Entera Bio Reports Rapid Pharmacodynamic Response And Consistent Pharmacokinetic Data For Its First-In-Class Oral PTH(1-34) Mini Tablets At The ASBMR 2023 Annual Meeting

Author: Benzinga Newsdesk | October 16, 2023 08:20am

Entera Bio Ltd. (NASDAQ:ENTX), ("Entera" or the "Company") a leader in the development of orally delivered peptides and therapeutic proteins, presented 2 posters at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13-16, 2023 in Vancouver, BC, Canada. Both posters will be available on the Company's website, www.enterabio.com.

 

"Entera's ability to consistently deliver our oral PTH(1-34) peptide in a simple mini tablet format with reproduceable, dose dependent pharmacokinetics and rapid biological responses irrespective of gender, age, and health status is testament to the robustness of our oral peptide platform. This work also builds the foundation for our oral PTH(1-34) tablets to potentially treat diverse patient populations including younger men and women athletes at risk of stress fractures," said Miranda Toledano, Chief Executive Officer of Entera.

The lead drug candidate of Entera's EBP05 formulation, EB613 is currently being developed as the first once-daily oral anabolic therapy for the treatment of osteoporosis. In a 6-month, 161-patient, placebo-controlled Phase 2 study, EB613 produced rapid dose-proportional changes in biochemical markers and increased Bone Mineral Density (BMD) in postmenopausal women with low BMD osteoporosis.

Abstract Title:  First Oral PTH(1-34) Tablet Treatment for Osteoporosis Demonstrates Rapid Pharmacodynamic Effect on Plasma Levels of Endogenous PTH(1-84)

A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera's oral peptide delivery platform is ongoing. One of the first objectives of this study is to rapidly evaluate the pharmacodynamic (PD) effects of Entera's oral PTH(1-34) tablets. This analysis relates to Entera's lead formulation. Additional data on new formulations will be released later in 2023.

An increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1-84). Thus, a reduction in plasma PTH(1-84) should provide an early indication of the systemic exposure and pharmacologic activity of Entera's oral PTH(1-34) tablets. In the study, the mean percentage of endogenous plasma PTH (1-84) 120 minutes after dosing was 59.2%, 54.3%, and 52.3% for EB613 1.5 mg, 2.5 mg and Forteo®, respectively; and showed consistent effects across other early PD markers such as serum calcium, phosphorus, and 1,25-dihydroxyvitamin D.

"EB613 oral tablets (1.5 mg and 2.5 mg doses) rapidly decreased plasma concentrations of PTH(1-84) in all subjects, in a dose proportional manner. The results provide early proof of the systemic exposure and pharmacological activity to Entera's orally administered PTH(1-34) tablets. The ability to rapidly evaluate PD effects as early markers of therapeutic response is crucial to assessing a drug's activity in osteoporosis patients and potentially optimize their management. In contrast, response with conventional PD markers of bone metabolism may take several months. Thus, we plan to continue to measure PTH(1-84) responses in further clinical development of EB613," said Art Santora, MD, Entera's Chief Medical Officer.

Abstract Title:  Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men.

This retrospective analysis compares the pharmacokinetic profile of EBP05 in healthy young males versus female patients of menopausal age with hypoparathyroidism.

A single administration of the same dose, 2.25 mg oral PTH (1-34), in healthy young men (22 years, range 21-26) and women of postmenopausal age (62 years, range 49 -63) resulted in a median Cmax of 425 pg/ml vs 521 pg/ml, and a median AUC of 157 pg*hour/ml vs 158 pg*hour/ml respectively.

"The data showed a consistent PK profile following administration of oral EBP05 tablets in both young men and women of menopausal age. These similar profiles indicate that similar doses of our oral PTH tablets may be used across these different populations," said Gregory Burshtein PhD, Entera's Head of Research and Development.

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