Business
Entera Bio Presents Positive Phase 2 6-Month Bone Mineral Density Data for Oral PTH Formulation at Late Breaker ASBMR Conference Session
Increases in lumbar spine, femoral neck and total hip BMD demonstrated with EB613 Linear Dose Responses Seen in Biomarker and Bone Mineral Density Data
About this update from Entera Bio Ltd.
[{"type":"text","content":"Increases in lumbar spine, femoral neck and total hip BMD demonstrated with EB613 Linear Dose Responses Seen in Biomarker and Bone Mineral Density Data Pivotal Phase 3 registration study expected to commence 2022 BOSTON and JERUSALEM, Oct. 06, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, presented the 6-month bone mineral density (BMD) data from its completed Phase 2 clinical trial of EB613, an oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis. The Late Breaking Presentation “A Six-month Phase 2 Study of Oral PTH in Postmenopausal Women with Low Bone Mass – 6 Month Bone Mineral Density (BMD) Results” was selected for a prestigious oral presentation, given by Entera’s Chief Medical Officer, Dr. Arthur Santora. The oral presentation was given at 12:15 PM PDT at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in San Diego on Monday, October 4, 2021. Many scientific leaders in the field of Osteoporosis expressed great excitement with the data and the possibility of an oral osteoanabolic (bone building) agent which elderly osteoporosis patients would be willing to take. This Phase 2 Dose Ranging study in Osteoporosis showed clinically significant changes in increases in BMD at the spine, femoral neck, and total hip. These BMD changes were associated with an increase in P1NP and a decrease in the serum CTX biomarker. A difference between the increase in P1NP, a marker of bone formation and the change in CTX, a marker of bone resorption, usually indicates an increase in bone mass, and is sometimes referred to as an “anabolic window.” Key secondary endpoints for the trial included changes in lumbar spine, femoral neck and total hip BMD, the bone markers P1NP, osteocalcin and serum CTX after 6 months of treatment. The most important secondary objective in the study was the demonstration of a statistically significant increase in BMD of the lumbar spine. Patients receiving 2.5 mg oral PTH for 6 months had a placebo-adjusted increase of 3.78% in lumbar spine (LS) BMD (p","length":2720,"tagName":"div"}]