Positive Phase Ia and Ib Data on SYN-004
More good news this morning!
Synthetic Biologics Announces Positive Pharmacokinetics Data from Phase 1a and 1b Trials of SYN-004 to Protect the Microbiome and Prevent C. difficile Infection
-- Supportive Evidence for No Active Enzyme Absorption into Bloodstream Observed in Phase 1 Studies --
-- Results Pave Way for Phase 2a Clinical Trial to Start this Month --
ROCKVILLE, Md., March 19, 2015 /PRNewswire/ Synthetic Biologics (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced positive pharmacokinetics (PK) results from both the Phase 1a and 1b studies of SYN-004, which is being developed to protect the microbiome and prevent Clostridium difficile (C. difficile) infection.
"The PK data confirmed that SYN-004 acts as Synthetic Biologics intended. SYN-004 goes directly to the gut where intravenous (IV) antibiotics are excreted, with the intention of protecting the microbiome from a cascading set of events that often lead to potentially deadly C. difficile infections," said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. "These data support our expectations that SYN-004 should have no effect on the IV antibiotic in the bloodstream, therefore allowing the antibiotic to do its job and fight the primary infection. We look forward to continuing the clinical evaluations of our lead candidate, SYN-004, with the initiation of a Phase 2a clinical trial this month."
The Phase 1a, single-ascending dose PK study provided data to support Synthetic Biologics' hypothesis that SYN-004 taken orally was not systemically available in the dose range tested. The PK data from this study measured blood levels of a single dose of SYN-004 in participants over a 10-fold dose range. Minimal levels of SYN-004 were observed in the bloodstream across the dose range investigated in the participants.
The Phase 1b, multiple-ascending dose PK study provided data to further support that SYN-004 is not systemically available, as no meaningful levels of SYN-004 were observed in the bloodstream after participants received multiple doses of SYN-004 four times a day over a seven-day period. The PK data confirm Synthetic Biologics' expectations based on previous data from the first generation enzyme (P1A).
In addition, no clinically significant safety events were observed, and both the single and multiple doses of SYN-004 were well tolerated by the participants of the Phase 1 studies. Synthetic Biologics intends to continue the clinical development of SYN-004 in a Phase 2a clinical trial to evaluate the ability of SYN-004 to degrade residual IV antibiotic in the gastrointestinal (GI) tract, therefore potentially protecting the gut microbiome and preventing C. difficile infection.
Currently, there is no vaccine or drug approved by the U.S. Food and Drug Administration (FDA) specifically for the prevention of C. difficile infection. The U.S. Centers for Disease Control and Prevention (CDC) has identified C. difficile infection as an "urgent public health threat" that occurs mostly in people who have had recent medical care with IV antibiotics. SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infectionsi and 30,000 C. difficile-related deathsii in the United States each year. Approximately 118 million doses of IV beta-lactam antibioticsiii that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.
