UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 6, 2022
(Exact Name of Registrant as Specified in Its Charter)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933
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Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01 Other Events.
On October 6, 2022, Entera Bio Ltd., a company organized under the laws of the State of Israel (the “Company”), announced the conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (“FDA”) that a single Phase 3 placebo-controlled study could support a New Drug Application (“NDA”) submission of EB613 (oral hPTH
(1-34), teriparatide tablets) under the 505(b)(2) regulatory pathway. The FDA also agreed that Total Hip Bone Mineral Density (“BMD”) could serve as the
primary endpoint of the registrational study in post-menopausal osteoporosis patients.
The single pivotal Phase 3 clinical trial includes a 24-month placebo-controlled duration with change in Total Hip BMD assessed as
the primary endpoint. The 2:1 randomization (EB613 vs. placebo) and planned 400 patients exposed to EB613 are expected to be sufficient to support both the safety and efficacy assessments for the NDA. Furthermore, the FDA agreed with the
Company’s proposed enrollment of post-menopausal women with osteoporosis based on a BMD T-score of ≤-2.5 to 3.0 and no major fracture history. This patient population is consistent with that studied during the Company’s Phase 2 6-month dose
ranging study of EB613, which met all primary and key secondary endpoints of biochemistry and BMD. Finally, the Company intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of
teriparatide, Forteo® to support the 505(b)(2) pathway. The Company expects to initiate patient enrollment for this Phase 3 clinical trial in 2023.
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.
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ENTERA BIO LTD.
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Date: October 6, 2022
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By:
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/s/ Miranda J. Toledano
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Name: Miranda J. Toledano
Title: Chief Executive Officer
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