Entera Bio Announces New Data Supporting Further Development of a Proprietary First-in-Class Oral, Long-Acting PTH Tablet for Patients with Hypoparathyroidism (EB612 Program) - Entera Bio (NASDAQ:ENTX

Core Insights - Entera Bio Ltd. announced new in vivo pharmacokinetic and pharmacodynamic data supporting the development of a long-acting parathyroid hormone (PTH) analog for hypoparathyroidism, aiming to create the first once-daily tablet treatment [1][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab® platform to address significant unmet medical needs [7] - The company is advancing multiple programs, including EB612 for hypoparathyroidism and EB613 for osteoporosis, with a goal of transforming the standard of care through oral formulations [7] Product Development - The EB612 program aims to provide a single, once-daily PTH tablet, addressing the dosing burden associated with current treatments that require daily or weekly injections [3][4] - Recent preclinical findings showed that the proprietary PTH analog achieved a significantly longer plasma half-life and sustained calcium elevation for over three days, compared to unmodified PTH(1-34) controls, which did not elicit a calcium response [1][9] Clinical Evidence - A previous Phase 2 study demonstrated a 42% reduction in median calcium supplement use while maintaining serum calcium levels above the lower limit for hypoparathyroidism patients, although it involved a four-times-a-day dosing regimen [3] - The recent minipig study confirmed the pharmacokinetic and pharmacodynamic profile of the new PTH analog, supporting its potential for once-daily dosing [5][9] Future Plans - Entera plans to present the new data at an upcoming medical conference, indicating ongoing commitment to advancing its clinical programs [6]