SABRE Has Submitted to FDA the Full Qualification Plan to Approve BMD as a Surrogate Endpoint for Osteoporosis

Retrieved on: 
Jeudi, novembre 9, 2023
NDA, Osteoporosis, Woman, Food, Type, PTH, Risk, Patient, Fracture, BMD, FDA, 21st Century Cures Act, Teriparatide, Biomarker, Society, SABRE, Medical imaging, Entera

“This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.

Key Points: 
  • “This submission is critical to the future of osteoporosis drug innovation which has been hampered by ethical and cost constraints associated with fracture outcome studies.
  • We would like to sincerely acknowledge and thank the ASBMR-FNIH-SABRE team for its significant contributions and for furthering this key initiative with the FDA,” said Miranda Toledano, Chief Executive Officer of Entera.
  • “The last 15 months have been intense for Entera from a regulatory standpoint, and we believe EB613 stands as the first program to potentially avail itself of the ASBMR-SABRE BMD endpoint.
  • EB613 (oral PTH (1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for osteoporosis.

Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting

Retrieved on: 
Lundi, octobre 16, 2023
Annual general meeting, Phosphorus, Calcium, Hypoparathyroidism, Pharmacokinetics, Female, BMD, Plasma, PTH, Research and development, Risk, Bone, AUC, Young adult, Patient, Health status of Asian Americans, Bone fracture, Osteoporosis, American Society for Bone and Mineral Research, Tablet, PD, Athlete, Cmax, Pharmaceutical industry, Birth control, Woman, MD, Entera

A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera’s oral peptide delivery platform is ongoing.

Key Points: 
  • A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera’s oral peptide delivery platform is ongoing.
  • One of the first objectives of this study is to rapidly evaluate the pharmacodynamic (PD) effects of Entera’s oral PTH(1-34) tablets.
  • Abstract Title: Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men.
  • “The data showed a consistent PK profile following administration of oral EBP05 tablets in both young men and women of menopausal age.

Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes

Retrieved on: 
Mardi, septembre 12, 2023
Agreement, SBS, Injection, OXM, Pfizer, Obesity, Teduglutide, Gastrointestinal tract, Growth hormone, Glucagon, Weight loss, Health, Nutrient, OPK, OPKO Health, Absorption, Appetite, Short bowel syndrome, Colon, Permeability, Patient, Conditional sentence, Peptide, Oxyntomodulin, Fine chemical, Pharmaceutical industry, Vaccine, Entera

JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX, “Entera”) and OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (NASDAQ: OPK, “OPKO”) have entered into a Research Collaboration Agreement.

Key Points: 
  • JERUSALEM, Sept. 12, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX, “Entera”) and OPKO Biologics, Inc., a subsidiary of OPKO Health, Inc. (NASDAQ: OPK, “OPKO”) have entered into a Research Collaboration Agreement.
  • Under the terms of the Agreement, OPKO will supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology.
  • Entera recently published pre-clinical data demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections.
  • We look forward to working with Entera,” said Phillip Frost, Chairman and Chief Executive Officer of OPKO Health.

Entera Garners 2023 PropTech Breakthrough Award For “Real Estate Search Solution Of The Year”

Retrieved on: 
Mercredi, août 23, 2023
Software, Construction & Property, Networks, Data Management, Technology, Other Construction & Property, Other Technology, Residential Building & Real Estate, Artificial intelligence, AI, Investment, SFR, Property technology, Real estate, Entera

“We’re revolutionizing the way real estate investors buy, sell and operate their single family real estate investments.

Key Points: 
  • “We’re revolutionizing the way real estate investors buy, sell and operate their single family real estate investments.
  • The ‘Real Estate Search Solution of the Year’ award from PropTech Breakthrough is very meaningful as we consider ourselves to be relentless innovators,” said Martin Kay, co-founder and CEO at Entera.
  • “We're dedicated to building products and experiences that empower residential real estate buyers, sellers and service partners to successfully work together.
  • Professional capital has been moving into residential real estate, and traditional methods of investing are no longer adequate,” said Bryan Vaughn, Managing Director of PropTech Breakthrough Awards.

Entera Bio to Present Two Abstracts on its First-in-Class, Once Daily Oral hPTH(1-34) Peptide Tablets (EB613) for the Treatment of Post-Menopausal Women at High Risk of Fracture at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting

Retrieved on: 
Mercredi, août 16, 2023
Bone fracture, Osteoporosis, Cardiovascular disease, Cancer, Woman, Estradiol, Entera, Tablet, Patient, Risk, Annual general meeting, Menopause, Rare-earth element, Dietary supplement

EB613 [hPTH(1-34) tablets] is being developed as the first once-daily oral anabolic (bone forming) mini tablet therapy for post-menopausal women with high risk osteoporosis.

Key Points: 
  • EB613 [hPTH(1-34) tablets] is being developed as the first once-daily oral anabolic (bone forming) mini tablet therapy for post-menopausal women with high risk osteoporosis.
  • Due to a lower peak bone density as compared to men and decreases in estradiol after menopause, women are affected in greater numbers.
  • Post menopausal osteoporosis afflicts more women globally than cancer and cardiovascular disease and is a serious health concern.
  • As potentially, the first once daily hPTH(1-34) peptide tablet therapy, our EB613 program is dedicated to address the vast treatment gap in current osteoporosis care,” said Miranda Toledano, Chief Executive Officer at Entera.

Entera Bio Announces Q2 2023 Financial Results and Corporate Updates

Retrieved on: 
Vendredi, août 11, 2023
PK, Insurance, FNIH, PD, D&O, Osteoporosis, CMC, Hypoparathyroidism, Consultant, Entera, PTH, Tablet, Patient, Patent, Peptide, R, Research, Safety, Fine chemical, Pharmaceutical industry, Cryptocurrency

JERUSALEM, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the second quarter ended June 30, 2023.

Key Points: 
  • JERUSALEM, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today reported corporate updates and financial results for the second quarter ended June 30, 2023.
  • We expect to announce data from our Phase 1B study of our new generation platform in the second half of 2023.
  • Financial Results for the Six Months Ended June 30, 2023
    As of June 30, 2023, Entera had cash and cash equivalents of $9.1 million.
  • Operating expenses for the six months ended June 30, 2023 were $4.5 million, as compared to $7.1 million for the six months ended June 30, 2022.

PropTech Breakthrough Announces Winners Of Third Annual Awards Program

Retrieved on: 
Jeudi, août 10, 2023
Use, Marketing, Innovation, Entera, Creativity, Landgate, Robotics, Architecture, Ecosystem, Property technology, Auction, Real estate, Property management

LOS ANGELES, Aug. 10, 2023 /PRNewswire-PRWeb/ -- PropTech Breakthrough, a leading independent market intelligence organization that evaluates and recognizes standout real estate technology companies, products and services around the globe, today announced the latest round of Real Estate Technology Innovators to win in their 2023 PropTech Breakthrough Awards program.

Key Points: 
  • LOS ANGELES, Aug. 10, 2023 /PRNewswire-PRWeb/ -- PropTech Breakthrough , a leading independent market intelligence organization that evaluates and recognizes standout real estate technology companies, products and services around the globe, today announced the latest round of Real Estate Technology Innovators to win in their 2023 PropTech Breakthrough Awards program.
  • The mission of the annual PropTech Breakthrough Awards program is to conduct the industry's most comprehensive analysis and evaluation of the top technology companies, solutions and products in the real estate technology industry today.
  • We set out to recognize those leading the charge in this transformative new era," said Bryan Vaughn, Managing Director of PropTech Breakthrough Awards.
  • "From smart buildings to AI, construction, real estate finance, and even advances in architecture, the breakthrough winners in our third annual program represent excellence, creativity, hard work and success in the field of real estate technology."