Entera Bio Ltd.

Entera is a clinical stage company focused on developing oral tablet forms of peptide or protein replacement therapies for chronic medical conditions. The company aims to address underserved conditions where oral administration of protein therapy could significantly change treatment. Most protein therapies are currently given through frequent intravenous, subcutaneous, or intramuscular injections, which can be challenging for patients with chronic diseases. Entera's pipeline includes oral peptides targeting PTH(1-34), GLP-1/Glucagon, and GLP-2. The company uses its N-Tab® platform, designed to stabilize large (4kD+) hydrophilic peptides in the gastrointestinal tract and promote their absorption into the bloodstream. The most advanced product candidate is EB613 (oral teriparatide, or oral PTH[1-34]), which is being developed as the first oral, osteoanabolic (bone building) tablet treatment for osteoporosis. EB613 is being developed under a 505(b)(2) application, referencing Forteo® (teriparatide SC injection, Eli Lilly). Forteo® was initially approved by the FDA in 2002 for postmenopausal women with osteoporosis at high risk of fracture, and later for men with osteoporosis and osteoporosis associated with sustained systemic glucocorticoid therapy. Forteo® has been in clinical use for over 20 years. Osteoporosis is a chronic disorder where bone resorption exceeds formation, leading to decreased bone strength and increased fracture susceptibility. It causes over two million fractures annually in the United States. After age 50, one in three women and one in five men will experience an osteoporosis-related fracture. Studies indicate that up to 20-24% of hip fracture patients die within one year.