SYNTHETIC BIOLOGICS, INC. (NYSEMKT:SYN) Files An 8-K Other Events
Item 8.01 Other Events
Synthetic Biologics, Inc. (the Company) today issued a press
release announcing positive topline data from its Phase 2b
clinical trial for SYN-004 (ribaxamase), the Companys
first-in-class oral enzyme designed to protect the gut microbiome
from disruption caused by certain intravenous (IV) beta-lactam
antibiotics. The trial, a randomized, double-blind, placebo
controlled trial of 412 patients, met its primary endpoint of
significantly reducing C. difficile Infection (CDI).
Preliminary analysis of the data indicates seven confirmed cases
of CDI in the placebo group compared to two cases in the
ribaxamase treatment group. Patients receiving ribaxamase
achieved a 71.4% relative risk reduction (p-value=0.045) in CDI
rates compared to patients receiving placebo. Adverse events
reported during this trial were comparable between treatment and
Synthetic Biologics is also in the process of analyzing data from
several exploratory endpoints that were designed to evaluate
ribaxamases ability to protect the gut microbiome from
colonization by opportunistic bacteria such as C.
difficile and other antibiotic-resistant pathogens.
Preliminary analysis of the data demonstrated a significant
reduction in new colonization by vancomycin-resistant enterococci
(VRE) for patients receiving ribaxamase compared to placebo
(p-value=0.0002). The study included a secondary endpoint to
assess ribaxamases capacity to decrease the incidence of
antibiotic-associated diarrhea from all cases. Preliminary
analysis of the data suggested a trend towards such a reduction
(p-value=0.13), which was due, for the most part, to the
reduction of CDI.
These data are consistent with ribaxamases mechanism of action
designed to protect and preserve the natural balance of the gut
microbiome from the unintended effects of IV antibiotic use. The
Company expects to share additional results from these
exploratory endpoints as they become available later this year,
including results focused on ribaxamases ability to prevent the
emergence of antimicrobial resistance in the gut microbiome.
The press release is attached as Exhibit 99.1 to this report on
Form 8-K and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
|99.1||Synthetic Biologics, Inc. press release dated January 5, 2017|
About SYNTHETIC BIOLOGICS, INC. (NYSEMKT:SYN)
Synthetic Biologics, Inc. is a clinical-stage company. The Company is engaged in developing therapeutics to protect the gut microbiome while targeting pathogen-specific diseases. The Company’s lead product candidates in Phase II development are SYN-010, which is intended to reduce the impact of methane-producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and SYN-004, which is designed to protect the gut microbiome (gastrointestinal (GI) microflora) from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). Its other product candidates include SYN-007, SYN-006, SYN-005, SYN-200 and SYN-020. The Company is also developing preclinical-stage monoclonal antibody therapies for the prevention and treatment of pertussis, and discovery-stage biotherapeutics for the treatment of phenylketonuria (PKU). SYNTHETIC BIOLOGICS, INC. (NYSEMKT:SYN) Recent Trading Information
SYNTHETIC BIOLOGICS, INC. (NYSEMKT:SYN) closed its last trading session up +0.028 at 0.910 with 1,241,598 shares trading hands.