Current Report Filing (8-k)
April 23 2018 - 7:01AM
Edgar (US Regulatory)
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):
April 18, 2018
SYNTHETIC BIOLOGICS, INC.
(Exact name of registrant as specified in
its charter)
Nevada
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001-12584
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13-3808303
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(State or other jurisdiction of
incorporation)
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(Commission File No.)
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(I.R.S. Employer Identification No.)
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9605 Medical Center Drive, Suite 270
Rockville, MD 20850
(Address of principal executive offices
and zip code)
Registrant’s telephone number, including
area code: (301) 417-4364
N/A
(Former name or former address, if changed
since last report)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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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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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate by check mark whether the registrant is an emerging
growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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If an emerging growth company, indicate
by checkmark 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.
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Item 8.01 Other Events
Synthetic Biologics, Inc. (the “Company”)
today issued a press release announcing it has reached preliminary agreement with the U.S. Food & Drug Administration (FDA)
on a proposed clinical trial synopsis for its planned Phase 3 clinical trial for SYN-004 (ribaxamase). In accordance with recommendations
and guidance from the FDA, the Company expects the Phase 3 trial to include separate co-primary endpoints designed to evaluate
the efficacy and safety of ribaxamase in a patient population being treated with a representative selection of intravenous (IV)
beta-lactam antibiotics. The Company expects the primary efficacy endpoint will be the reduction in CDI incidence in the ribaxamase
treatment group relative to placebo, while the separate, co-primary safety endpoint is expected to be relative mortality risk
between the groups. The designation of efficacy and safety as separate and decoupled endpoints is critical for clinical studies
of this nature, where the underlying population is projected to have a comparatively high incidence of safety events that may
significantly dilute the smaller number of CDI events. The Company also announced that, based on FDA’s additional review
of additional data submitted by the Company during the development of the proposed Phase 3 clinical trial, the ribaxamase program
no longer met the requirements for Breakthrough Therapy Designation due to the numerical imbalance in fatal adverse events observed
in the study which could not be fully evaluated due to the limited safety database, and the study’s method of statistical
treatment of patients who did not complete the study for any reason. As a result, and with the consent of the FDA, the Company
has voluntarily withdrawn the Breakthrough Therapy Designation and has reached agreement with the FDA on how each of these factors
will be addressed in the Phase 3 trial.
The press release attached as Exhibit 99.1
to this Current Report on Form 8-K, which is incorporated herein by reference includes “safe harbor” language pursuant
to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained in the slide
presentation are “forward-looking” rather than historical.
The Company undertakes no duty or obligation
to update or revise information included in this Current Report on Form 8-K or the press release attached as Exhibit 99.1 hereto.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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 hereunto duly authorized.
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SYNTHETIC BIOLOGICS, INC.
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Date: April 23, 2018
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By:
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/s/ Steven A. Shallcross
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Name:
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Steven A. Shallcross
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Title:
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Interim Chief Executive Officer/Chief Financial Officer
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