OPKO Health and Entera Bio Expand Partnership to Advance First-in-Class Oral Long Acting PTH Tablet for Patients with Hypoparathyroidism

Core Viewpoint - OPKO Health and Entera Bio are expanding their collaboration to develop innovative oral peptide therapies, including a long-acting PTH analog for hypoparathyroidism and an oral oxyntomodulin for metabolic disorders, with IND applications expected in late 2026 [3][4][5]. Group 1: Collaboration and Development Programs - The collaboration between OPKO and Entera aims to advance the first oral long-acting PTH analog (LA-PTH) as a once-daily tablet for hypoparathyroidism, with an IND application planned for late 2026 [3][4]. - The companies are also developing an injectable and oral oxyntomodulin (OXM) for metabolic and fibrotic disorders, with initial Phase 1 data from the injectable form expected in late 2026 [1][8]. - Under the expanded collaboration agreement, both companies will hold a 50% ownership interest in the LA-PTH program and share development costs equally, while maintaining a 60%/40% ownership structure for the oral OXM program [5]. Group 2: Key Personnel Changes - Steve Rubin, an industry veteran with extensive experience in corporate governance and drug development, has joined Entera's board of directors, replacing Gerry Ostrov [2][6]. Group 3: Clinical Data and Market Potential - Preclinical data for the oral LA-PTH program suggests it could transform treatment for hypoparathyroidism, which currently relies on daily injections of the only approved PTH replacement therapy [7]. - Entera's previous clinical data for its EB612 program indicated significant reductions in calcium supplement use and maintenance of serum calcium levels, although the regimen required multiple daily doses [7]. - The oral oxyntomodulin is positioned as a dual GLP-1/glucagon agonist with potential benefits for obesity and metabolic disorders, with no approved dual agonists currently available [8].