ENTX Entera Bio Ltd

Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long-acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N-Tab™ technology. The program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity, metabolic and fibrotic disorders. OXM is a naturally occurring peptide hormone found in the small intestine that acts to suppress appetite and induce weight loss.

Entera and OPKO have completed in vivo proof-of-concept PK/PD studies in rodent and pig models. The studies’ objectives were met with oral OXM exhibiting significant systemic exposure following a single dose in both models. Furthermore, a favorable PK profile and bioavailability were shown with oral OXM. In the pig model, oral OXM achieved high plasma concentrations with prolonged systemic exposure, which is consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog.

To assess the pharmacologic effect of oral OXM, a glucose tolerance test was performed in rats. Oral OXM showed a statistically significant reduction in plasma glucose levels post-glucose administration compared with placebo. Entera and OPKO plan to present these data at an upcoming clinical conference.

“We are very pleased with the progress we are making in our collaboration with OPKO. These bioavailability and pharmacological data support continuing toward IND-enabling efforts for the program,” said Miranda Toledano, Entera Chief Executive Officer.

OPKO previously reported that weekly injections of pegylated OXM demonstrated significant weight loss and reduction in HbA1, triglyceride and cholesterol levels in 113 obese and diabetic patients in a Phase 2B study. The OXM agonist peptide has since been modified to maintain its long-acting profile while increasing its potential potency. Currently, there are no approved OXM agonists available, and those in development by others are small molecules or require subcutaneous injections.

About Entera Bio

Entera is a clinical-stage company focused on developing oral peptide or 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 a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. 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 (BMD) endpoints. Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint, which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH (1-34) tablet peptide replacement therapy for hypoparathyroidism. In collaboration with OPKO Health, Entera is also developing the first oral oxyntomodulin, a dual targeted GLP-1/glucagon peptide, in tablet form for the treatment of obesity; and the first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome. For more information, visit www.enterabio.com or follow us on LinkedIn, X (formerly Twitter), Facebook and Instagram.

About OPKO Health

OPKO Health 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 its novel and proprietary technologies. For more information, visit www.opko.com.

Cautionary Statement Regarding Forward Looking StatementsVarious 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 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, either by Entera or its 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; Entera’s reliance on third parties to conduct its clinical trials; Entera and OPKO’s expectations regarding licensing, business transactions 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 the United States; Entera’s and OPKO’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s and OPKO’s most recent Annual Report on Form 10-K filed with the SEC, as well as the companies’ subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward-looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and Entera and OPKO undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Contacts:

Entera Bio
Miranda Toledano
Chief Executive Officer
miranda@enterabio.com

OPKO Health
LHA Investor Relations
Yvonne Briggs, 310-691-7100
ybriggs@lhai.com 

or 

Bruce Voss, 310-691-7100 
bvoss@lhai.com