Tag Archives: C. difficile clinical trials

Learn More About Clostridium difficile (C.diff., C.difficile) infection and Recurrent CDI Clinical Trials In Progress

 

 

 

The C Diff Foundation has implemented a global campaign to raise awareness of Clostridium difficile infection (C.difficile) clinical trials, clinical studies, clinical research and observational studies evaluating interventions for C. difficile prevention, treatments, and environmental safety.

In the USA: Nearly half a million Americans suffer from Clostridium difficile (C. diff.) infections in a single year according to a study released in 2015 by the Centers for Disease Control and Prevention (CDC). Approximately 29,000 patients died within 30 days of the initial diagnosis of C. difficile. Of those, about 15,000 deaths were estimated to be directly attributable to C. difficile infections making C. difficile a very important cause of infectious disease death in the United States.

“Clostridium difficile infections are not only the most common cause of healthcare-acquired infections in the United States but also very common in the community in younger patients who previously were thought to be less susceptible to C. difficile. The rate of recurrent C. difficile infections is increasing tremendously and this increase is higher than the rate of primary C. difficile infections,” stated Sahil Khanna, MD, Assistant Professor of Medicine Division of Gastroenterology and Hepatology, Director of the C. difficile Clinic, Fecal Microbiota Transplantation program and C. difficile related Clinical Trials, Mayo Clinic, Rochester, MN.

Dr. Khanna also added, “It is imperative and important for clinical trials to be done to advance the development of new treatments, new medications, and new ways to prevent and treat Clostridium difficile infections.”

Individuals volunteer to participate in clinical trials in hopes of improving their own health, to access treatments that might not be available otherwise, often because they are new and not yet widely available. They help others by contributing to advances in medicine. There can also be potential risks participating in clinical trials and clinical studies. All of the known risks associated with a particular trial and or study will be discussed during the informed consent process. It will be thoroughly explained in the informed consent document that a volunteer will receive from the research staff prior to participating in any study.

To learn more about clinical research (e.g., Clostridium difficile, C.difficile) visit the U.S. Food and Drug Administration http://www.fda.gov or telephone 1-800-835-4709, The National Institutes of Health (NIH) http://www.nih.gov and ClinicalTrials.gov.

“Clinical trials are vital to improving our knowledge about how best to prevent and treat C. difficile infections. Informing patients of clinical trials is important, and in recent years several clinical trials have led to significant improvements in the treatments available for patients with C. difficile infections,” stated Mark Wilcox, MD, FRCPath, Consultant Microbiologist, Head of Microbiology and Academic Lead of Pathology Leeds Teaching Hospitals, Professor of Medical Microbiology University of Leeds Institute of Biomedical and Clinical Sciences, Lead on Clostridium difficile for Public Health England, UK.

About the U.S. Food and Drug Administration (FDA):
The FDA is responsible for protecting the public health by assuring that foods are safe, wholesome, sanitary and properly labeled; ensuring that human and veterinary drug, and vaccines and other biological products and medical devices intended for human use are safe and effective. FDA’s responsibilities extend to the 50 United States, the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and other U.S. territories and possessions.

About the National Institutes of Health (NIH):
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency making important discoveries that improve health and save lives.

About ClinicalTrials.gov
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.

Summit Announces Positive Data From Phase 2 C. difficile Clinical Trial Supporting Ridinilazole To Treat C. diffiicle Infection

SUMMIT ANNOUNCES POSITIVE TOP-LINE DATA FROM AN EXPLORATORY PHASE 2 CLINICAL TRIAL SUPPORTING RIDINILAZOLE AS A HIGHLY SELECTIVE ANTIBIOTIC FOR THE TREATMENT OF CDI

  • Ridinilazole treatment more preserving of gut microbiome than fidaxomicin

 * Listen In on September 26th 10aPT/1pET www.cdiffradio.com   live broadcast with our guests from Summit Therapeutics.

 

 

Oxford, UK, 5 September 2017Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), today announces positive top-line data from an exploratory Phase 2 clinical trial that support ridinilazole as a highly selective and potent antibiotic product candidate for the treatment of CDI. In the Phase 2 clinical trial, ridinilazole preserved the gut microbiome of CDI patients to a greater extent than the marketed narrow-spectrum antibiotic, fidaxomicin. During the trial’s ten-day treatment period, ridinilazole treatment had markedly less impact on the gut microbiome of trial patients by measures of overall diversity and changes in key bacterial families, when compared to those trial patients dosed with fidaxomicin.

 

In the trial, ridinilazole and fidaxomicin both reduced the abundance of C. difficile. However, fidaxomicin-treated patients had reduced abundancy of other bacterial families associated with microbiome health. For a number of these bacterial families, the difference between the two treatments was statistically significant. Another measure of microbiome health is alpha diversity as measured by the Simpson’s Diversity Index. There was a greater reduction in alpha-diversity during fidaxomicin treatment compared with ridinilazole-treated patients. These measures were a key secondary endpoint of the clinical trial and provide additional evidence of ridinilazole’s precision in killing C. difficile while preserving the gut microbiome. The primary endpoint of the trial was safety, as measured by the number of treatment emergent adverse events and serious adverse events. During the trial, no new or unexpected safety signals were identified and ridinilazole was well-tolerated.

 

“We increasingly recognise the importance of a healthy and diverse gut microbiome for protection against recurrent CDI, which is a major challenge in the management of the disease. These latest clinical findings show ridinilazole better preserved the microbiome of CDI patients than fidaxomicin, the narrowest spectrum antibiotic currently available for CDI,” commented Professor Mark Wilcox, Consultant Microbiologist & Head of Microbiology Research & Development at the Leeds Teaching Hospitals NHS Trust, Professor of Medical Microbiology at the University of Leeds, and Public Health England’s Lead on C. difficile in England. “Further, these microbiome data are very supportive of ridinilazole’s profile as a highly selective antibiotic with the potential to achieve a meaningful improvement in clinical outcomes for CDI patients.”

 

The exploratory open-label Phase 2 clinical trial enrolled 27 patients aged between 18 and 90 years at trial sites in the US, the UK and the Czech Republic. Patients were randomly assigned to receive either ridinilazole (200mg, twice a day) or fidaxomicin (200mg, twice a day) for ten days. The trial population was unbalanced with more patients randomised to ridinilazole at higher risk of poorer clinical outcomes as measured by ATLAS score, and also with predisposing factors for recurrent CDI.

 

A secondary endpoint of sustained clinical response (‘SCR’), defined as clinical cure at the end of treatment and no recurrence of CDI within the next 30 days, was achieved in seven of 14 ridinilazole treated patients and six of 13 fidaxomicin treated patients. The trial was not designed for efficacy comparisons due to the small number of patients.

 

Dr David Roblin, Chief Medical and Operating Officer of Summit added, “Ridinilazole is a precision antibiotic that is designed to selectively target C. difficile while being highly preserving of the gut microbiome that plays a crucial role in naturally protecting against recurrent CDI. Ridinilazole has now provided evidence of its high selectivity in two complementary clinical trials. The data from our earlier Phase 2 trial showed a greater microbiome preservation of ridinilazole-treated patients compared with the current standard of care, vancomycin, which led to achieving statistical superiority in sustained clinical response. We believe ridinilazole has the potential to become a front-line therapy for CDI and look forward to initiating Phase 3 clinical trials in the first half of 2018.”

 

More detailed findings from this trial are expected to be presented at an upcoming international infectious disease conference. The results build on positive data from a Phase 2 proof of concept trial of ridinilazole that were published in The Lancet Infectious Diseases in April 2017. Ridinilazole is currently being prepared for Phase 3 clinical trials that are planned to commence in the first half of 2018.

 

SOURCE:  www.summitplc.com

The Latest Developments in C. diff Research and Treatment

 

 

 

 

 

The Program Podcast is Now Available —

Listen at your leisure as our guest, Dr Mary Beth Dorr, PhD, Clinical Director, Clinical Research, Infectious Diseases, and he product development team lead for bezlotoxumab, Merck & Co., Inc.  provided us with an overview of a C. diff. infection, the challenges of recurrence, the latest clinical research overview, current treatment landscape, and pending new C. diff infection treatment guidelines from the Infectious Diseases Society of America (IDSA) that are anticipated to be released fall of 2017.

Click on the C. diff. Spores and More Logo to be connected to the podcast

MGB Biopharma Announced That the US FDA Has Granted Qualified Infectious Disease Product Designation For Treatment Of Clostridium difficile-associated Diarrhea (CDAD)

MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announced that the US Food and Drug Administration (FDA) has granted MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated Diarrhoea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of cases of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical phase I study of MGB-BP-3 confirmed the compound was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora. MGB is preparing to initiate the phase II clinical study for MGB-BP-3 and investigate the safety and efficacy in patients with CDAD, caused by the most virulent ribotype of C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.

Dr Miroslav Ravic, CEO of MGB Biopharma, said, “We are very pleased with the FDA’s decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhoea (CDAD). Granting of the QIDP designation highlights the potential of MGB-BP-3 to address serious and life-threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the phase II clinical trial.”

Dr Ravic, added, “Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit. Our MGB-based anti-infectives have the potential to deliver significant advantages over current approaches.”

While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.

 

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

http://www.pharmabiz.com/NewsDetails.aspx?aid=97421&sid=2

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.

Valneva’s C difficile Vaccine Candidate Reported Positive Phase II Results

Racing against big-name vaccines players, Valneva reported positive Phase II results this week for its GlaxoSmithKline-partnered C. difficile vaccine candidate, saying the shot proved to be “highly immunogenic” while also offering a good safety and a tolerable profile.

The trial, conducted in Germany and the United States, tested the vaccine candidate in 500 volunteers separated into two age groups: 50 to 64 and 65 and above. Researchers reported that the vaccine was immunogenic at all doses and formulations tested, with a high-dose formulation containing no adjuvant generating a superior response.

With the results, the Lyon, France-headquartered company said it’ll announce further development steps after its final Phase II closeout in Q2 2016.

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

http://www.fiercevaccines.com/story/valnevas-c-diff-vaccine-found-be-highly-immunogenic-phii/2015-12-01

 

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

Rebiotix Named Recipient Of the 2015 Tekne Award From MHTA

rebiotixlogo

The Minnesota High Tech Association (MHTA) has named Rebiotix as the recipient of the 2015 Tekne Award in the Small and Growing Healthcare award category.

Held November 18th at the Minneapolis Convention Center, the Tekne Awards honor companies and individuals who have played a significant role in developing new technologies that positively impact the lives and futures of people living around the world.

Rebiotix is pioneering Microbiota Restoration Therapy (MRT) for delivering live microbes into a sick patient’s intestinal tract to treat disease. The lead product, RBX2660 (microbiota suspension), is being studied for the treatment of the debilitating intestinal infection known as Clostridium difficile infection (C. diff.), an infection that is facilitated by antibiotic use. Antibiotic resistance is a major cause of concern in the U.S. healthcare setting. In the U.S. alone, there are approximately 29,000 deaths annually from the disease.i With 20-30% of patients with C. diff. experiencing more than one episode of the disease, new therapies beyond antibiotics are urgently needed.ii

“We are honored to receive this award and recognition for our work in a rapidly developing category of the microbiome,” said Rebiotix CEO Lee Jones. “We will continue on our path with this disruptive technology to help patients with debilitating gastrointestinal diseases return to a more healthy and normal function.”

Tekne Awards were presented to 15 of Minnesota’s most influential companies and recognized innovations in education technology, energy, healthcare, software, workforce development, manufacturing, agriculture, cyber security, and information technology.

“Technology is responsible for some of the most monumental changes in society today, and Minnesota continues to contribute to these advancements,” said Margaret Anderson Kelliher, president and CEO of MHTA. “We are pleased to recognize Rebiotix Inc. for its proven leadership and commitment to science and technology innovation in Minnesota.”

This year’s Tekne Awards ceremony was emceed by Amelia Santaniello.  A list of 2015 Tekne Award recipients and finalists is available online at http://www.tekneawards.org.

rebiotixlogo