Thursday, March 19, 2015 9:28:52 AM
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.
Recent TOVX News
- Form 8-K - Current report • Edgar (US Regulatory) • 10/16/2024 12:10:19 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 10/03/2024 08:12:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/03/2024 12:10:40 PM
- Form SC 13G - Statement of Beneficial Ownership by Certain Investors • Edgar (US Regulatory) • 10/02/2024 02:53:47 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 09/30/2024 09:13:32 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 09/27/2024 07:20:19 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 09/26/2024 08:10:34 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/26/2024 04:15:15 AM
- Form S-1/A - General form for registration of securities under the Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/23/2024 12:20:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/23/2024 12:10:25 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 09/18/2024 09:06:44 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 12:10:34 PM
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/11/2024 12:45:02 PM
- Form S-1 - General form for registration of securities under the Securities Act of 1933 • Edgar (US Regulatory) • 09/10/2024 09:03:04 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/09/2024 09:11:02 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/26/2024 12:22:48 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 08:21:23 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/13/2024 12:16:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/13/2024 12:05:30 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/31/2024 12:20:14 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/23/2024 12:20:22 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/16/2024 11:30:14 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/07/2024 11:10:40 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 11:05:32 AM
SANUWAVE Announces Reverse Stock Split, Note and Warrant Exchange, and PIPE Offering • SNWV • Oct 18, 2024 9:31 AM
Vocodia Addresses Recent Stock Price Movement and Future Strategic Partnerships • VHAI • Oct 18, 2024 9:00 AM
Mass Megawatts Announces the Start of an Online Discount Solar Energy Equipment Business with Revenue Recognized for the First Time Since Year 2010 in this Fiscal Quarter • MMMW • Oct 18, 2024 7:32 AM
Unitronix Corp Advances DeFi Innovation with Tokenized Real-World Assets Integration • UTRX • Oct 17, 2024 7:38 AM
Mass Megawatts Commences Solar Energy Sales Efforts • MMMW • Oct 16, 2024 7:45 AM
SANUWAVE Health Announces 1-For-375 Reverse Stock Split • SNWV • Oct 16, 2024 7:40 AM