Entera Bio Ltd. announced that EB612, an oral PTH for the treatment of hypoparathyroidism, successfully met the primary and secondary endpoints in a Phase 2a clinical trial. Hypoparathyroidism, for which EB612 was granted orphan drug designation in the U.S. and Europe, is a rare condition in which a person produces an abnormally low level of PTH, causing a heavy disease burden due to its impact on a patient’s cardiovascular, neurologic, renal, and skeletal systems. There is a clear unmet medical need for a safe and effective treatment for the estimated 60,000 insured hypoparathyroidism patients in the U.S., as Natpara®, the one drug currently approved by the FDA for this indication was recalled in 2019 and has only recently been reintroduced to a limited number of those patients due to supply issues. Furthermore, this drug is likely to be used in only the most severe patients due to its potential risk of bone cancer in animal studies.