Tag Archives: Synthetic Biologics SYN-004

Synthetic Biologics SYN-004 Intended for the Prevention of C. diff. Infection (CDI) and Antibiotic-Associated Diarrhea (AAD)

UPDATE:

Synthetic Biologics Announces Further U.S. Patent Successes Covering SYN-004 Intended for the Prevention of C. difficile Infection and Antibiotic-Associated Diarrhea

 

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome, announced today that the U.S. Patent and Trademark Office (USPTO) issued Notices of Allowance for three patent applications which cover composition of matter claims and methods of protecting the gut microbiome from certain beta-lactam antibiotics for the prevention of C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). These new allowances further strengthen the Company’s novel proprietary candidate, SYN-004, which is also covered by a composition of matter patent in the U.S.

 

 Synthetic Biologics, Inc. www.syntheticbiologics.com

What is SYN-004? 

SYN-004  is designed to degrade certain intravenous (IV) beta-lactam antibiotics excreted into the gastrointestinal (GI) tract to maintain the natural balance of the gut microbiome. C. difficile is associated with approximately 453,000 CDIs and > 29,000 C. difficile-related deaths in the United States each year[i].

Upon issuance, these newly allowed applications reinforce Synthetic Biologics’ extensive C. difficile-related patent estate, which includes approximately 35 U.S. and foreign patents and approximately 30 U.S. and foreign patent applications, and carry patent terms that extend from at least 2031 to 2035.

“These new patents will complement our growing SYN-004 patent estate and support our C. difficile prevention program, including two ongoing Phase 2 clinical trials,” said Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “We’re on schedule with respect to patient enrollment in our global Phase 2b proof-of-concept clinical trial intended to evaluate the ability of SYN-004 to prevent CDI and AAD in patients hospitalized with a lower-respiratory tract infection. During the first half of 2016, we also anticipate announcing topline data from the second Phase 2a clinical trial which is evaluating the ability of SYN-004 to degrade IV ceftriaxone in the presence of a proton pump inhibitor.”

About Synthetic Biologics, Inc. For more information, please visit Synthetic Biologics’ website at 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.

Synthetic Biologics Announced Positive Topline Results From the First Phase 2a Study Of SYN-004 For C. difficile Infection Prevention

syntheticbiologics
Synthetic Biologics Announces Positive Topline Results from First Phase 2a Clinical Trial of SYN-004, the Company’s Candidate for the Prevention of C. difficile Infection

Synthetic Biologics, Inc. a clinical stage company focused on developing therapeutics to protect the gut microbiome while targeting pathogen specific diseases, announced positive topline results from the first Phase 2a study of SYN-004, the Company’s candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention C. difficile infection (CDI) and antibiotic-associated diarrhea (AAD). Topline results from the ten ileostomized participants who completed the Phase 2a open-label study demonstrated that SYN-004 successfully degraded residual IV ceftriaxone in the chyme (digestive fluid in the small intestine) without affecting the intended level of ceftriaxone in the bloodstream.

Evaluation of the chyme from the ileostomized participants indicates that both dosage strengths of SYN-004 (75 mg and 150 mg) degrade residual IV ceftriaxone present in the chyme, supporting the mechanism of action of SYN-004. In addition, both dosage strengths of SYN-004 appear to be well tolerated by the participants in the study. Overall, the topline data support the hypothesis that SYN-004 has the capacity to degrade residual IV ceftriaxone in the GI tract, thereby preserving the balance of the gut microbiome for the prevention of CDI, AAD and emergence of antibiotic-resistant organisms, without affecting the antibiotic level in the bloodstream intended for treatment of a primary infection.

“The completion of the first Phase 2a clinical trial for SYN-004 is an important achievement for Synthetic Biologics. These positive topline results demonstrate the potential for SYN-004 to protect the gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea,” stated Jeffrey Riley, President and Chief Executive Officer of Synthetic Biologics. “The second Phase 2a clinical trial for SYN-004 is currently ongoing to evaluate the GI antibiotic-degrading effects and the safety of SYN-004 in the presence of the proton pump inhibitor (PPI), esomeprazole, in participants with functioning ileostomies. We anticipate reporting topline results from the second Phase 2a of SYN-004 during the first half of 2016.”

Mr. Riley concluded, “We are pleased to report additional progress from our SYN-004 program. We have begun dosing patients in the SYN-004 Phase 2b proof-of-concept clinical trial that is intended to evaluate the effectiveness of SYN-004 to prevent C. difficile infection and C. difficile associated diarrhea, as well as antibiotic-associated diarrhea in up to 370 patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.”

 

First SYN-004 Phase 2a Clinical Trial Design

The Phase 2a randomized, multi-center, open-label study evaluated the ability of two different dose strengths of SYN-004 to degrade residual IV ceftriaxone in the GI tract of 10 healthy participants with functioning ileostomies, without affecting the concentrations of IV ceftriaxone in the bloodstream. The study consisted of two treatment phases for all participants: 1) the administration of IV ceftriaxone alone, and 2) the administration of IV ceftriaxone with one of two dosage strengths of oral SYN-004. Chyme samples were collected from the participants to measure the capability of SYN-004 to degrade the residual antibiotic in the GI tract. Participants were enrolled at two trial sites located in Canada.

 

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

http://money.cnn.com/news/newsfeeds/articles/prnewswire/CL69745.htm

 

— SYN-004 Degraded IV Ceftriaxone in Gastrointestinal Tract without Affecting
Antibiotic Levels in the Bloodstream —
— First Patients Dosed in Phase 2b Proof-of-Concept Clinical Trial for SYN-004 —
— SYN to Host Microbiome Clinical Program Seminar in NYC on Thursday, December 10, 2015

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 gut microbiome from the damaging effects of certain IV beta-lactam antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea, the timing of the reporting of topline results from the second Phase 2a of SYN-004, the potential market for SYN-004, and the intended therapeutics results of SYN-004 and SYN-010. 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, a failure to receive the necessary regulatory approvals for commercialization of Synthetic Biologics’ therapeutics, a failure of Synthetic Biologics’ clinical trials, and those conducted by investigators, to be commenced or completed on time or to achieve desired results, a failure of Synthetic Biologics’ clinical trials to receive anticipated funding, a failure of Synthetic Biologics’ products for the prevention and treatment of diseases to be successfully developed or commercialized, Synthetic Biologics’ inability to maintain its licensing agreements, or a failure by Synthetic Biologics or its strategic partners to successfully commercialize products 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  Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

ii Leffler DA et al. N Engl J Med 2015; 372:1539-1548.

 

 

*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. 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 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. Is Issued a Notice of Allowance for a Composition of Matter Patent Application covering SYN-004, Leading Product in its C. difficile Program

* In the news *

Synthetic Biologics, Inc., a biotechnology company developing novel pathogen-specific therapies for serious infections and diseases, announced that as of October 22, 2014  the U.S. Patent and Trademark Office has issued a Notice of Allowance for a composition of matter patent application that covers the lead product in its C. difficile program, SYN-004. This is Synthetic Biologics’ first allowed patent application directly pertaining to SYN-004 in the U.S. and adds to the Company’s extensive C. difficile patent estate.

Synthetic Biologics, Inc. Logo

SYN-004 is Synthetic Biologics’ novel oral enzyme drug candidate designed as the first and only prophylactic treatment intended to prevent the development of C. difficile infections, by binding with and neutralizing certain intravenous (IV) beta-lactam antibiotics in the gut.

SYN-004 is intended to block the effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of bacterial flora (the gut microbiome), potentially preventing the 1.1 million C. difficile infections in the U.S. each year.  The U.S. patent to be issued has claims to compositions of matter and pharmaceutical compositions of beta-lactamases, including SYN-004, and carries a patent term to at least 2031. In addition to the newly allowed patent, the Company has numerous related granted and pending U.S. and international patent applications that are central to the Synthetic Biologics’ intellectual property estate.

“This new patent will strengthen the protection of Synthetic Biologics’ SYN-004 and reiterates our position as a key player in the prevention of microbiome-based diseases,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “We continue to bolster the Company’s patent estate while making progress towards our goals to initiate Phase Ia and Ib C. difficile clinical trials this quarter.”

 

Resource: Synthetic Biologics news release.

 

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