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 September 2019
Commission file number: 001-38556
ENTERA BIO LTD.
(Exact Name of Registrant as Specified in Its Charter)
Kiryat Hadassah
Minrav Building – Fifth Floor
Minrav Building – Fifth Floor
Jerusalem, Israel
(Address of principal executive office)
(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 ☒ 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): ☐
CONTENTS
This report on Form 6-K of the registrant consists of a press release issued by the registrant on September 23, 2019, attached hereto as an exhibit and incorporated by reference herein.
Exhibit
SIGNATURES
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.
|
ENTERA BIO LTD.
(Registrant)
|
|||
|
By:
|
/s/Adam Gridley
|
||
|
Name: Adam Gridley
|
|||
|
Title: Chief Executive Officer
|
|||
Date: September 23, 2019
Exhibit 99.1
|
Entera Bio Ltd.
Adam Gridley, CEO
Tel: +972-2-532-7151
adam@enterabio.com
|
INTERNATIONAL INVESTOR RELATIONS
Bob Yedid
LifeSci Advisors
646-597-6989
bob@lifesciadvisors.com
|
Entera Bio Reports Positive Results from a Phase 2 PK/PD Study of Oral PTH (1-34) in
Patients with Hypoparathyroidism
|
•
|
Results of a Phase 2 PK/PD study of Oral PTH (1-34) in patients with hypoparathyroidism were presented at the American Society
for Bone and Mineral Research Annual Meeting
|
|
•
|
Data suggest favorable pharmacologic and pharmacokinetic profiles of Entera’s Oral PTH formulation with a flexible oral
dosing regimen vs. an injectable form of PTH
|
|
•
|
Data will inform the Phase 2b/Phase 3 clinical development strategy
|
JERUSALEM, Israel & BOSTON, Mass.
(September 23, 2019) – Entera Bio Ltd. (NASDAQ: ENTX) today announced the presentation of positive results from its pharmacokinetic (PK) and pharmacodynamic (PD) study in patients with hypoparathyroidism treated with its oral parathyroid hormone (PTH) drug [Oral hPTH(1-34)]. The results were
presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Orlando, Florida on September 22, 2019.
“Entera’s previous Phase 2 study
in hypoparathyroid patients presented in 2016 showed that four times daily (QID) dosing of oral hPTH (1-34) had a positive effect on serum calcium, a reduction in serum phosphate and a reduction in urinary calcium. The goal of this new PK/PD study
was to compare twice-daily (BID), three times daily (TID) and QID dosing regimens and dose strengths of Entera’s Oral hPTH (1-34) over a 24-hour period. The results showed that the largest changes in PD endpoints were found with QID dosing, with
moderate changes in PD endpoints generally found with BID and TID dosing. In addition, the QID dosing decreased urine calcium over 24-hours, which indicates that it may be able to reduce urinary calcium in hypoparathyroid patients with
hypercalciuria during long-term treatment,” stated Professor Sofia Ish-Shalom, a principal investigator at the Endocrine Research Center at Lin Medical Center in Haifa, Israel. “As investigators, we were pleased to see that Oral hPTH (1-34) had a
positive impact on PD parameters, an increase in serum calcium, a decrease in serum phosphate and an increase in active vitamin D (1,25-dihycroxyvitamin D) synthesis. Importantly, these data again show the ability of Entera’s oral formulation to
deliver PTH to the bloodstream at concentrations that produced the anticipated PD effect. Furthermore, this well controlled study included the highest approved dose of hPTH (1-84) (Natpar®) 100 micrograms as an active control.”
“The data from this study suggest that our Oral PTH delivered at different frequencies, and
with different doses, can be used effectively to customize the therapy of individual patients. For example, some patients with elevated urinary calcium might be well served with more frequent dosing three or four times daily, while patients who
have milder disease might be adequately served by less frequent twice-a-day dosing. We as clinicians find the severity of disease is a continuum that is best treated by custom titration calcium and each drug to each patient’s needs,” stated Dr.
Arthur Santora, Chief Medical Officer of Entera. “Both PK and PD data from this study will be very valuable in helping optimize the formulation of Oral hPTH (1-34) for hypoparathyroidism, as well as designing long-term studies of a diverse
hypoparathyroid population. Importantly, for our ongoing dose ranging study in osteoporosis that employs a single daily dose of oral hPTH (1-34) each morning, the PK profile of the morning dose of oral hPTH (1-34) from this PK/PD study further
supports our belief that the blood levels after a single daily morning dose of oral hPTH (1-34) may be sufficient to increase bone formation markers and BMD.”
PK/PD Study Design
The Phase 2 PK/PD Study was open-label, and employed a 2-period partial crossover design to evaluate the PK and PD profiles of two
doses, 0.75 mg and 2.25 mg, and three regimens (BID, TID and QID) of Oral hPTH (1-34) and included subcutaneous Natpar® [hPTH (1-84)] 100 µg once daily. The study was conducted in sixteen patients with hypoparathyroidism at the Hadassah
Clinical Research Center in Jerusalem, Israel. Twelve patients were allocated to receive two treatments each and four patients were allocated to receive four treatments each. All patients continued to receive their usual therapy (calcium supplements
plus alfacalcidol or calcitriol).
Preliminary results from Part 1 of this study, were reported by Entera Bio in a press release in November 2018. The full study data
analyses presented at the ASBMR meeting demonstrated a positive impact of Oral PTH on three metabolic parameters - serum calcium, phosphate, and 1,25-dihydroxyvitamin D (“active” vitamin D) - in patients with hypoparathyroidism treated with oral hPTH
(1-34) 2.25 mg QID. There was also a decrease in 24-hour urine calcium.
The full data set is being prepared for publication in a
leading medical journal, and the poster presentation is available on the “Events” section of Entera Bio website.
The conclusions of the poster presentation indicate that:
|
◾
|
Oral hPTH(1-34) 2.25 mg QID for one day is associated with an increase in serum albumin-corrected calcium and 1,25(OH)2D
(1,25-dihydroxyvitamin D), a decrease in serum phosphate, and a decrease in urinary calcium in patients with hypoparathyroidism. The patients also received calcium supplements and either alfacalcidol or calcitriol.
|
|
◾
|
Oral PTH produced similar biological effects to Natpara® 100 µg QD, the highest dose of hPTH (1-84) currently indicated for use in patients with hypoparathyroidism, on serum calcium, phosphate and Vit D. Additionally, Oral hPTH (1-34) effected a decrease in
urinary calcium. These changes in serum PD parameters were sustained over the 24-hour period of observation from time zero.
|
|
◾
|
BID, TID and QID regimens showed a dose-dependent increase in 1,25(OH)2D indicating that the long-term treatment,
even with the less frequent regimens, may be an effective treatment option for those patients suffering from less severe hypoparathyroidism.
|
|
◾
|
Treatment with Oral hPTH (1-34) dosed at multiple times during the day has the potential to reduce calciuria generally
associated with maintenance of serum calcium within the normal range using calcium supplements and calcitriol analogs alone.
|
|
◾
|
There were no treatment-emergent adverse events of hypercalcemia, as well as no treatment-emergent Serious Adverse Events
reported in the study.
|
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 77,000
individuals in the United States. Historically, the treatments for hypoparathyroidism have been calcium supplements and active vitamin D (calcitriol or alfacalcidol). Phosphate binders and thiazide diuretics that reduce urine calcium are
occasionally added. It is often difficult to titrate the dose of active vitamin D without producing increased urine calcium or hypercalcemia with tissue calcification during chronic use, 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.
2
*Natpara® is the brand name used in United States for Natpar® which is sold by Takeda
in Europe. Natpar® was used in this Phase 2 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 a human
parathyroid hormone analog, Oral PTH (1-34), for treatment of hypoparathyroidism and osteoporosis.
Entera has developed a
proprietary platform technology that enables oral delivery of biologicals and large molecule drugs, which are typically delivered via injections and or other non-oral pathways. However, oral drug delivery is the easiest method for
self-administering medications, offers patients greater dosing flexibility, and has the highest patient acceptance and compliance rates as compared to all other routes of drug administration. The Company employs this technology for its own pipeline
products and may enter into licensing agreements with biopharma companies for application of the technology to their proprietary compounds, such as the Amgen strategic research collaboration. For more information on Entera Bio, visit www.enterabio.com.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.
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. Those risks and uncertainties, include, but are not limited to, the timing and conduct of our clinical trials, the clinical utility of our product candidates, the
timing and likelihood of regulatory filings and approvals, our intellectual property position, and our financial position. 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 Annual Report on Form 20-F 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.
3