Tag Archives: Microbiome

C.difficile (C.diff.) Infections Continue to Grow in Health Care Facilities Worldwide

The burden of Clostridium difficile (C. diff) continues to grow in health care facilities throughout the United States and around the world.

Gaining a better understanding of sources and risk factors for C. diff can help reverse colonization and transmission or prevent it altogether, authors of a new paper suggest.

To view the article in its entirety, please click on the following link to be redirected:

http://www.contagionlive.com/news/exploring-microbiome-changes-associated-with-c-diff-to-prevent-or-reverse-colonization

“This is a review/commentary article that provides a high-level overview of the literature dealing with C. diff colonization and the microbiome changes associated with C. diff colonization,” author Silvia Munoz-Price, MD, PhD, from the Medical College of Wisconsin in Milwaukee told our sister publication MD Magazine.

After reviewing the literature, authors of the study postulated that when it comes to the potential for C. diff colonization, exposure to and transmissions of the virus occurs outside of hospitals. In fact, it seemed like most of the patients became symptomatic during their hospital stay, rather than acquiring the virus while hospitalized.

For example, the investigators cited one study from Canada that had been conducted from 2006 to 2007 where more than 4000 patients were screened for C. diff colonization upon hospitalization, during their stay (on a weekly basis) and at discharge. They found that 4% of the patients were colonized upon hospitalization and 3% acquired C. diff during their stay in the hospital.

The authors also found evidence indicating that community-acquired C. diff appears to be on the rise. The authors discuss a decade-long study which took place in Minnesota where community-acquired C. diff infection rates rose from 2.8 to 14.9 per 100,000-person-years within the 10-year span. The patients in that study more likely to acquire C. diff were younger, female, and healthier than patients with hospitalization acquired C. diff. The reviewers also said that rates of community-acquired C. diff have also been rising in Finland, Australia, and England, according to published studies.

Most of the common risk factors for community-acquired C. diff infections still applied, the researchers found, including antibiotic exposure, household contact, and animals. A 2013 study showed that two-thirds of community-acquired C. difficile patients were exposed to antibiotics in the preceding 12 weeks of their infection, and about one-third had been exposed to proton pump inhibitors.

While studies examining transmissibility within households are difficult to come by, the study authors found one review from Quebec. The review consisted of 2222 cases of C. diff diagnosed between 1998 and 2009, and investigators found that 8 cases were designated to be transmitted by household contacts. However, the researchers noted, confirmation using strain typing was not performed in that study.

Looking at farm livestock, a 2013 Dutch study showed that individuals with daily contact with pigs showed rates of C. diff positivity of 25%; in those with weekly contact, it was 14%. In the same study, C. diff was found in the manure from all the farms in 10% to 80% of the samples per farm. The reviewers also said that C. diff has been found in the stool of farm chickens, calves, and retail ground meat. Dogs and cats are also known to culture positive for C. diff, and the researchers wrote that the bacteria can also be present in vegetables and water (tap water, swimming pools, as well as rivers, lakes, and seas). They hypothesized that the presence of C. diff in vegetables may come from the use of organic fertilizer.

“We envision that in the future we should be able to take advantage of our increasing knowledge about microbiome changes so that we will be able to: identify patients at risk for de novo C. difficile colonization during their hospitalization and manipulate our patients’ microbiome to prevent or reverse C. difficile colonization,” Dr. Munoz-Price said.

“Different from what we do now, the latter would be accomplished not by withholding or changing antibiotics but by correcting the deficient flora of a patient in an individualized fashion. This new approach would revolutionize the field of Infection Control and Antibiotic Stewardship,” she concluded.

David Kirk and Ben Bradley Explain the Gut Microbiome and Clostridium difficile

It has access to the largest surface area of the body, alters drugs before they even enter the blood stream and could be a potent medicinal weapon… yet there is much we still don’t understand about the microbiome.

Here David Kirk and Ben Bradley tell us about their attempts to heal us from within

We are not alone. We are inhabited by hundreds of species of microbes, which represent millions of genes. Together, these microscopic organisms – bacteria, fungi, archaea and viruses ­– and their collective genomes make up the microbiome.

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

https://www.labnews.co.uk/interviews/guestbook/therapeutics-live-21-05-2018/

In the gut, microbes break down otherwise indigestible dietary fibres and release nutrients, such as B-vitamins and short chain fatty acids, which can be absorbed by the intestines. They secrete other small molecules or peptides which interact with the body via the bloodstream and immune system. The majority of these have yet to be identified and characterised. In addition, commensal microbes deter opportunistic pathogens from invading the competitive niche of the intestinal tract.

LBPs are a recent concept and have their origins in a novel treatment for C. difficile infection: the faecal microbiota transplant… this is exactly what you think it is

The disruption of the microbiome, termed dysbiosis, is associated with an ever-growing list of conditions. Obesity and metabolic syndrome, for instance, are associated with a microbiome less diverse than that of a healthy individual. Inflammatory bowel disease (IBD) and colorectal cancer are associated with a decrease in butyrate-producing bacteria like Clostridia, and an increase in Enterobacteriaceae and Bacilli.

An air of scepticism comes with the phrase “associated”. Microbiome research is still a developing field, and the presence or absence of a single species or genus cannot be directly blamed for conditions like obesity or IBD in all patients. The complex interplay between host and microbiome depends as much on the host’s genetic susceptibility and environment as on the dysbiosis or lack of diversity in the microbiome. The million dollar question remains: What exactly constitutes a ‘healthy microbiome’?

A powerful tool
The microbiome is adaptive and changes in response to diet, environment and disease. It has become increasingly clear that many drugs interact with the microbiome, with some requiring microbiota derived enzymes for activation and others being rendered non-functional or even toxic via microbiota dependant conversion. As research in host-microbe interaction continues, more accurate relationships between the microbiome and human illness will be uncovered.

The gut microbiome presents an interesting medicinal target in itself. It interacts directly with one of the largest surface areas of the body. Therefore it has easy access to the bloodstream through diffusion of nutrients and small molecules, and via a mucosal layer rich in multiple cell types of the adaptive and innate immune systems. Due to the powerful delivering capacity of the gut, most microbial-based treatments in development aim to add to the microbiome rather than take away from it.

Microbial therapies using living organisms are known as live biotherapeutic products (LBPs). LBPs are a recent concept and have their origins in a novel treatment for C. difficile infection (CDI): the faecal microbiota transplant.

This is exactly what you think it is.

CDI occurs when the gut microbiome is wiped out by antibiotic use and becomes infected by C. difficile, an organism that is normally unable to compete against the natural microbiota. This illness may recur in spite of further antibiotic treatments, and can be fatal. The most effective treatment, in extreme cases, is a faecal transplant into the infected recipient. Transplanted microbes thrive and outcompete C. difficile, effectively reversing the infection in over 90% of cases. But due to the uncertainty of what constitutes a ‘healthy microbiome’, a faecal transplant cannot be considered a cure-all for dysbiosis-associated illness.

Daunting clinical trials
This “unknown” of host-microbe interaction sparked the need to develop defined microbiome therapies. Naturally, CDI was one of the first targets for a defined treatment. Several companies are developing and trialling defined cocktails of bacteria known to safely inhabit the gut with the goal of outcompeting C. difficile with Seres Therapeutics and Rebiotix entering phase 3 trials in 2018.

CHAIN Biotech is developing technology to deliver therapeutics to the gut microbiome using engineered Clostridium, a spore forming bacterium, and have a lead candidate targeting IBD. IBD is a collection of inflammatory diseases of the gut, commonly treated with steroid injections which cause numerous unpleasant side effects. Our approach is to deliver an LBP directly to the gut, where it can produce an anti-inflammatory in situ. We also make use of this species’ natural ability to produce spores, which survive the acidic environment of the stomach and germinates into therapeutic-producing cells only in the anaerobic environment of the lower intestine.

This elementary approach – adding one organism with a safe history of use in the human gut, and having it produce one novel product – minimizes the risk of disruption to the microbiome and delivers the treatment directly to the affected area. The next stages, taking LBPs to clinical trial, are daunting. A lot of unknowns exist around the human gut microbiome and these kinds of treatments. Few microbiome companies have LBPs in late-stage clinical trial, but those that do give hope to both patients and us that LBPs will someday heal us from within.

Minnesota Has Declared November “C. difficile Infection Awareness Month

 

 

 

 

http://www.clipsyndicate.com/video/play/7172019

According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

The state of Minnesota has declared November C. difficile Infection Awareness Month.” According to research, C. Diff is the most common infection in U.S. hospitals within the last decade.

Doctors at Mayo Clinic want people to know that they can get the infection even outside of hospitals. They also say once you get it, it’s easier to get it each time.

Dr. Sahil Khanna said ways to prevent C. diff is to wash hands and avoid unnecessary antibiotics.

He said Mayo Clinic is also studying whether or not there could be a vaccination for C. Diff.

“So there’s a large multi-center study that’s going on right now in people who may be at risk for C. Diff infection,” Khanna said. “So if you’ve been to the hospital, if you’ve received antibiotics, those patients can be enrolled in a vaccine study to see if this vaccine would prevent C. Diff from happening.”

Mayo Clinic is also working with Minnesota-based company Rebiotix on another form of treatment for the infection where people can simply ingest a tablet.

“Newer studies are being derived where you can actually take material from donor stool, process donor stool in a lab, and derive all the good bacteria that you need from the donor stool and put them in capsule form,” Khanna said.

Khanna said this capsule-based treatment has more advantages than a colonoscopy-based treatment that is currently being used to treat C. Diff.

 

Clifford McDonald, MD and Alison Laufer-Halpin, Ph.D., of the CDC Discuss the Human Microbiome on C. diff. Spores and More

C Diff Foundation’s “C. diff. Spores and More Global Broadcasting Network” is honored to announce Doctors McDonald and Laufer-Halpin as our guest speakers on

Tuesday, July 25, 2017 at 10 a.m. PT / 1 p.m. ET

(www.cdiffradio.com)

These two leading topic experts will be discussing significant ways to unlock the mysteries of the human microbiome; how it affects our health, the immune system, and why it is so important to protect it.

As part of the Centers for Disease Control and Prevention (CDC) efforts to protect patients and slow antibiotic-resistance, the CDC is investing in research to discover and develop new ways to prevent antibiotic-resistant infections.

To Listen To the Podcast – click on the following link:

https://www.voiceamerica.com/episode/100322/the-human-microbiome-how-it-works-how-it-affects-your-health-your-immune-system-and-why-it-is

 

Learn more about C Diff Radio at: http://www.cdiffradio.com/.

Study shows Microbiome Differences Between Intensive Care Unit Patients Hospitalized From Healthy Patients

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The microbiome of patients admitted to the intensive care unit (ICU) at a hospital differs dramatically from that of healthy patients, according to a new study published in mSphere.

 

Researchers analyzing microbial taxa in ICU patients’ guts, mouth and skin reported finding dysbiosis, or a bacterial imbalance, that worsened during a patient’s stay in the hospital. Compared to healthy people, ICU patients had depleted populations of commensal, health-promoting microbes and higher counts of bacterial taxa with pathogenic strains – leaving patients vulnerable to hospital-acquired infections that may lead to sepsis, organ failure and potentially death.

What is dysbiosis?  Pathogens, antibiotic use, diet, inflammation, and other forces can cause dysbiosis, a disruption in these microbial ecosystems that can lead to or perpetuate disease  (1)

What makes a gut microbiome healthy or not remains poorly defined in the field. Nonetheless, researchers suspect that critical illness requiring a stay in the ICU is associated with the the loss of bacteria that help keep a person healthy. The new study, which prospectively monitored and tracked changes in bacterial makeup, delivers evidence for that hypothesis.
“The results were what we feared them to be,” says study leader Paul Wischmeyer, an anesthesiologist at the University of Colorado School of Medicine. “We saw a massive depletion of normal, health-promoting species.”
Wischmeyer, who will move to Duke University in the fall, runs a lab that focuses on nutrition-related interventions to improve outcomes for critically ill patients.

He notes that treatments used in the ICU – including courses of powerful antibiotics, medicines to sustain blood pressure, and lack of nutrition – can reduce the population of known healthy bacteria. An understanding of how those changes affect patient outcomes could guide the development of targeted interventions to restore bacterial balance, which in turn could reduce the risk of infection by dangerous pathogens.
Previous studies have tracked microbiome changes in individual or small numbers of critically ill patients, but Wischmeyer and his collaborators analyzed skin, stool, and oral samples from 115 ICU patients across four hospitals in the United States and Canada. They analyzed bacterial populations in the samples twice – once 48 hours after admission, and again after 10 days in the ICU (or when the patient was discharged). They also recorded what the patients ate, what treatments patients received, and what infections patients incurred.
The researchers compared their data to data collected from a healthy subset of people who participated in the American Gut project dataset. (American Gut is a crowd-sourced project aimed at characterizing the human microbiome by the Rob Knight Lab at the University of California San Diego.) They reported that samples from ICU patients showed lower levels of Firmicutes and Bacteroidetes bacteria, two of the largest groups of microbes in the gut, and higher abundances of Proteobacteria, which include many pathogens.
Wischmeyer was surprised by how quickly the microbiome changed in the patients. “We saw the rapid rise of organisms clearly associated with disease,” he says. “In some cases, those organisms became 95 percent of the entire gut flora – all made up of one pathogenic taxa – within days of admission to the ICU. That was really striking.” Notably, the researchers reported that some of the patient microbiomes, even at the time of admission, resembled the microbiomes of corpses. “That happened in more people than we would like to have seen,” he says.
Wischmeyer suggests the microbiome could be tracked like other vital signs and could potentially be used to identify patient problems and risks before they become symptomatic. In addition, now that researchers have begun to understand how the microbiome changes in the ICU, Wischmeyer says the next step is to use the data to identify therapies – perhaps including probiotics – to restore a healthy bacterial balance to patients.
Everyone who collaborated on the project – including dietitians, pharmacists, statisticians, critical care physicians, and computer scientists – participated on a largely voluntary basis without significant funding to explore the role of the microbiome in ICU medicine, says Wischmeyer.

 

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

https://www.asm.org/index.php/journal-press-releases/94540-icu-patients-lose-helpful-gut-bacteria-within-days-of-hospital-admission?platform=hootsuite

Sources:

(1)  http://www.serestherapeutics.com

 

Thanks and Appreciation To Our Guests For Joining Us On C. diff. Spores And More Season II

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As Season II concludes, we wish to take this opportunity to sincerely thank each
and every guest for taking time out of their
busy schedule and joining us on Tuesday’s at
10:00a Pacific Time / 1:00p Eastern Time over the past seven months.

C. diff. Spores and More Global Broadcasting Network will be taking a break and will return to live broadcasting on  January 17th, 2017 with the Centers for Disease Control and Prevention (CDC) leading the way with our guest
Dr. Katherine Fleming-Dutra, Medical Officer, CDC’s Office of Antibiotic Stewardship.

A Prescription for Over-Prescribing: The Key to Fighting
Antibiotic Resistance

Dr. Fleming-Dutra is a medical epidemiologist with the Office of Antibiotic Stewardship in the Division of Healthcare Quality Promotion at the Centers Disease Control and Prevention (CDC).

Dr. Fleming-Dutra is a pediatrician and pediatric emergency medicine physician and has focused on infectious diseases epidemiology and antibiotic stewardship in the outpatient setting in her career at CDC.

Join Dr. Fleming-Dutra as she discusses a recent study published by the Journal of the American Medical Association, was released showing that at least 30 percent of all prescriptions written in doctors’ offices and emergency rooms are completely unnecessary. So how do we use these alarming results to transform the culture of over-prescribing Dr. Katherine Fleming-Dutra, M.D., will:

  • Give a detailed explanation of the study results, and provide an in-depth review of specific findings;
  • Highlight what CDC is doing to promote antibiotic stewardship across healthcare settings, and
  • Identify what clinicians, other health care professionals, and patients can do to improve antibiotic prescribing, therefore fighting antibiotic resistance.

 

C diff Radio™ Live Broadcast AND Podcasts

cdiffRadioLogoMarch2015C. diff. Spores and More Global Broadcasting Network™

  brought to you by VoiceAmerica and
sponsored by Clorox Healthcare

An educational program that is dedicated to  C. difficile Infections  and more–

 

Click On The LOGO  Above And Enjoy Listening To the Live Broadcasts In the C. diff. Spores and More Podcast Library.

 

Live Broadcast airs
on Tuesdays at:    10a PT,    11a MT,   12p CT,    1p ET

We are pleased to share  “C. diff. Spores and More ™”  with you because, as advocates of  C. diff.,  we know the importance of this cutting-edge new weekly radio show  and what it means for our Foundation’s community worldwide.–

Hard Facts: Deaths and illnesses are much higher than reports have shown. Nearly half a million Americans suffered from Clostridium difficile (C. diff.) infections in a single year according to a study released today, February 25, 2015, by the Centers for Disease Control and Prevention (CDC).

• More than 100,000 of these infections developed among residents of U.S. nursing homes.

Approximately 29,000 patients died within 30 days of the initial diagnosis of a C. diff. infection. Of these 29,000 – 15,000 deaths were estimated to be directly related to a
C. diff. infection. Therefore; C. diff. is an important cause of infectious disease death in the U.S.

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Previous studies indicate that C. diff. has become the most common microbial cause of Healthcare-Associated Infections found in U.S. hospitals driving up costs to $4.8 billion each year in excess health care costs in acute care facilities alone. Approximately
two-thirds of C. diff. infections were found to be associated with an inpatient stay in a health care facility, only 24% of the total cases occurred in patients while they were hospitalized. The study also revealed that almost as many cases occurred in nursing homes as in hospitals and the remainder of individuals acquired the
Healthcare-Associated infection, C. diff., recently discharged from a health care facility.

This new study finds that 1 out of every 5 patients with the Healthcare-Associated Infection (HAI), C. diff., experience a recurrence of the infection and 1 out of every 9 patients over the age of 65 diagnosed with a HAI – C. diff. infection died within 30 days of being diagnosed. Older Americans are quite vulnerable to this life-threatening diarrhea infection. The CDC study also found that women and Caucasian individuals are at an increased risk of acquiring a C. diff. infection. The CDC Director, Dr. Tom Frieden, MD, MPH said, “C. difficile infections cause immense suffering and death for thousands of Americans each year.” “These infections can be prevented by improving antibiotic prescribing and by improving infection control in the health care system. CDC hopes to ramp up prevention of this deadly infection by supporting State Antibiotic Resistance Prevention Programs in all 50 states.”

“This does not include the number of C. diff. infections taking place and being treated in other countries.”  “The  C Diff Foundation supports hundreds of communities by sharing the Foundation’s mission and  raising C. diff. awareness to healthcare professionals, individuals, patients, families,  and communities working towards a shared goal ~  witnessing a reduction of newly diagnosed C. diff. cases by 2020 .”   ” The C Diff Foundation volunteer Advocates are greatly appreciated and continue to create positive changes by sharing their time  aiding in the success of our mission “Raising C. diff. awareness ™”  worldwide.

C. diff. Spores and More ™“ spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives, C. diff. survivors, board members, and their volunteers who are all creating positive changes in the
C. diff.
community and more.

Through their interviews, the C Diff Foundation mission will connect, educate, and empower listeners worldwide.

Questions received through the show page portal will be reviewed and addressed  by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP,  Dr. Fred Zar is a Professor of Clinical Medicine, Vice HeZarPhotoWebsiteTop (2)ad for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago.  Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.

 

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Programming for C. diff. Spores and More ™ is made possible through our official Corporate Sponsor;  Clorox Healthcare

We look forward to sharing time with our worldwide listeners when we return in January, Season III. 

Until then………………

We send out get-well wishes to everyone being treated for and recovering from a C. difficile infection and all wellness draining illnesses worldwide.

“None of us can do this alone – All of us can do this together!”

Summit Therapeutics Announces Additional Positive Data From the CoDIFy Phase 2 Clinical Trial That Show Narrow Spectrum Antibiotic ridinilazole Preserves Gut Microbiome in C.diff. Infection Patients

In The News *

Summit Therapeutics , the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces additional positive data from the CoDIFy Phase 2 clinical trial that show the narrow spectrum antibiotic ridinilazole preserves the gut microbiome in CDI patients while the standard of care, vancomycin, inflicts substantial and long-lasting damage on the gut microbiome.

About Ridinilazole
Ridinilazole (SMT19969) is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy.  Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track status by the US Food and Drug Administration.  The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

“CDI results from damage to the microbiome, and patients experience further collateral damage through the use of broad spectrum antibiotics to treat CDI, leaving them vulnerable to recurrent disease,” commented David R. Snydman, MD, FACP, FIDSA, Chief, Division of Geographic Medicine and Infectious Diseases and Hospital Epidemiologist of Tufts University School of Medicine. “New, selective antibiotics are needed to minimise these high recurrence rates, and ridinilazole demonstrates an exceptional ability to preserve a patient’s microbiome and allow the growth of protective bacteria, which are vital to protecting against CDI.”

Preliminary analysis of these new data show ridinilazole to be highly preserving of the gut microbiome. Ridinilazole treated patients in CoDIFy exhibited no further damage to their microbiome during therapy with a proportion of patients showing initial evidence of recovery of key bacterial groups with roles in protecting from CDI. In stark contrast, vancomycin treated patients suffered substantial damage to their gut microbiome during treatment and this persisted in many patients during the 30-day post treatment period.

“These new results from the Phase 2 trial show ridinilazole preserves the patients’ microbiome while simultaneously working to eradicate the C. difficile bacteria. The clinical data strongly suggest that ridinilazole treatment may be better able to protect against recurrent disease than the current standard of care,” commented Glyn Edwards, Chief Executive Officer of Summit Therapeutics. “We believe this approach offers a clear advantage over conventional broad spectrum antibiotics currently used to treat CDI that cause substantial damage to the gut microbiome or approaches that aim to artificially re-establish a damaged gut microbiome following antibiotic treatment.”

“As evidenced by our growing body of clinical and preclinical data, we believe ridinilazole has the ideal profile to become a single therapeutic approach capable of both treating the initial infection and reducing the high rates of recurrent disease.”

These key microbiome findings strongly support recently reported results from the Phase 2 CoDIFy trial that showed ridinilazole to be statistically superior to vancomycin in sustained clinical response (‘SCR’), a combined endpoint capturing both initial cure and rates of recurrent CDI, with the improved SCR rate following ridinilazole treatment being driven by a large numerical reduction in recurrence. Full microbiome data are expected to be published at a scientific conference in due course.

About CoDIFy
CoDIFy was a double blind, randomized, active controlled, multi-centre, Phase 2 clinical trial that evaluated the efficacy of ridinilazole against vancomycin in a total of 100 patients. Half of the patients received ridinilazole for ten days (200 mg, twice a day), and the remaining half received vancomycin for ten days (125 mg, four times a day). The results of the trial showed ridinilazole achieved statistical superiority in SCR with rates of 66.7% compared to 42.4% for vancomycin.  SCR is defined as cure at the end of therapy and no recurrent disease 30 days post end of therapy. The primary analysis was conducted on the modified intent-to-treat (‘mITT’) population that comprised subjects with CDI confirmed by the presence of free toxin. These additional data on the preserving effect ridinilazole had on the gut microbiome support the top-line Phase 2 data and improvement observed in rates of recurrent disease.

 

About Ridinilazole
Ridinilazole (SMT19969) is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response (‘SCR’) rates compared to the standard of care, vancomycin. In this trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy.  Ridinilazole has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track status by the US Food and Drug Administration.  The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection.

Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

To read the article in its entirety:

http://www.econotimes.com/Summit-Announces-Ridinilazole-Preserves-the-Gut-Microbiome-of-Patients-With-C-difficile-Infection-in-Phase-2-Trial-173750

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