UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16

OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of November 2018

Commission file number: 001-38556

ENTERA BIO LTD.

(Exact Name of Registrant as Specified in Its Charter)

Kiryat Hadassah
Minrav Building – Fifth Floor

Jerusalem, Israel
(Address of principal executive office)

_____________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F S           Form 40-F £

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): £

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): £

 

This report on Form 6-K of the registrant consists of a press release issued by the registrant on November 8, 2018, attached hereto as an exhibit and incorporated by reference herein.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: November 8, 2018

 

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Entera Bio Reports Positive Results from Part 1 of a Phase 2 PK/PD Study of

Oral PTH (1-34) in Patients with Hypoparathyroidism

 

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Demonstrates positive results in three metabolic parameters in patients with

hypoparathyroidism treated with Oral PTH (1-34)

 

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Reports a significant decrease in 24-hour urinary calcium in hypoparathyroid patients

 treated with Oral PTH (1-34)

 

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Jerusalem, Israel – November 8, 2018 – Entera Bio Ltd. (Nasdaq: ENTX) announced today that it has received positive results from the first part of its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its oral parathyroid hormone (PTH) drug [“Oral PTH (1-34)”].

 

 

 

 

 

PK/PD Study design and results

 

Part 1 of this Phase 2 trial in patients with hypoparathyroidism was designed to evaluate the PK and PD profiles of Oral PTH (1-34) and injectable PTH (1-84), Natpara^®*.

 

In this partial crossover study, ten patients completed two three-day in-patient visits. Throughout each of these three-day visits, patients remained on their current standard medications. On the first day of each visit (baseline) patients received no additional treatments. On day two, patients were randomized to receive one of three treatments: Oral PTH (1-34) twice a day (BID), Oral PTH (1-34) four time a day (QID), or injectable PTH (1-84) (Natpara^®*) once a day (QD). On day three, patients did not receive any additional treatments.  In the second three-day visit, patients were again randomized on day two to receive one of the treatment regimens they had not received previously.  Throughout the three-day visits, patients were continuously monitored clinically. Blood samples were taken to measure PTH, calcium, phosphate, and active vitamin D (1,25-(OH)₂). Twenty-four-hour urine samples were collected to measure urinary calcium.

 

PTH has several well-known physiological effects. It increases serum calcium, decreases serum phosphate and increases active vitamin D synthesis.

 

Results from the PK/PD study of Oral PTH (1-34) QID treatment include:

 

1.

The serum calcium increase averaged approximately 0.3 mg/dL over baseline, and this increase was maintained over a 24-hour period;

 

2.

Serum phosphate decreased an average of 0.5 mg/dL below baseline and this decrease was maintained over a 24-hour period;

 

3.

Average levels of serum active vitamin D increased by approximately 90% on the day of treatment as compared to baseline; and

 

4.

Average levels of 24-hour urinary calcium decreased by approximately 30% on the day of treatment as compared to baseline.

 

An initial analysis of the Part 1 data suggests that the QID regimen provided a greater effect on all of the parameters measured as compared to the BID regimen. The concentration of PTH (1-34) in blood after administration of Oral PTH (1-34) in the current study was sufficient to produce the observed pharmacodynamic effects and did not induce hypercalcemia. No serious adverse events were reported in the study.

 

The second and final part of this PK/PD study will evaluate a three times per day (TID) treatment regimen with a high and low dose of Oral PTH (1-34), as well as Natpara. The results from the completed Phase 2 PK/PD trial will provide input for the design of our anticipated pivotal clinical trials. Details of the complete data set of this PK/PD study will be presented at scientific meetings and in publications in 2019.

 

About Hypoparathyroidism

 

Hypoparathyroidism is a rare condition in which the body produces insufficient amounts of PTH. Individuals with a deficiency of PTH typically exhibit abnormally low levels of calcium in the blood, or hypocalcemia, and high levels of phosphate in the blood, or hyperphosphatemia. Hypoparathyroidism is estimated to affect approximately 58,000 individuals in the United States. Historically, the treatments for hypoparathyroidism have been calcium supplements, vitamin D supplements and phosphate binders, the chronic use of which may result in serious side effects which can result in significant costs to the healthcare system. Natpara®, a once-daily injectable form of PTH, has been approved by the FDA and EMA for the treatment of hypocalcemia in patients with hypoparathyroidism.

 

 

 

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, Oral PTH (1-34), for treatment of hypoparathyroidism and osteoporosis.

 

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 http://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.

 

Contact:
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
bob@lifesciadvisors.com

 

 

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