Opko Health and Entera Bio Expand Partnership to Develop First Oral Long-Acting PTH Therapy for Hypoparathyroidism
核心洞察
Opko Health (搜索) and Entera Bio expanded their partnership on February 4 to advance the first oral long-acting PTH analog treatment for hypoparathyroidism (搜索) patients as a once-daily tablet.
The companies established equal 50% ownership and cost-sharing for the LA-PTH (搜索) hypoparathyroidism (搜索) program while accelerating development timelines.
An Investigational New Drug application with the FDA is expected to be filed in late 2026 for this novel oral peptide therapy.
Opko Health (搜索) Inc. (NASDAQ:OPK) announced on February 4 an expanded partnership with Entera Bio Ltd. to advance the development of the first oral long-acting parathyroid hormone (PTH) analog treatment for patients with hypoparathyroidism (搜索). The collaboration aims to deliver this breakthrough therapy as a once-daily tablet, representing a significant advancement in treatment options for this rare endocrine disorder.
Partnership Structure and Development Timeline
Under the expanded agreement, both companies will hold equal 50% pro rata ownership interest in the LA-PTH (搜索) hypoparathyroidism (搜索) program, with each partner responsible for 50% of the development costs. This represents a shift from their previous arrangements and demonstrates both companies' commitment to advancing this novel therapeutic approach.
The partnership has also accelerated development timelines, with the companies expecting to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026. This timeline positions the oral PTH therapy for potential clinical trials in the coming years.
Broader Collaboration Portfolio
The companies maintain their previously established ownership structure for the oral OXM (搜索) program targeting metabolic and fibrotic disorders, with Opko Health (搜索) holding 60% ownership and Entera Bio maintaining 40%. This demonstrates the strategic nature of their ongoing collaboration across multiple therapeutic areas.
Company Profiles
Opko Health (搜索) Inc. operates as a biopharmaceutical and diagnostics company providing healthcare services through its Diagnostics and Pharmaceuticals segments. Entera Bio Ltd. specializes in developing oral peptide and protein replacement therapies, bringing specialized expertise in oral delivery technologies for traditionally injectable medications.
The development of an oral long-acting PTH analog represents a potential paradigm shift for hypoparathyroidism (搜索) treatment, offering patients a convenient once-daily oral option compared to current therapeutic approaches.