Entera Bio Ltd., a leader in the development of orally delivered large molecule therapeutics, announced recently that the U.S. Food and Drug Administration (FDA) has reviewed the company’s Investigational New Drug (IND) application for EB613, orally delivered human parathyroid hormone (1-34), or PTH and informed Entera that it may proceed with its initial U.S. clinical trial. EB613 is positioned as the first potential drug candidate that could provide a patient-friendly, once-daily, oral, bone-building (anabolic) treatment for osteoporosis patients.

“There is a clear and compelling need for an oral PTH treatment that builds bone in patients with osteoporosis. With enrollment in the ongoing Phase 2 clinical trial of EB613 complete, we look forward to reporting the final biomarker data in the first quarter of 2021 and the final bone mineral density data from this trial in the second quarter of 2021,” stated Arthur Santora, MD, PhD Chief Medical Officer of Entera. “Subject to the successful completion of the EB613 Phase 2 clinical trial, we intend to enter into a dialogue with the FDA to discuss the design of a pivotal Phase 3 clinical trial in order to ensure we meet all of the FDA’s requirements for potential approval under the 505 (b)(2) regulatory pathway.”

As part of the IND filing, Entera provided to the FDA data from a total of more than 70 subjects from two previously completed Phase 1 trials conducted in Israel during the development of EB613 and from an additional 35 subjects that participated in Entera’s EB612 studies in Israel, including a 4-month hypoparathyroidism trial. EB613 is currently in a dose-ranging, placebo-controlled study in postmenopausal female subjects with osteoporosis, or low BMD, that is being conducted at four leading medical centres in Israel.

EB613 is an orally delivered human parathyroid hormone (1-34), or PTH, drug candidate positioned as the first potential once-daily, oral, bone-building (anabolic) treatment for osteoporosis patients. Teriparatide for injection (marketed under the brand name Forteo) was approved in the U.S. in 2002 for the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture and is taken daily via a subcutaneous injection. Entera Bio completed enrollment of a 6-month phase 2 study in postmenopausal women with osteoporosis, or low BMD evaluating multiple doses of oral EB613 (and placebo) on BMD of the spine and proximal femur (hip), and anticipates reporting top-line BMD efficacy and safety results for the trial in the second quarter of 2021.

Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, which leads to greater fragility and an increase in fracture risk. Osteoporosis is also a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. The debilitating effects of osteoporosis have substantial costs and osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025. The National Osteoporosis Foundation (NOF) has estimated that eight million women already have osteoporosis, and another approximately 44 million may have low bone mass placing them at increased risk for osteoporosis. In US women 55 years of age and older, the hospitalization burden of osteoporotic fractures and population facility-related hospital cost is greater than that of myocardial infarction, stroke, or breast cancer.