ENTERA BIO LTD. Entera Bio Ltd. announced it has concluded its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on EB613, its oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis and defined the path for Phase 3 development of EB613, confirming that a fracture study will not be necessary and that lumbar spine BMD at 12 months can be the primary endpoint. The meeting followed completion of its Phase 2 clinical trial, which met its endpoints, including increases in lumbar spine, femoral, neck and hip bone mineral density (BMD) versus placebo after six months of treatment, and demonstrated a safety profile consistent with subcutaneous PTH (1-34) (teriparatide injection) (Forteo®). Based on FDA feedback at the meeting, Entera is currently proceeding with its plans for a Phase 3 registration study of EB613 this year.
The FDA confirmed that a comparison of Entera's EB613 dosed at 2.5 mg versus subcutaneous PTH (1-34) with a lumbar spine BMD increase at 12 months as the primary endpoint for the trial would be acceptable. The company may rely on marketed drugs as part of a 505(b)(2) regulatory approval pathway. The FDA's 505(b)(2) new drug application (NDA) pathway helps avoid unnecessary duplication of studies already performed on previously approved drugs.
If approved, EB613 would be the first oral anabolic agent for the treatment of osteoporosis. Currently, more than 90% of osteoporosis patients are treated with oral agents. Osteoporosis is a silent disease, which causes little or no pain to the patient until an event occurs, and a bone is fractured.
For this reason, many elderly patients are unwilling to take an injectable medication. If EB613 is approved, Entera believes that it could dramatically expand the number of patients who are treated with anabolic bone building therapies, as well as replacing the medication of some patients already on an injectable therapy. With more than 200 million osteoporosis patients worldwide, of which the vast majority are not treated, osteoporosis represents a market with incredible potential for growth.
