Business
Entera Bio Reports Third Quarter 2021 Financial Results
‒ Two Presentations at ASBMR, including Late Breaker, on Phase 2 EB613 Clinical Trial Results in Osteoporosis ‒ ‒ Study Sets Stage for Phase 3 registrational
About this update from Entera Bio Ltd.
[{"type":"text","content":"‒ Two Presentations at ASBMR, including Late Breaker, on Phase 2 EB613 Clinical Trial Results in Osteoporosis ‒ ‒ Study Sets Stage for Phase 3 registrational trial in 2022 ‒ BOSTON and JERUSALEM, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced financial and operating results for the third quarter ended September 30, 2021. Third Quarter 2021 and Recent Highlights Phase 2 EB613 (oral PTH 1-34) clinical data selected for a late breaker oral presentation at the American Society for Bone and Mineral Research Annual Meeting (ASBMR) demonstrated clinically significant increases in bone mineral density (BMD) at the spine, femoral neck, and total hip in patients with osteoporosis. In the six-month study, EB613 performed comparably to reported results of injectable PTH 1-34 (Forteo®) for increase in lumbar spine BMD and also demonstrated significant increases of BMD at the femoral neck and hip.The trial demonstrated favorable changes in two key biomarkers, an increase in P1NP, the primary study endpoint and a marker of bone formation, and a decrease in serum CTX, a biomarker of bone resorption.EB613’s safety profile in the study was consistent with injectable PTH 1-34.Entera has scheduled an End-of-Phase-2 Meeting with the FDA to review the company’s proposed single Phase 3 protocol under the 505(b)(2) pathway to demonstrate non-inferiority to Forteo in BMD increase. Key Study Describing Entera’s Oral Delivery Platform for Biologic Drugs Published in the Journal of Pharmaceutics X: Researchers at Entera and at the University of East Anglia in the UK published results from preclinical in vivo studies that demonstrated the efficiency of Entera’s platform technology to consistently deliver large molecule biologic drugs into the bloodstream at appropriate levels through oral administration. The study describes the company’s innovative dual mechanism of action approach to oral drug delivery of large molecules aimed at protecting biomolecules from breakdown in the gastrointestinal tract and facilitating their absorption into the bloodstream. Entera is utilizing the platform with EB613 and several other molecules now in development by Entera in collaboration with pharmaceutical companies. Robust Balance Sheet: Entera strengthened its ba...