Tag Archives: Synthetic Biologics

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

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#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 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.

C. difficile Prevention; Synthetic Biologics Safe-to-Proceed Under IND to Initiate Clinical Trials of SYN-004

Phase 1a and 1b Trials to Use SYN-004 to Protect Microbiome; Intended to Prevent Overgrowth of Potentially Deadly C. difficile Bacteria

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that its Investigational New Drug (IND) application which was submitted to the U.S. Food and Drug Administration (FDA) in October will be proceeding into clinical trials for the development of the Company’s oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous (IV) beta-lactam antibiotic therapy. Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end.

 

“We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of 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. “Taking immediate and aggressive action to develop a therapy that can prevent C. difficile before it starts is critical in addressing this pervasive and life-threatening infection, and IND activation for SYN-004 is a key step toward the development and eventual commercialization of therapy to protect the millions of at risk U.S. patients.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only prophylactic treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV beta-lactam antibiotics in the gut. SYN-004 is intended to block the unintended harmful effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infectionsii and 30,000 C. difficile-related deathsiii in the U.S. each year.

Synthetic Biologics has met each milestone for its C. difficile program leading up to the IND submission to the agency. Clinical drug manufacturing of SYN-004 under cGMP guidelines to support Synthetic Biologics’ planned Phase 1 and 2 clinical trials was completed on time to support the IND submission and clinical trial initiation. Most recently, the U.S. Patent and Trademark Office issued a Notice of Allowance for the first composition of matter patent application directly pertaining to SYN-004 in the U.S., which carries a patent term to at least 2031.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage biotechnology company developing pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome. The Company is developing an oral biologic to protect the gastrointestinal (GI) microflora from the effects of intravenous (IV) antibiotics for the prevention of C. difficile infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS) and a monoclonal antibody combination for the treatment of Pertussis being developed in collaboration with Intrexon Corporation (XON). 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. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

For  the complete Press Release article – click on the following link:

https://ca.finance.yahoo.com/news/synthetic-biologics-safe-proceed-under-115700305.html


Synthetic Biologics, Inc. and Enterome Bioscience SA enter into researching effects of beta-lactam antibiotics on the Microbiome

NewsSpeaker

 

Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases, and Enterome Bioscience SA, a pioneer in the development of innovative disease management solutions based on a deep understanding of the gut microbiome, today announced that they have entered into an agreement to conduct metagenomic research on the effects of beta-lactam antibiotics on the gastrointestinal microflora (microbiome) of human patients. As part of this collaboration, a clinical microbiome study of approximately 100 patients is expected to begin next month. Research findings should provide important insights as Synthetic Biologics advances the development of SYN-004, which is intended to protect the gut microbiome from the effects of intravenous (IV) beta-lactam antibiotics, and in particular to prevent C. difficile (C. diff) infections. Phase Ia and Ib clinical trials of Synthetic Biologics’ SYN-004 are scheduled to begin later this year.

The Enterome microbiome study, scheduled for completion in the second half of 2014, is expected to provide a better understanding of the harmful effects of beta-lactam antibiotics on the gut bacterial community. The goal is to establish a “fingerprint” of the damage caused by beta-lactam antibiotics, thus yielding a panel of bacterial biomarkers that can be leveraged for diagnostic purposes. This novel study should clearly define the impact of beta-lactam antibiotics on the natural bacterial diversity of the gut microbiome. Changes in the gut microbiome have been related to multiple diseases, including C. diff infections, antibiotic-associated diarrhea, obesity, diabetes and other metabolic diseases. This study will utilize Enterome’s state-of-the-art shotgun metagenomic sequencing technology to profile the human gut microbiome.

“We are pleased to establish this collaboration with Enterome, a pioneer in the development of biomarkers and therapies for diseases of the gut microbiome,” stated Jeffrey Riley, CEO of Synthetic Biologics. “Findings from this study should support our C. diff therapeutic program, which focuses on protecting and maintaining the balance of bacterial microflora in the gut, while also establishing our presence in Europe.”

Synthetic Biologics’ lead anti-infective product candidate, SYN-004, is the first therapy designed to neutralize IV antibiotics in the gut, and is intended to protect and maintain the balance of bacterial flora in the gastrointestinal tract, to prevent the devastating effects of C. diff. The U.S. Centers for Disease Control and Prevention (CDC) has classified C. diff as an “urgent public health threat”i, surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annuallyii. In the U.S., patients with C. diff are hospitalized an estimated 3.6-7 extra daysiii, costing more than $8.2 billioniv.

“The signing of this agreement with Synthetic Biologics is another important corporate milestone for Enterome. I am very pleased that our pioneering approach to understanding the linkage between changes in the gut microbiome and disease has convinced Synthetic Biologics to work with us on such an important personalized medicine project. It is clear that new diagnostic solutions are needed to properly address the growing problem of antibiotic-induced dysbiosis and associated hospital-acquired bacterial infections,” stated Pierre Belichard, CEO of Enterome. “Tailoring the use of anti-infective treatments based on microbiome profiling is beginning to show great promise as a way to address the management of infectious diseases.”

“Comparing Enterome’s technology to other genomic analyses of gut microbiome is like comparing a Quad Full High definition color resolution TV to resolution of an analog black & white TV,” added Mr. Riley.

About SYN-004 Clinical Development

Synthetic Biologics is developing SYN-004, a novel second generation oral enzyme drug candidate, to be co-administered with commonly used IV beta-lactam antibiotics and is intended to protect the gastrointestinal microflora (microbiome) from the harmful effects of such antibiotics, thus potentially preventing C. diff infections. Planned next steps for SYN-004 include: 1) initiation of a 28-day bridging toxicology study in June 2014; 2) filing of an Investigational New Drug (IND) application to initiate Phase Ia and Ib clinical trials in the second half of 2014, with preliminary topline data expected by year-end 2014; and, 3) initiation of a Phase II efficacy study is expected to begin in the first half of 2015.

About Enterome Bioscience SA

Enterome is pioneering the development of innovative disease management solutions based on a deep understanding of the gut microbiome. Understanding and modifying the changes that occur in the gut microbiome during disease and in response to therapeutic interventions represent an entirely new and untapped opportunity to impact medicine.

Initially Enterome is using its expertise and proprietary technologies to develop novel diagnostic products to support patient stratification, personalized therapies and the clinical development of new drugs for the treatment of microbiome-related diseases such as inflammatory bowel diseases and metabolic diseases (diabetes and obesity). Enterome’s unique Metagenotyping® process has allowed it to develop biomarkers for treatment response prediction, disease activity monitoring and as potential companion diagnostics.

The company was established in 2012 in Paris, France, and has raised a total of €17.5m from leading venture capital investors (Seventure, Omnes Capital & Lundbeckfond Ventures) and two strategic investors (Danone & Shire).  www.enterome.com

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a biotechnology company focused on the development of novel anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and diseases. The Company is developing an oral biologic to protect the gastrointestinal microflora from the effects of IV antibiotics for the prevention of Clostridium difficile (C. difficile) infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS), a series of monoclonal antibodies for the treatment of Pertussis and Acinetobacter infections, and a biologic targeted at the prevention and treatment of a root cause of a subset of IBS. In addition, the Company is developing an 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.

 

* For article in its entirety please click on the following link:

http://www.prnewswire.com/news-releases/synthetic-biologics-and-enterome-bioscience-collaborate-on-microbiome-research-to-support-synthetic-biologics-c-difficile-program-262479001.html

Synthetic Biologics SYN-004 Oral Enzyme for C. difficile prevention

* In the news  31 March 2014 *
Prevention of C. difficile (C. diff.) Infections – SYN-004 Oral Enzyme

Manufacturing is underway to support preclinical and clinical trials of SYN-004,  Synthetic Biologics’ lead anti-infective product candidate, which is believed to be the first and only therapy designed to potentially prevent the devastating effects of C. diff. The Center for Disease Control and Prevention (CDC) has classified C. diff as an “urgent public health threat”[ii], surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annually[iii]. Plans remain on schedule to initiate a 28-day bridging toxicology study of the Company’s second generation candidate late in the second quarter of 2014. Synthetic Biologics expects to file an IND and to initiate Phase Ia and Ib clinical trials during the second half of 2014 for its C. diff program.

 

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

http://www.prnewswire.com/news-releases/synthetic-biologics-reports-year-end-2013-financial-results-and-operational-update-253172521.html

 

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