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 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
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
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
"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 bioavailability. Furthermore, preclinical data of oral LA-PTH suggests that this program holds the potential to transform the hypoparathyroidism landscape,” said
Hypoparathyroidism is a heterogeneous, rare endocrine disorder that leads to abnormally low calcium and high phosphorus levels in the blood and requires chronic PTH replacement therapy. Today, the only approved PTH replacement treatment, YORVIPATH® developed by
As part of OPKO’s and Entera’s collaboration, the companies are advancing into the clinic the first oral dual agonist GLP-1/glucagon peptide for patients with obesity, metabolic and fibrotic disorders. Since
About
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP-1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on
About OPKO
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release, including those regarding our prospects, plans, financial position, business strategy and expected financial and operational results, may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s and OPKO’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, whether by Entera, OPKO or their respective collaboration and laboratory partners; impacts to research and development or clinical activities that Entera or OPKO may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing our product candidates; the parties’ reliance on third parties to conduct clinical trials; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt-out, and strategic collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in
Company Contact:
Ms.
Chief Executive Officer
miranda@enterabio.com
OPKO Health
Alliance Advisors IR
ybriggs@allianceadvisors.com
or
bvoss@allianceadvisors.com
Entera Bio
