Tag Archives: SYN-004

C. difficile Clinical Trial News; Synthetic Biologics Initiates SYN-004 Phase 2b Proof-of-Concept Clinical Trial

In The News……

Study to Evaluate SYN-004’s Ability to Prevent C. difficile Infection and Antibiotic-Associated Diarrhea
Phase 2b Trial Expected to Enroll Approximately 370 Patients at up to 75 Global Clinical Sites

Synthetic Biologics, a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, reported the initiation of its SYN-004 Phase 2b proof-of-concept clinical trial. The clinical trial is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection (CDI), C. difficile associated diarrhea (CDAD) and antibiotic-associated diarrhea (AAD) in patients hospitalized for a lower respiratory tract infection and receiving intravenous (IV) ceftriaxone.

C. difficile is the leading type of hospital acquired infection and is frequently associated with IV antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone. However, antibiotics have the potential to cause harmful effects within the gastrointestinal (GI) tract including disruption of the natural balance of the gut microbiome, leading to 1.1 million CDIsi and 30,000 C. difficile-related deathsii in the United States each year.

SYN-004 is Synthetic Biologics’ oral prophylactic therapy designed to degrade certain IV beta-lactam antibiotics within the GI tract and maintain the natural balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms.

To view the SYN-004 mechanism of action video on Synthetic Biologics’
website, please click here.

“Initiating the SYN-004 Phase 2b clinical trial is an important milestone for Synthetic Biologics as it is intended to assess the proof-of-concept of SYN-004, which is designed to protect the microbiome and prevent CDIs and AAD,” stated Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Several Phase 2b clinical sites are open for enrollment and actively screening for patients with additional sites expected to open as we approach the cold and flu season.”

Mr. Riley added, “Before initiating the SYN-004 Phase 2b clinical trial, safety and tolerability was demonstrated in two Phase 1 studies: a single-ascending dose study and a multiple-ascending dose study. Full analysis was completed and study reports were submitted to the FDA.

“In addition, our novel Phase 2a clinical trials are evaluating the GI antibiotic-degrading effects and the safety of SYN-004, both alone and in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with ileostomies (colon and rectum removed, or just part of small intestine removed). They are intended to generate additional pharmacokinetics (PK) and pharmacodynamics (PD) data to support SYN-004, and in the case of the PPI study, to analyze any potential drug-drug interactions.

“We have now enrolled enough participants to complete the first Phase 2a trial analysis, even though the recruitment of qualified ileostomized participants was slower than anticipated. We are very grateful to these at-risk participants for being a part of these studies and helping us further the development of SYN-004 for the prevention of CDIs and AAD. The Phase 2a studies are ongoing and we will report topline data from each of them when full data analysis is available. We anticipate results will be consistent with our expectations and the positive PK and safety results demonstrated in the SYN-004 Phase 1a and 1b studies previously reported in March 2015, and in the first four participants in the first Phase 2a previously reported in July 2015.”

SYN-004 Phase 2b Proof-of-Concept Clinical Trial Design

The Phase 2b, parallel-group, double-blind, placebo-controlled study of SYN-004 is expected to enroll approximately 370 patients at up to 75 global clinical sites. Patients age 50 years and older, hospitalized for a lower respiratory tract infection, are expected to be randomized 1:1 into two groups, and receive either SYN-004 or placebo during the standard of care regimen of ceftriaxone (with or without a macrolide). The primary objectives of this clinical trial are to evaluate the effectiveness of SYN-004 to prevent CDIs and CDAD. The secondary objective of this clinical trial is to evaluate the effectiveness of SYN-004 to prevent AAD.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and in collaboration with Intrexon Corporation (NYSE: XON), a monoclonal antibody combination for the treatment of Pertussis and biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
ii U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: June 7. 2015.

In The News – Synthetic Biologics’ SYN-004 Microbiome-Protecting Preclinical Data Highlighted in Late-Breaking Poster at DDW 2015

syntheticbiologics

Synthetic Biologics, Inc.  a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, presented preclinical results in a late-breaking poster at Digestive Disease Week® (DDW) 2015 in Washington, DC today. The research supports the development of SYN-004, the Company’s candidate therapy designed to degrade certain intravenous (IV) beta-lactam antibiotics within the gastrointestinal (GI) tract and maintain the natural balance of the gut microbiome for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD). Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.

The “SYN-004, a Clinical Stage Oral Beta-Lactamase Therapy, Protects the Intestinal Microflora from Antibiotic-Mediated Damage in Humanized Pigs” poster summarized preclinical efficacy data that support the ability of SYN-004 to degrade certain beta-lactam antibiotics in the GI tract, with the following conclusions:

  • In fistulated dogs, oral delivery of SYN-004 resulted in efficient degradation of ceftriaxone in the GI tract, and
  • In humanized pigs, SYN-004 protected the intestinal microflora from ceftriaxone and maintained the natural balance of the microbiome.

“The data suggest that SYN-004 has the potential to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, including C. difficile infection, in patients receiving beta-lactam antibiotics,” stated Michael Kaleko, M.D., Ph.D., Senior Vice President, Research & Development of Synthetic Biologics.

“These findings support our ongoing Phase 2a clinical trial that is evaluating the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream,” noted Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

“We are on schedule to report topline data from the Phase 2a clinical trial of SYN-004 this quarter, with a Phase 2b clinical trial anticipated to initiate during the second half of this year.”

The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an “urgent public health threat,” and has stated the need for research to better understand the role of normal gut bacteria. SYN-004 is intended to block the unintended harmful effects of certain IV antibiotics within the GI tract and maintain the natural balance of the gut microbiome, potentially preventing the 1.1 million C. difficile infections[i] and 30,000 C. difficile-related deaths[ii] in the United States each year. Approximately 118 million doses of IV beta-lactam antibiotics[iii] that could be inactivated in the GI tract by SYN-004, were administered to approximately 14 million hospitalized U.S. patients during 2012.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company is developing an oral biologic to protect the gut microbiome from intravenous (IV) antibiotics for the prevention of C. difficile infection and an oral statin treatment to reduce the impact of methane producing organisms on irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a monoclonal antibody combination for the treatment of Pertussis in collaboration with Intrexon Corporation (NYSE: XON), and a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements regarding the potential for SYN-004 to protect the human microbiome and to become the first prophylactic therapy designed to prevent antibiotic-mediated microbiome damage, anticipated timing of the topline data from the Phase 2a and the initiation of the Phase 2b clinical trial and the size of the market. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, the ability of SYN-004 to perform as expected, the results of the clinical trials and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.


[i] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[ii] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

[iii] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

 

Synthetic Biologics Discuss Preventing C. diff. Infection with SYN-004 on “C diff Spores and More,” C. diff. Radio

cdiffRadioLogoMarch2015

 

Join us on Tuesday, March 31st at 11:00 a.m. Pacific, 1 p.m. Central, 2 p.m. Eastern Time for the live broadcast –  Synthetic Biologics: Preventing C. diff. Infection with SYN-004

 

 

 

Synthetic Biologic, Inc.’s  Lewis Barrett, BS, MBA, Senior Vice President, Commercial Strategy and Dr. Joseph A. Sliman, MD, MPH, Senior Vice President, Clinical & Regulatory Affairs will discuss the novel point-of-care preventive approach, the clinical development pathway and the potential of the Company’s lead pathogen-specific product candidate, SYN-004.

 

For direct access to the “C. diff. Spores and More Program” please click on the link below:

http://www.voiceamerica.com/episode/84381/synthetic-biologics-preventing-c-diff-infection-with-syn-004

 

The majority of C. difficile cases are caused by the unintended consequences of antibiotic therapy to the gut microbiome. Intravenous (IV) antibiotics excreted to the gut often wipe out the natural balance of microflora, which can lead to recurring diarrhea and perforation of the intestinal wall, with potentially fatal outcomes. Co-administered with IV
antibiotics, Synthetic Biologics’ product candidate, SYN-004, is designed to be a preventive therapy intended to protect the gut microbiome by degrading IV antibiotics, thereby preventing the onset  of  a C. difficile infection.
Synthetic Biologics, Inc. (NYSE MKT:SYN)

http://www.syntheticbiologics.com

 

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

Study Advances Development of Preventative Approach for C. difficile Infection – Synthetic Biologics Initiates Phase 2a Clinical Trial of SYN-004 to Protect the Microbiome and Prevent C. difficile

Study Advances Development of Preventive Approach for C. difficile Infection
Synthetic Biologics, Inc..   a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome,  announced on March 30, 2015, the initiation of a Phase 2a clinical trial to evaluate the gastrointestinal (GI) antibiotic-degrading effects and the safety of SYN-004, the Company’s investigational oral beta-lactamase enzyme designed to protect the microbiome and prevent C. difficile infection (CDI). C. difficile is the leading type of hospital acquired infection and is frequently associated with intravenous (IV) antibiotic treatment. Beta-lactam antibiotics are a mainstay in hospital infection management, and include commonly used penicillin and cephalosporin antibiotics, such as ceftriaxone.
“We are excited to start our Phase 2a trial of SYN-004 on schedule. Synthetic Biologics believes SYN-004 holds the potential to protect the microbiome from the damaging effects of antibiotics and dramatically reduce C. difficile infections through prevention vs. treatment,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We anticipate reporting topline results from this Phase 2a clinical trial during the second quarter of 2015, and initiating the Phase 2b clinical trial in the second half of this year.”
The U.S. Centers for Disease Control and Prevention (CDC) has categorized C. difficile as an “urgent public health threat,” and has stated the need for research to better understand the role of normal gut bacteria. 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 infections and 30,000 C. difficile-related deaths  in the United States each year. During 2012, approximately 14 million U.S. patients received approximately 118 million doses of IV beta-lactam antibiotics that could be inactivated in the GI tract by SYN-004.

https://cdifffoundation.org/2015/02/25/c-diff-new-cdc-study-national-burden-of-clostridium-difficile-c-diff-infections/
The Phase 2a randomized, multi-center, open-label study is expected to evaluate the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of up to 20 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consists of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of one of two doses of oral SYN-004 and IV ceftriaxone. Chyme samples will be collected from the participants to measure the ability of SYN-004 to degrade the residual antibiotic. Participants will be enrolled at up to four trial sites located in the United States and Canada.

For more information visit Synthetic Biologics website:

www.syntheticbiologics.com

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

C. diff. and Healthcare-Associated Infections Discussed Live on C. diff. Radio

CdiffRadioPost

#CdiffRadio

C Diff Foundation, Sponsor, with Founder            Nancy C. Caralla, Executive Director and               Dr. Chandrabali Ghose, Chairperson of the Research and Development Community will be broadcasting live on Tuesdays delivering the most up-to-date information pertaining to a leading super-bug/ Healthcare Associated Infection (HAI),  C. difficile, with additional HAI’s, and a variety of related healthcare topics.

Topic experts will be joining your hosts to discuss prevention, treatments, clinical trials, and environmental safety products on a global level.

Tune in Tuesdays beginning March 3rd at 11 AM Pacific Time (2 PM Eastern Time, 7 PM UK) on the VoiceAmerica network  http://www.voiceamerica.com/show/2441/c-diff-spores-and-more

 

C. difficile Prevention Clinical Trials; Synthetic Biologics Announces Positive Results from Phase 1a of SYN-004

In the news:

Synthetic Biologics Announces Positive Topline Results from Phase 1a Trial of SYN-004 for the Prevention of                C. difficile Infection

Synthetic Biologics, Inc.  a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, announced positive top-line safety and tolerability results from a Phase 1a clinical trial of SYN-004, the Company’s investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection, antibiotic-associated diarrhea and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

Since December 2nd, 2014 the randomized double-blind, placebo-controlled Phase 1a clinical trial conducted at Clinical Pharmacology of Miami, has enrolled 24 healthy volunteers in three cohorts of eight patients each. A total of 18 volunteers have been administered one dose of SYN-004 at increasing dose levels by cohort, and six volunteers received placebo. No clinically significant or relevant adverse events have been reported to date.

“Completing the first safety review and reporting positive top-line results in the Phase 1a clinical trial of SYN-004 is an important event for Synthetic Biologics, bringing us closer to the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat. Achieving this milestone moves us closer to validating our ground-breaking approach to preventing C. difficile infection in a way that protects the gut microbiome, which also holds the hope of treating a variety of GI, metabolic and CNS disorders,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics.

Mr. Riley added, “Based on the results observed in the first three cohorts, and per our clinical plan, we intend to proceed with our planned multiple-ascending dose placebo-controlled Phase 1b study of SYN-004, in which healthy volunteers will receive increasing doses of SYN-004 over several days. We expect enrollment into our Phase 1b SYN-004 clinical trial to begin before year-end, with top-line data available during the first quarter of 2015. We also expect to initiate enrollment in a Phase 2 SYN-004 clinical trial ahead of schedule during the first quarter of 2015.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent C. difficile infection. Its mechanism of action is to bind with and neutralize certain common IV beta-lactam antibiotics in the gut.

During 2012, 14.4 million U.S. patients received approximately 117.6 million doses of IV antibiotics  [i]   that could be inactivated in the gastrointestinal (GI) tract by SYN-004.

SYN-004 is intended to block the unintended harmful effects of antibiotics within the GI tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infections[ii] and 30,000 C.difficile related deaths[iii] in the United States each year.

The U.S. Centers for Disease Control (CDC) has identified C. difficile as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal pain, cramping, nausea, colitis, and even death. In all, 24 million Americans receive IV antibiotics annually  [iv].

References:

[i] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[ii] This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

[iii] U.S. Department of Health & Human Services. Agency for Healthcare Research and Quality. January 25, 2012. http://www.ahrq.gov/news/nn/nn012512.htm Accessed: September 30, 2013.

[iv]  This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

SOURCE Synthetic Biologics, Inc.

For further information: Synthetic Biologics:

Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

To read this article in its entirety please click on the link below:

https://ca.finance.yahoo.com/news/synthetic-biologics-announces-positive-topline-115800549.html

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.

C. difficile Infection Prevention; Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004

Synthetic Biologics Announces First Patient Dosed in Phase 1a Clinical Trial of SYN-004
for the Prevention of C. difficile Infection
First-in-Class Clinical Program Targets Protection of Microbiome to Prevent Overgrowth of deadly C. difficile Infection Linked with Use of IV Antibiotics
Rockville, MD, December 2, 2014 – Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that enrollment has initiated and the first patient was dosed in a Phase 1a clinical trial of SYN-004, an investigational oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary antibiotic-resistant infections in patients receiving intravenous (IV) beta-lactam antibiotic therapy.

The randomized, double-blind, placebo-controlled Phase 1a study, which is now underway at Clinical Pharmacology of Miami, is designed to evaluate the safety, tolerability and pharmacokinetics of five single ascending doses of oral SYN-004 in healthy volunteers.

In all, up to 40 healthy adult volunteers will be enrolled into five cohorts, with approximately six participants receiving SYN-004 and two receiving placebo in each cohort. Before the end of the year, top line Phase 1 data is expected to be reported and a Phase 1b study evaluating multiple-ascending doses of SYN-004 is planned to begin.

“The initiation of the clinical program for SYN-004 represents an important milestone for Synthetic Biologics and a key step towards the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We look forward to moving Synthetic Biologics’ innovative therapeutic approach to prevent C. difficile infection through
clinical development, and further validating the connection between protecting the gut microbiome and a variety of GI, metabolic and CNS disorders.”

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, which the U.S. Centers for Disease Control (CDC) has identified as an “urgent public health threat” and occurs mostly in people who have had recent medical care with IV antibiotics. These antibiotics can create a harmful imbalance in the gut microbiome by killing “good” bacteria, giving C. difficile a chance to multiply and cause diarrhea, which can lead to dehydration, fever, abdominal
pain, cramping, nausea, colitis, and even death.

In all, 24 million Americans receive IV antibiotics annually.
SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV betalactam antibiotics in the gut.

For further information, please contact:
Synthetic Biologics:  Kris Maly, VP, Corporate Communication, (734) 332-7800, info@syntheticbiologics.com

i This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
ii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.
iii This information is an estimate derived from the use of information under license from the following IMS Health Incorporated information service: CDM Hospital database for full year 2012. IMS expressly reserves all rights, including rights of copying, distribution and republication.

iv U.S. Department of Health & Human Services. Agency for Healthcare

 

*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.