Tag Archives: C difficile treatment clinical study

Fight C. diff. With A Non-Toxic Strain Of C. diff

In The News:

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Dale Gerding, M.D., a professor of medicine at Loyola University’s Stritch School of Medicine in Chicago says, “Antibiotics disrupt your normal microbiota and when they do that they enable you to be susceptible to C. diff.”

Even after treatment, C. diff comes back in 20 percent of patients.

O’Riordan had it six times in less than a year.

Dr. Gerding has patented a novel treatment to prevent recurrence by giving patients a non-toxic strain of C. diff.

“Instead of replacing the microbiota, which is what a fecal transplant does, all this does is replace the C. Diff,” explains Dr. Gerding

Stuart Johnson, M.D., an infectious disease physician and professor of medicine at Loyola University’s Stritch School of Medicine says, “You can think of it as a probiotic, we like to think of it as a bio-therapeutic.”

They believe a non-toxic strain of C. diff could be the answer to protecting hundreds of thousands of people against the fastest growing superbug.

“I don’t want to go through this again, ever. Ever! Anything even remotely like that,” says O’Riordan.

Dr. Gerding said the non-toxic strain of C. diff doesn’t have any serious side effects, and it stays in the body for up to five months, which is why it cut the recurrence rate to two percent in studies.

Dr. Gerding is currently looking for a company to develop the treatment. It would be given in pill or liquid form.

For article in its entirety please click on the link below:

http://www.wtvm.com/story/32162456/fighting-c-diff-with-c-diff

MODIFY Trials Showed That Taking bezlotoxumab (Merck), a Monoclonal Antibody That Neutralizes Clostridium difficile Toxin B, Led To Lower Recurrence of C. difficile Infection and Fewer Hospital Re-admissions

In The News

A post hoc and subpopulation analysis of the MODIFY trials showed that taking bezlotoxumab (MERCK) , a monoclonal antibody that neutralizes Clostridium difficile toxin B, led to lower recurrence of C. difficile infection and fewer hospital readmissions among European patients compared with placebo, according to study data presented at ECCMID 2016.

MODIFY I and II were global phase 3 trials that demonstrated the safety and efficacy of a single 10 mg/kg IV dose of bezlotoxumab (Merck) to decrease C. difficile recurrence when paired with standard antibiotic therapy. While initial antibiotic treatment for C. difficile is often successful, up to 35% of patients experience a recurrence of the infection, with each recurrence increasing the risk for future recurrences.

In the post hoc analysis, researchers studied a subset of European patients from the MODIFY trials who received standard antibiotic treatment plus either bezlotoxumab (n = 313) or placebo (n = 293).

Analysis showed that the recurrence of C. difficile in the bezlotoxumab group was 15% vs. 24.2% in the placebo group (difference, –9.2%; 95% CI, –15.6 to –2.9). These rates were consistent with those observed in the overall group of patients in the MODIFY trials, according to the researchers. Further, just 4.5% of European patients in the bezlotoxumab group experienced hospital readmission associated with C. difficile infection compared with 13.3% in the placebo group (difference, –8.8%; 95% CI, –13.9 to –4). All-cause hospital readmissions were 23% in the bezlotoxumab group and 26.6% in the placebo group (difference, –3.5%; 95% CI –11 to 3.9).

Results of two other post hoc analyses of the MODIFY trials also were presented at ECCMID 2016.

In one, researchers showed that giving bezlotoxumab to patients receiving standard antibiotic care was effective through 12 weeks in key subpopulations at high risk for C. difficile recurrence and/or C. difficile infection-related adverse outcomes, including those aged 65 years and older, those with at least one C. difficile infection within the previous 6 months, and those who were immunocompromised.

Another post hoc analysis showed that the magnitude of reduction in rates of C. difficile recurrence in patients taking bezlotoxumab compared with placebo was greater when diagnosis was made using enzyme immunoassays for toxin detection (–12.8%; 95% CI –18.5 to –7) rather than PCR (–6.5%; 95% CI –12.8 to –0.3). The results were clinically meaningful no matter the testing method, the researchers said. – by Gerard Gallagher

To read full article click on the following link:

http://www.healio.com/infectious-disease/gastrointestinal-infections/news/online/%7B2c78b819-6147-45a8-b615-aee90fc4d5ce%7D/bezlotoxumab-helps-to-reduce-cdi-recurrence-hospital-readmissions

 

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

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.

Researchers At Kingston General Hospital (Canada) Have Developed A Synthetic Alternative To Fecal Transplants

In the news…………..

It’s one of the most common infections patients can get while receiving care at a health care facility. C-difficile outbreaks in hospitals can be problematic and expensive to deal with. They can also be potentially lethal for anyone contracting the bacteria.

Dr. Gerald Evans is the head of infectious diseases at KGH. He says the hospital hasn’t had a C-Difficile outbreak since 2012 and KGH has one of the best disease and infection control records in the province.

“We’re seeing C-Diff less in hospitals but we are seeing more Clostridium Difficile infections arising in the community.”

Recurrent C-Diff becomes a challenge and part of what Dr. Petrof’s research work is about, is actually, being able to treat those people successfully.”

One way of treating someone with C-Difficile is through a fecal transplant. The healthy stool reintroduces the good bacteria the body needs in the bowel.

“This is what we call the robo-gut it’s a anaerobic hemostat and we can grow microbial communities in here.”

And it’s in that mechanical gut that  Dr. Elaine Petrof and her team of researcher’s have developed a synthetic alternative to fecal transplants called “Repoopulate”.

“We took a healthy donor and we isolated the bacteria from the stool of that healthy donor and pulled out the good bacteria or the ones that we thought would be beneficial to use in the transplant.”

“Funding from the National Institute of Health will allow Dr. Petrof’s team to continue their human clinical trials and prove what they believe.

That the synthetic repoopulate is safer and more effective. ”

“We think that it will be safer you know just because you know what you’re dealing with. There’s no danger of pathogens, viruses and things like that being mixed in.”

*patient safety *

Petrof says if their research progresses as expected “Repoopulate” could be approved for use in about a years time.

 

Sourece: Darryn Davis CKWS Newswatch Kingston

http://www.ckwstv.com/2016/01/25/researchers-at-kgh-are-developing-a-new-therapy-to-treat-c-difficile/

  • * C Diff Foundation Notation

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