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OPKO Health and Entera Bio Expand Partnership to Advance First-in-Class Oral Long Acting PTH Tablet for Patients with Hypoparathyroidism
This is the third program that successfully combines Entera’s oral peptide N-Tab® platform with OPKO’s advanced protein chemistry capabilities The companies
About this update from Opko Health, Inc.
[{"type":"text","content":"This is the third program that successfully combines Entera’s oral peptide N-Tab® platform with OPKO’s advanced protein chemistry capabilities The companies have accelerated this program and aim to file an investigational new drug (IND) application in late 2026 Injectable and oral oxyntomodulin (dual GLP-1/glucagon analog) for metabolic and fibrotic disorders advancing with initial Phase 1 data from injectable oxyntomodulin (OXM) expected in late 2026; oral OXM to enter clinic thereafter Industry veteran Steve Rubin joins Entera’s board MIAMI and TEL AVIV, Israel, Feb. 04, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK), through its wholly owned subsidiary, OPKO Biologics (OPKO), and Entera Bio Ltd. (NASDAQ: ENTX) (Entera or the Company), a leader in the development of oral peptide and protein replacement therapies, today announced the expansion of their 2025 Collaboration and License Agreement to advance the first oral long-acting PTH analog (LA-PTH) as a once-daily tablet for patients with hypoparathyroidism. The additional program combines OPKO's proprietary long-acting PTH variants with Entera's proprietary N-Tab® technology. Following favorable pharmacodynamic and pharmacokinetic (PK/PD) data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an IND application with the U.S. Food and Drug Administration (FDA) in late 2026. Under the expanded collaboration agreement, OPKO and Entera will each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program and will each be responsible for 50% of the program's development costs. The companies maintain their previously announced 60%/40% (OPKO/Entera) ownership structure and cost-sharing arrangement for the oral OXM program for metabolic and fibrotic disorders. Additionally, the companies announced that Steve Rubin, Executive Vice President of Administration and director at OPKO, has joined the board of directors of Entera as Gerry Ostrov steps down from the board. Mr. Rubin joins Entera with three decades of experience in corporate governance and strategic oversight of drug development across multiple public biotechnology companies. \"The partnership that our team has forged with OPKO since late 2023 has been very synergistic. Oral OXM and oral GLP-2 have both demonstrated robust PK profiles and bi...