Tag Archives: Biological Research and Development Clostridium difficile

C Diff Foundation Recognizes Rebiotix CEO Lee Jones with 2019 ‘Above and Beyond’ Award


C Diff Foundation Board presented Rebiotix CEO Lee Jones for Advocacy, Innovation in
C. difficile infection treatment

 

(NEW PORT RICHEY, Fla.) — The C. Diff Foundation Board of Directors announced that the 2019 “Above and Beyond” Award was presented to Rebiotix CEO Lee Jones in Roseville, Minnesota. The award, given to one recipient annually, is given to a person or organization that show extraordinary dedication to C. diff. patient safety, advocacy, and overall drive to improve the lives of those impacted by the infection.

“We are very proud to recognize Ms. Jones with our “Above and Beyond” award,” said C. Diff Foundation Founder and President, Nancy Caralla. “Lee’s dedication to the entire C.diff. community of patients, family members, and physicians hasn’t wavered since the founding of Rebiotix in 2011. She is a true example of what can happen when focusing on patient well-being drives new approaches to healthcare.”

The award was presented by the Foundation’s Vice President, Scott Battles at the Rebiotix office.

 

 

 

 

 

 

“It’s an honor to receive this award from the C. Diff Foundation,” said Ms. Jones. “The purpose of starting Rebiotix was to bring the power of the microbiome to the clinic in a scientifically sound, quality-controlled way to help patients. We stand with the Foundation in believing that patient well-being should be at the core of all that we do, from clinical trials to exploring new scientific landscapes within the microbiome space.”

About Rebiotix Inc.:

Rebiotix Inc., part of the Ferring Pharmaceuticals Group, is a late-stage clinical microbiome company focused on harnessing the power of the human microbiome to revolutionize the treatment of debilitating diseases. Rebiotix possesses a deep and diverse clinical pipeline, with its lead drug candidate, RBX2660, in Phase 3 clinical development for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 has been granted Fast Track, Orphan and Breakthrough Therapy designation from the FDA for its potential to prevent recurrent C. diff infection.

Rebiotix’s clinical pipeline also features RBX7455, a lyophilized, room temperature stable oral capsule formulation. Rebiotix is also targeting several other disease states with drug products built on its pioneering Microbiota Restoration Therapy(tm) platform. For more information on Rebiotix and its pipeline of human microbiome-directed therapies, visit https://www.rebiotix.com/

 

Highlights Of the Latest Advances In the Battle Against the Deadly Pathogen – Dale Gerding, MD

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In September, researchers, health care workers, and industry and patient advocates convened for the 4th Annual International Raising C. diff Awareness Conference and Health Expo in Atlanta.

Clifford McDonald, MD, Associate Director for Science in the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention (CDC), chaired the conference. In his role at the CDC, McDonald’s at the forefront of efforts to prevent and treat the infection – one the CDC has declared among the most urgent drug-resistant threats that we currently face.

“It’s my firm belief that we are on the threshold of a new era in better diagnosis, treatment, and prevention approaches. At the CDC, we deal with statistics, but there are faces behind those numbers. At the heart of every infection is a patient who deserves our competence, our empathy, and our passion,” said McDonald.

One of those faces, Roy Poole, is a volunteer patient advocate for the  C Diff Foundation. After retiring from a career in the Air Force, Poole led a healthy, active lifestyle as an avid outdoors-man in Colorado before antibiotics prescribed for a routine dental procedure set the stage for CDI. In the medical community, his symptoms were met with disbelief and inappropriate treatment.

“Three weeks after leaving the hospital, I walked into my (previous) primary care physician, and asked for an order to have a stool sample taken to determine if Toxins A or B were present. His response was, ‘Are you still having problems with that?’ Clearly, there is a need for more education about C. diff among physicians,” said Poole.

CDI is a formidable opponent. However, with the newly focused attention on discovering ways to disable the bacteria and cohesive public health approaches aimed at prevention, presenters from government, academia and industry offered five key reasons we can win the battle against C. diff:

Antibiotic stewardship efforts are gaining a foothold.
Statistics present a chilling picture: 453,000 new cases and an estimated 30,000 deaths each year. It’s likely that those numbers grossly underestimate the true impact of CDI, since it’s what we know from death certificate reporting.

However, we are seeing that rates may have peaked after a long plateau. Mark Wilcox, MD, Head of Microbiology at Leeds Teaching Hospital, Professor of Medical Microbiology at University of Leeds, and the lead on Clostridium difficile for Public Health England in the United Kingdom, has demonstrated a 70% reduction in cases in England in just 7 years. This was after a concerted effort that Wilcox spearheaded surrounding antibiotic stewardship, specifically addressing a reduction in unnecessary prescribing of fluoroquinolones and cephalosporin antibiotics.

Commonly prescribed antibiotics disrupt the protective microbiota (the normal bacteria of the gut) and leave it vulnerable for C. diff colonization. “There was a concerted effort that went beyond lip service and truly embraced the principles of improved surveillance, more accurate diagnostics, enhanced infection prevention measures to use antibiotics more wisely and to limit transmission and careful treatment,” said Wilcox.

High rates of CDI are always associated with the use of certain antibiotics: clindamycin, cephalosporin, and fluoroquinolones. Research has shown that lower respiratory tract infections and urinary tract infections account for more than 50% of all in-patient antibiotics use. But are these really necessary?

“We know that antibiotics are overused and misused across every healthcare setting. At least 30% of antibiotic prescriptions are unnecessary – and this equates to 47 million unnecessary antibiotic prescriptions per year written in doctors’ offices, hospital outpatient departments, and emergency departments. We have a lot of work to do, and CDC is actively working to reduce unnecessary antibiotic use,” said Arjun Srinivasan, MD at the CDC. “Stopping unnecessary antibiotics is the single most effective thing we can do to curb C. diff infections in the United States. This is something that we can do today.”

Srinivasan acknowledged that telling patients that they can’t have a prescription for an antibiotic might result in some pushback. “Patient satisfaction scores are a very real concern. When someone is sick and takes a day off work, they’re not leaving without a prescription – especially when the last provider wrote one for their same symptoms,” he said. “But this is a new day, and it’s up to the physician to educate their patients and stay strong.”

Hospitalists have access to accurate, inexpensive and quick diagnostic tests that can lead to targeted, effective treatment. This can arm the treating physician and patient with information that can put patients on a path to recovery without feeling like they are being dismissed.

Emerging guidance reflects important advances in research and development.

Most recently published in 2010, the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for C. diff are currently under review. This is critical because of the number of physicians still treating with metronidazole first, despite the fact that the largest randomized controlled clinical trial has shown that vancomycin is more effective.

“Since 2010, the landscape has changed dramatically,” said Stuart B. Johnson, MD, Professor, Department of Medicine, Loyola University, and Researcher at the Hines VA Hospital in Chicago.

“The past few years have ushered in a new age of understanding how and where C. diff colonizes, and the damaging toxins A and B that it produces.”

Considering that 25-30% of patients experience a CDI recurrence, it’s evident that metronidazole unnecessarily contributes to the failed treatment outcomes for patients. Metronidazole is less expensive, but has more side effects than oral vancomycin and is less effective in treating CDI.

Johnson provided an overview of the dramatic advances this space has seen in just the past few years.

Limitations of current guidelines include:
•       No mention of fidaxomicin, a narrow-spectrum antibiotic, which in 2011 was the first medication approved in 25 years for the treatment of C. diff associated diarrhea
•       Limited evidence for recommendations to treat severe, complicated CDI
•       Limited evidence for recommendations on recurrent CDI
•       Little mention of Fecal Microbiota Transplant (FMT)

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5.  Patient advocacy and awareness efforts can alter the course of CDI.
CDI survivors shared their experiences along their emotional journey – fear, disbelief, isolation, and depression. They also expressed gratitude at the validation, information and support they received from the patient advocacy community. Perhaps the greatest gift they have received is the empowerment to question their physicians about the necessity of antibiotics they have been prescribed in terms of risk of CDI.

“The hospital where I was treated initially seemed eager to have me leave. They offered no additional help. The C diff Foundation has been my greatest source of help. In turn, I feel I help myself cope best, when I help others to cope with the disease,” said Poole.

TO READ THIS ARTICLE IN ITS ENTIRETY AS PUBLISHED IN THE MD MAGAZINE 

PLEASE CLICK ON THE FOLLOWING LINK TO BE REDIRECTED —- THANK YOU

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Dale Gerding, MD, FACP, FIDSA, is Professor of Medicine at Loyola University Chicago, Research Physician at the Edward Hines Jr. VA Hospital. Additionally, Gerding is an infectious disease specialist and hospital epidemiologist, past president of the Society for Healthcare Epidemiology of America and past chair of the antibiotic resistance committee of SHEA. He is a fellow of the Infectious Diseases Society of America and past chair of the National and Global Public Health Committee and the Antibiotic Resistance Subcommittee of IDSA. His research interests include the epidemiology and prevention of Clostridium difficile, antimicrobial resistance, and antimicrobial distribution and kinetics.

The paper, “Burden of Clostridium difficile Infection in the United States,” was published in the New England Journal of Medicine.

The study, “Changing epidemiology of Clostridium difficile infection following the intriduction of a national ribotyping-based surveillance scheme in England,” was published in the journal Clinical Infectious Diseases.

The study, “Prevalence of antimicrobial use in US acute care hospitals,” was published in JAMA.

The paper, “Vancomycin, metronidazole, or toleyamer for Clostridium difficile infection: results from two multinaionalm randomized, controlled trials,” was published in Clinical Infectious Diseases.

The study, “A Randomized Placebo-controlled Trial of Saccharomyces boulardii in Combination with Standard Antibiotics for Clostridium difficile disease,” was published in JAMA.

Synthetic Biologics SYN-004 (ribaxamase) Achieves Primary Endpoint in Phase 2b Trial for C. difficile Infection

SyntheticBiologics2016LOGO

Synthetic Biologics’ SYN-004 (ribaxamase) Achieves Primary Endpoint
in Phase 2b Trial for C. difficile Infection (CDI)

 

Synthetic Biologics, Inc. a late-stage clinical company developing therapeutics
that preserve the microbiome to protect and restore the health of patients, today
announced positive topline data from its Phase 2b clinical trial for SYN-004 (ribaxamase),
the Company’s first-in-class oral enzyme designed to protect the gut microbiome
from disruption caused by certain intravenous (IV) beta-lactam antibiotics.

The study, a randomized, double-blind, placebo controlled trial of 412 patients, met its primary endpoint of significantly reducing C. difficile Infection (CDI). Preliminary analysis of the data indicated seven confirmed cases of CDI in the placebo group compared to two cases in the ribaxamase treatment group. Patients receiving ribaxamase achieved a 71.4% relative risk reduction (p-value=0.045) in CDI rates compared to patients receiving placebo. Adverse events reported during this trial were comparable between treatment and placebo arms.

Synthetic Biologics is also in the process of analyzing data from several exploratory endpoints that were designed to evaluate ribaxamase’s ability to protect the gut microbiome from colonization by opportunistic bacteria such as C. difficile and other antibiotic-resistant pathogens. Preliminary analysis of the data demonstrated a significant reduction in new colonization by vancomycin-resistant enterococci (VRE) for patients receiving ribaxamase compared to placebo (p-value=0.0002). With agreement from the FDA, the study included a secondary endpoint to assess ribaxamase’s capacity to decrease the incidence of antibiotic-associated diarrhea from all causes. Preliminary analysis of the data suggested a trend towards such a reduction (p-value=0.13), which was due, for the most part, to the reduction of CDI.

These data are consistent with ribaxamase’s mechanism of action designed to protect and preserve the natural balance of the gut microbiome from the unintended effects of IV antibiotic use. The Company expects to share additional results from these exploratory endpoints as they become available later this year, including results focused on ribaxamase’s ability to prevent the emergence of antimicrobial resistance in the gut microbiome.

“These trial results provide a compelling demonstration of the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome,” said Joseph Sliman, MD, SVP, Clinical and Regulatory Affairs. “More than 453,0001 patients are diagnosed with CDI annually in the U.S., resulting in approximately 29,0001 deaths as well as significant and sometimes prolonged illness. Ribaxamase has the potential to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic-resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use.”

In addition to causing significant suffering and mortality, CDI adds an estimated economic burden of nearly $1.5 billion1 to the healthcare system each year, which could potentially be reduced with an effective therapeutic.

“The reduction in the relative risk of CDI represents a significant milestone in the clinical development of ribaxamase and we believe provides further validation for our approach to advancing cutting edge microbiome science,” said Jeffrey Riley, President and Chief Executive Officer. “These findings also help further our goals to bring the first ever microbiome-focused therapeutic to patients and to help illuminate the potential of this drug class to address serious diseases and public health concerns. We expect to share additional data from exploratory endpoints in the coming months and look forward to continuing ongoing and productive discussions with both the FDA and CDC on the protocol for Phase 3 pivotal trials for ribaxamase.”

Synthetic Biologics is also continuing to prepare for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the Company’s proprietary, modified-release formulation of lovastatin lactone designed to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C).

Presentation Planned for Biotech Showcase 2017 Conference

Date: Monday, January 9, 2017
Time: 9:30 a.m. (PT) / 12:30 p.m. (ET)
Location: Hilton San Francisco Union Square, San Francisco, CA

A live webcast of Synthetic Biologics’ presentation may be accessed by logging onto the internet at https://event.webcasts.com/viewer/event.jsp?ei=1130367. After the presentation, a replay will be archived and accessible for 90 days at the same website.

About SYN-004 (ribaxamase) and the Phase 2b Study

SYN-004 (ribaxamase) is a first-in-class oral enzyme 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 the emergence of antibiotic-resistant organisms. The Phase 2b proof-of-concept clinical trial is intended to evaluate the effectiveness of ribaxamase to prevent the onset of primary C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms in patients hospitalized with a lower respiratory infection and receiving IV ceftriaxone. A total of 412 subjects were randomized in a 1:1 ratio receiving either 150 mg dose strength of SYN-004 (ribaxamase) or placebo orally QID from Day 1 and until 72 hours following their last treatment of IV ceftriaxone. The sample size was determined to provide 80% power to detect the treatment effect with a one-sided alpha of 0.05. P-values were determined based on a 1-sided z-test for the comparison of the treatment difference as pre-specified in the statistical analysis plan. To access the ribaxamase mechanism of action video on Synthetic Biologics’ website, please click here.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a late-stage clinical company developing therapeutics that preserve the microbiome to protect and restore the health of patients. The Company’s lead candidates poised for Phase 3 development are: (1) SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat an underlying cause of irritable bowel syndrome with constipation (IBS-C), and (2) SYN-004 (ribaxamase) which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. The Company is also developing preclinical stage monoclonal antibody therapies for the prevention and treatment of pertussis and novel discovery stage biotherapeutics for the treatment of phenylketonuria (PKU). For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 and include statements regarding the potential of ribaxamase to help address the serious health impacts associated with CDI and infections from other opportunistic bacteria resulting from dysbiosis of the gut microbiome, the industry data regarding the expected incidence and economic burden of CDI, the potential of ribaxamase to shorten hospital stays, diminish morbidity and mortality and reduce the emergence of antibiotic resistant organisms in the gut microbiome by protecting patients from primary C. difficile infection resulting from IV antibiotic use, the potential to reduce the economic burden to the healthcare system from an effective therapeutic, the suggested trend toward a reduction of incidence of antibiotic-associated diarrhea from all causes, the expected timing of data release of exploratory endpoints of the trial focused on the ability of ribaxamase to prevent the emergence of antibiotic-resistant organisms in the gut microbiome, the continued ongoing discussions with the FDA and CDC, validation for our approach to advancing cutting edge microbiome science, the continued preparation  for the initiation of pivotal Phase 2b/3 clinical trials for SYN-010, the potential of the drug class to address serious diseases and public health concerns, the ability of SYN-004 to protect the gut microbiome from the effects of certain commonly used IV beta-lactam antibiotics for the prevention of  C. difficile infection, antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of 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 current expectations include, among others, Synthetic Biologics’ product candidates demonstrating safety and effectiveness, as well as results that are consistent with prior results, Synthetic Biologics’ ability to initiate clinical trials and if initiated, to complete them on time and achieve desired results and benefits, Synthetic Biologics’ clinical trials continuing enrollment as expected, Synthetic Biologics’ ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, regulatory limitations relating to Synthetic Biologics’ ability to promote or commercialize its product candidates for specific indications, acceptance of its product candidates in the marketplace and the successful development, marketing or sale of Synthetic Biologics’ products by competitors that render Synthetic Biologics’ products obsolete or non-competitive, Synthetic Biologics’ ability to maintain its license agreements, the continued maintenance and growth of Synthetic Biologics’ patent estate, Synthetic Biologics becoming and remaining profitable, Synthetic Biologics’ ability to establish and maintain collaborations, Synthetic Biologics’ ability to obtain or maintain the capital or grants necessary to fund its research and development activities, a loss of any of Synthetic Biologics’ key scientists or management personnel, and other factors described in Synthetic Biologics’ Annual Report on Form 10-K for the year ended December 31, 2015 and its other filings with the SEC, including subsequent periodic reports on Forms 10-Q and 8-K.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.

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

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/synthetic-biologics-syn-004-ribaxamase-achieves-primary-endpoint-in-phase-2b-trial-for-c-difficile-infection-cdi-300386140.html

SOURCE Synthetic Biologics, Inc.

Fecal Microbiota Transplantation (FMT) A Promising Treatment And Recurrent C diff Infections

NurseCadeceus

The media and publications are raising
FMT awareness .

The positive effects are being
noted as FMT’s hold a promising treatment option and success is being witnessed in patients suffering
through C. diff. infections.

Being treated  by a physician with a Fecal Microbiota Transplantation, to treat recurrent Clostridium difficile infections, is resolving the pain and torment being experienced by patients.

What is a Fecal Microbiota Transplant (FMT)?

Fecal microbiota transplants (FMTs) are exactly what they sound like.
They involve taking feces from a healthy person and putting them into the body
of a sick patient to strengthen the community of bacteria that live in the patient’s gut.
FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff).

The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome. (1)

However; this treatment – in any form – has not yet been approved by the
U.S. Food and Drug Administration (FDA).

Clinical data is pending and FMT remains investigational at this time.

Below is the link to the FDA website and the March 2014 document regarding
Fecal Microbiota Transplantation (FMT) for the general public:

III.  When FDA Intends to Exercise Enforcement Discretion 

FDA does not intend to exercise enforcement discretion for the use of an FMT product when the FMT product is manufactured from the stool of a donor who is not known by either the patient or the licensed health care provider treating the patient, or when the donor and donor stool are not qualified under the direction of the treating licensed health care provider.
FDA will continue to evaluate its enforcement policy.
Furthermore, during the period of enforcement discretion, FDA will continue to work with sponsors who intend to submit INDs for use of FMT to treat C. difficile infection not responding to standard therapies.
This enforcement discretion policy does not extend to other uses of FMT.  Data related to the use and study of FMT to treat diseases or conditions other than C. difficile infection are  more limited, and study of FMT for these other uses is not included in this enforcement policy.  (2)
* Also, click on the link below to view the US Food and Drug Administration (FDA)
Upcoming Workshop Information:
**  Always discuss treatment options available with a Healthcare provider
and review/discuss clinical studies in progress.
Resources:

Trinity Guardion Bed Protection System Proven To Reduce C. diff., A Healthcare-Associated Infection, By 50%

NewspaperII IN THE NEWS………….

Trinity Guardion was selected by Xavier University’s Center for Innovation to present their Bed Protection System, which is proven to reduce a Hospital Acquired C.diff infection by 50%, at Healthovate! Summit on Thursday, June 11. The 2015

Xavier Center for Innovation (CFI) Healthovate! Summit is co-sponsored by Intel-GE Care Innovations™. “Trinity Guardion is the world’s only manufacturer of launderable bed covers specifically engineered to eliminate bacteria, spores and viruses from a hospital bed mattress. I’m excited to present this patented technology with over 6 years of research behind it to this esteemed group of innovators,” states Bruce Rippe, Trinity Guardion’s Chief Operating Officer.

Healthovate! Summits give healthcare leaders an opportunity to share their expertise and engage in conversations with other leaders from other industries. Trinity Guardion will also be presenting at similar events in Boston (July 31), Chicago (Oct 5), and Nashville (Oct 28). “Our mission at the CFI is to use innovation to solve complex problems. I can’t think of a more important challenge facing our society than how we keep people healthy, while reducing costs and improving overall well-being,” said Shawn Nason, Chief Innovation Officer at Xavier University. “By bringing together a diverse community of people, all committed to health, I am confident we can find meaningful solutions and innovative technologies and systems that will transform the healthcare industry—not to mention better ways to educate and prepare students to work in and lead healthcare in the future.”

Over 40 area start-up hospitals, universities, national organizations, healthcare professionals, and Xavier alumni will learn how this innovative mattress cover acts as a barrier to prevent bacteria and fluids, which can be harbored in a hospital mattress as a result of ineffective cleaning, from coming in contact with a patient. Due to its abilities in preventing viruses such as Ebola and other bacteria from penetrating through the cover, hospitals have begun to implement the covers in their infection control wards. Last year, the innovative technology of the Trinity Bed Protection System was recognized when the honorable mention for the 2014 NALTH Goldberg Innovation Award was awarded to St. Vincent Seton Specialty Hospital, Indianapolis for their use of the mattress cover in their facility.

Tested in two Midwestern hospitals, the Trinity Bed Protection System does not impede bed operation or any clinical aspects of the underlying mattress. In fact, it helps reduce terminal clean time, while improving asset life of the bed.

The Trinity Bed Protection System from Trinity Guardion makes bed surfaces cleaner for every person every time.

About Trinity Guardion: Trinity Guardion is the result of an international collaboration of scientists, doctors and academic professionals in the healthcare industry, united in the concern that hospital beds are not clean. This concern was corroborated by peer reviewed research that is available upon request. The product line includes mattress covers for most brands of hospital beds, therapy tables and pillow cases.

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.

 

Clostridium difficile Biologic Research and Development; May 2014

laboratorystill

 

 

 

Clostridium difficile Biologic Research & Development

Antibiotic administration is a risk factor for Clostridium difficile-associated disease (CDAD).

Excretion of antibiotics into the intestinal tract may lead to an alteration of the normal microflora, resulting in overgrowth of pathogenic bacteria including Clostridium difficile.       Stiefel, et al. have previously reported that oral administration of β-lactamase enzyme inactivates ampicillin and piperacillin in the small intestine. This study evaluates oral β-lactamase administration in combination with parenteral piperacillin or ampicillin in mice to validate the hypothesis that oral β-lactamase protects the microbiota and prevents          Clostridium difficile infection (CDI).
http://jac.oxfordjournals.org/content/62/5/1105.full.pdf+html

 

Brian Andresen, Chairperson of Biologic Research and Development Committee   (*)              *Michael Kaleko, MD, PhD, Senior Vice President, Reseaerch & Development Synthetic Biologics  *Joseph Sliman, MD, MPH, Senior Vice President, Clinical & Regulatory Affairs, Synthetic Biolgics *Andy Bristol, PhD, Vice President, Research & Development, Synthetic Biologics                   *Lewis Barrett, Senior Vice President, Commercial Strategy, Synthetic Biologics