JERUSALEM, July 26, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced the formation of its Clinical and Scientific Advisory Board (CSAB), consisting of world class experts in bone diseases, endocrinology, and metabolic disorders. In addition, the Company announced today that it will be presenting new data from its 6-month Oral PTH (EB613) Phase 2 Study in postmenopausal women with low bone mass, or osteoporosis at the 2022 Annual Meeting of the American Society for Bone and Mineral Research (ASBMR), which will take place in Austin, Texas from September 9-12, 2022.
The inaugural members of Entera’s CSAB include:
Professor John P. Bilezikian: Vice-Chair, Department of Medicine for International Research and Education; Chief, Emeritus, of the Division of Endocrinology; Director, Emeritus, of the Metabolic Bone Diseases Program at Columbia University Medical Center
Professor Maria Luisa Brandi: Professor of Endocrinology, FIRMO Foundation, Florence, Italy
Professor Bart Clarke: Professor of Medicine and Consultant, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic
Professor Felicia Cosman: Professor of Medicine, Emerita, Columbia University College of Physicians and Surgeons, Division of Endocrinology; Co-Editor in Chief of the journal Osteoporosis International
Professor William Fraser: Professor of Medicine and Deputy Head of Norwich Medical School at the University of East Anglia and Consultant in Metabolic Medicine at the Norfolk and Norwich University Hospital, UK
Dr. Roger Garceau: Former Chief Medical Officer and EVP at NPS Pharmaceuticals and Shire plc (Natpara®); with previous senior management roles at Sanofi Aventis and Pharmacia
Professor Sophia Ish-Shalom: Vice President of the Israeli Foundation for Osteoporosis and Bone Diseases (IFOB), Endocrine Clinic Elisha Hospital; prior Head of Bone and Mineral Metabolism Unit, Rambam Health Care Campus , Haifa Israel
Professor Socrates Papapoulos: Emeritus Professor in Diseases of Bone & Mineral Metabolism, Advisor Center for Bone Quality, Leiden University Medical Center, The Netherlands
“We are honored to be working with this distinguished group of thought leaders and appreciate their support and guidance of our clinical development strategy,” said Miranda Toledano, Entera’s Chief Executive Officer. “Their extensive clinical and scientific experience in late-stage clinical trials have been invaluable to the advancement of our core osteoporosis and hypoparathyroidism programs.” Arthur Santora, M.D., Ph.D., Chief Medical Officer of Entera said, “We have been working collaboratively to advance Entera’s proprietary oral pipeline and the support of our CSAB provides phenomenal validation to our efforts. We look forward to benefitting from their collective expertise as we continue to move toward our mission of delivering oral therapeutic options to patients high unmet medical needs.”
The title of the abstract accepted for presentation at the ASBMR 2022 National Meeting and current schedule for presentation follows:
Abstract Title: A Six-month Phase 2 Study or Oral PTH (EBP05) in Postmenopausal Women with Low Bone Mass – Dose Proportional Absorption and Effect on Lumbar Spine BMD
Presentation Type: Poster PresentationSession: Poster Session II & Poster ToursSession Date/Time: Sunday, September 11, 2022 from 1:00 pm – 3:00 pm Presentation Time: 1:00 pm – 3:00 pm
Location: ASBMR Discovery Hall
About EB613 (a.k.a. EBP05)
Parathyroid hormone (PTH) is an 84-amino acid hormone and the primary regulator of calcium and phosphate metabolism in bone and kidney. EB613 is an oral formulation of synthetic hPTH (1-34), (teriparatide), a peptide consisting of the first 34 amino acids of PTH which represent the functional region. Subcutaneous Forteo® (teriparatide injection) has been the leading anabolic treatment of osteoporosis since 2002. EB613 utilizes Entera’s oral drug delivery platform which promotes enteric absorption and stabilizes teriparatide in the gastrointestinal tract. Entera’s Oral PTH formulations have been administered collectively to a total of 225 subjects in two Phase 1 studies and 3 phase 2 studies (including 35 in 2 phase 2 hypoparathyroidism studies). The most recent study was a dose ranging Phase 2 study in postmenopausal women with low bone mass. This study met primary and key secondary endpoints and was presented in a late-breaker oral presentation at the ASBMR 2021 conference. For the primary efficacy endpoint: a statistically significant increase in P1NP (a bone formation marker) at 3 months was achieved. A significant dose response was observed for 0.5, 1.0, 1.5 and 2.5 mg oral PTH doses on P1NP, Osteocalcin and bone mineral density (BMD). Subjects receiving the 2.5 mg dose of EB613 showed significant increases in dose-related BMD at the lumbar spine, total hip, and femoral neck at 6 months. Subjects receiving the 2.5 mg dose of EB613 daily for 6 months had a significant placebo adjusted increase of 3.78% in lumbar spine BMD (p