Entera Bio Completes Part 1 of a Phase 2 PK/PD Study in Hypoparathyroidism Patients

A second and final part of the study will evaluate selected dose regimens chosen based on part 1

JERUSALEM, Aug. 01, 2018 (GLOBE NEWSWIRE) — Entera Bio Ltd. (Nasdaq: ENTX), announced today that it has completed the first part of the PK/PD study in hypoparathyroidism patients with its oral parathyroid hormone (PTH) drug, EB612, conducted at the Hadassah University Medical Center. Patients received various dose regimens of EB612 with or without a 100 microgram injection of Natpar administered on a separate visit. No serious adverse events were reported.

“We are pleased to have completed the first part of the Phase 2 study for hypoparathyroidism on track with our timeline and look forward to announcing the results in the coming months,” stated Dr. Phillip Schwartz, CEO of Entera Bio. “Treatment for hypoparathyroidism has made significant advancements over the past few years with the introduction of PTH. However, the current delivery method used for PTH requires daily injections. We believe an oral form of PTH would be significantly advantageous in treating this chronic condition.”

The Phase 2 trial is designed to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of oral PTH (1-34) and Natpar®, an injectable PTH (1-84), in patients with hypoparathyroidism. In part 1 of the Phase 2 study, ten patients completed two treatment visits, including three overnight stays each during which patients were administered various EB612 regimens or Natpar. Throughout the treatment visits, patients were continuously monitored and various tests were performed, including blood and urine sampling. An analysis of the part 1 data is expected within two to three months.

The second and final part of the study will evaluate selected dose regimens chosen based on the results of the trial’s first part. The results from this Phase 2 PK/PD trial will provide input for the design of our anticipated pivotal clinical trial.

About Entera Bio Ltd.
Entera Bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of orally delivered large molecule therapeutics for use in orphan indications and other areas with significant unmet medical needs. The Company is initially applying its technology to develop an oral formulation of parathyroid hormone (PTH) for hypoparathyroidism (EB612) and osteoporosis (EB613).

Forward Looking Statements
This press release contains “forward-looking statements.” Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, often signify forward-looking statements. 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. Forward-looking statements are based on information that the Company has when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. For a discussion of these and other risks that could cause such differences and that may affect the realization of forward-looking statements, please refer to the “Special Note Regarding Forward-Looking Statements” and “Risk Factors” in the Company’s Registration Statement on Form F-1 and other filings with the Securities and Exchange Commission (SEC). Investors and security holders are urged to read these documents free of charge on the SEC’s web site at https://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Bob Yedid
LifeSci Advisors, LLC

Source: Entera Bio


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