Entera Bio Ltd. (Nasdaq: ENTX) announced today that it has received positive results from the first part of its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its oral parathyroid hormone (PTH) drug [“Oral PTH (1-34)”], demonstrating positive results in three metabolic parameters in patients.
“The results from Part 1 of the PK/PD study in patients with hypoparathyroidism have confirmed that Oral PTH (1-34) activates biological pathways that PTH is known to regulate. This study builds on and supports our previous PK results in more than 100 subjects and confirms that Oral PTH (1-34) is effectively delivered into the bloodstream,” stated Dr. Phillip Schwartz, Chief Executive Officer of Entera Bio. “In addition to positively impacting the levels of serum calcium, phosphate, and active vitamin D (1,25-dihydroxy vitamin D), we also observed a significant decrease in 24-hour urinary calcium levels in hypoparathyroid patients treated for one day with Oral PTH (1-34). These results further support our belief that the administration of Oral PTH (1-34) multiple times per day may improve hypercalciuria in hypoparathyroid patients.”
Hypoparathyroidism is a rare condition in which the body produces insufficient amounts of PTH. Individuals with a deficiency of PTH typically exhibit abnormally low levels of calcium in the blood, or hypocalcemia, and high levels of phosphate in the blood, or hyperphosphatemia. Hypoparathyroidism is estimated to affect approximately 58,000 individuals in the United States. Historically, the treatments for hypoparathyroidism have been calcium supplements, vitamin D supplements and phosphate binders, the chronic use of which may result in serious side effects which can result in significant costs to the healthcare system. Natpara®, a once-daily injectable form of PTH, has been approved by the FDA and EMA for the treatment of hypocalcemia in patients with hypoparathyroidism.
*Natpara® is the brand name used in United States for Natpar® which is sold by Shire Plc. in Europe. Natpar® was used in this Phase 2 clinical trial.
About Entera Bio Ltd.
Entera Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in orphan indications and other areas with significant unmet medical needs. The Company is initially applying its technology to develop an oral formulation of parathyroid hormone, Oral PTH (1-34), for treatment of hypoparathyroidism and osteoporosis.