Business
Entera Bio Reports First Quarter 2022 Financial Results and Business Highlights
Registrational study design for lead clinical asset, EB613, as the first oral PTH anabolic to treat post-menopausal women at high risk of osteoporosis, is
About this update from Entera Bio Ltd.
[{"type":"text","content":"Registrational study design for lead clinical asset, EB613, as the first oral PTH anabolic to treat post-menopausal women at high risk of osteoporosis, is underwayCompany reschedules conference call and webcast to Wednesday, May 18 at 8:00 AM EDT BOSTON and JERUSALEM, May 12, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced its financial and operating results for the quarter ended March 31, 2022. First Quarter 2022 and Recent Highlights EB613 Clinical Update: Entera’s lead clinical candidate, EB613, an oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis, is progressing towards a pivotal Phase 3 clinical trial. The FDA has completed the Chemistry Manufacturing and Control (CMC) review in relation to EB613. Entera and the FDA agreed upon the production and specifications of the drug’s components and final product for the Phase 3 study. The Company looks forward to providing further updates related to its productive discussions with the Food and Drug Administration (FDA) in the near term. EB613 Analytics Study: As part of its pre-pivotal study planning, Entera completed a comprehensive market and analytics study concerning EB613 and its potential as the first oral anabolic and first oral PTH product available to post-menopausal women at high risk of osteoporosis. The study aimed at understanding treatment paradigms and quantifying the U.S. market potential of EB613 by evaluating prescriber, health plan, and managed care inputs. Key conclusions include: Osteoporosis represents a large market of over 15 million patients in the U.S., yet approximately 75% of the target population is not receiving any pharmacological treatmentDespite endocrinologists recognizing the clinical benefit of initiating anabolic treatments (such as current injectable PTH agents) for higher risk patients prior to first line bisphosphonates, their high cost and patients’ unwillingness to opt for a subcutaneous injection is limiting treatmentClinicians were receptive to EB613’s efficacy (based on Phase 2 data) as an anabolic treatment, its improved safety profile, and as an oral route of administration Payers surveyed were favorable to EB613 and characterized the value proposition as a safe, oral anabolic treatment opti...