Tag Archives: CDI treatment

Breaking News in Treatment of Recurrent C. difficile Infection : Rebiotix, Inc. Receives Breakthrough Therapy Designation for Microbiota Restoration Therapy RBX2660 by U.S. Food and Drug Administration

Rebiotix Receives Breakthrough Therapy Designation for RBX2660A Microbiota Restoration Therapy (MRT) for the Treatment of Recurrent Clostridium difficile Infection

Milestone reinforces Rebiotix as a leader in microbiota-based drug development and product commercialization

Rebiotix Inc. announced that U.S. Food and Drug Administration (FDA) has designated its lead Microbiota Restoration Therapy (MRT) RBX2660 as a Breakthrough Therapy for the treatment of recurrent Clostridium difficile (C diff) infection, a challenging to treat gastrointestinal (GI) infection that causes 29,000 deaths in the U.S. annually.

Rebiotix is a clinical stage biotechnology company that was founded to revolutionize the treatment of debilitating GI diseases by harnessing the power of the human microbiome. MRT is the Rebiotix drug platform for delivering healthy, live, human-derived microbes into a sick patient’s intestinal tract to treat disease.

Studies have shown that most cases of C diff infection occur after the normal microorganisms that reside in the gut have been disrupted by antibiotic use. Restoring the balance of microbes is thought to be key to breaking the cycle of recurrence. Lead Rebiotix product, RBX2660, is targeted at treating recurrent C diff.

“The development of RBX2660 represents our commitment to harnessing the microbiome to develop therapies for debilitating and sometimes fatal disease for which there is currently no FDA-approved alternative,” said Rebiotix CEO Lee Jones. “The Breakthrough Therapy Designation marks the third regulatory milestone for our lead product, RBX2660, in the past two years, and reinforces our leading efforts that have brought us to the cusp of delivering a revolutionary and validated treatment to patients living with recurrent C diff.”

About the Breakthrough Therapy Designation

According to the FDA, Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). For more information please visit http://www.fda.gov/forpatients/approvals/fast/ucm405397.htm.


For additional Information click on the following link:


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


Seres Therapeutics Focused On Developing Drugs To Treat Diseases Of The Microbiome With First Clinical Program ECOSPOR Research Study In The Treatment Of C. diff. Infection (CDI) And Now Open For Enrollment

Seres Therapeutics is a clinical-stage therapeutics company focused on discovering and developing drugs to treat diseases of the microbiome. The biology of the microbiome is driven by ecologies—the functional collections of various organisms—which are central to health and disease.

Seres is developing Ecobiotic® therapeutics to treat diseases that have an underlying microbiome biology. Seres Therapeutic’s first clinical program, The ECOSPOR Research study is in the treatment of Clostridium difficile  infection (CDI).
About The ECOSPOR Research Study

Although antibiotics are used to treat recurrent C. difficile infection, most of the time they do not cure C. difficile. In addition, antibiotics continue to wipe out the good bacteria that protect you against C. difficile. Currently, there are no medications available that can prevent this infection from coming back when your gut is defenseless.

SER-109 is an investigational medicine being developed to prevent recurrent C. difficile from coming back again. The idea is to first treat patients with antibiotics that work against C. difficile so that the diarrhea goes away. Then patients may get SER-109 to keep the C. difficile infection from coming back.

In the ECOSPOR study, doctors will compare SER-109 to a placebo pill, which looks like SER-109. However, the placebo pill will have no medication inside it. Patients will be randomly assigned to receive either SER-109 or placebo. The study is designed to provide more information about the potential safety and effectiveness of SER-109, and will last about 7 months. The results will help doctors and researchers learn whether SER-109 could one day be used to prevent recurrent CDI.

The ECOSPOR Study is now open for enrollment. If you would like more information the study is posted on ClinicalTrials.gov.

You can all contact clinicalstudies@sereshealth.com or by calling  1-617-945-9626  (USA) to find a doctor near you who is involved in the study.



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

Service Evaluation Study Data Shows DIFICLIR [TM] fidaxomicin by Astellas Pharma EMEA Reduces Recurrence and All-Cause Mortality When Used First-Line in All Patients Diagnosed With Clostridium Difficile (CDI) Infection

Presented May 20th, 2015 at the 5th International Clostridium Difficile Symposium (ICDS) in Bled, Slovenia, the CDI Service Evaluation Study is the first and only real-world multicenter study assessing the effectiveness of current CDI treatment in NHS Secondary Care Trusts in England.[6]

“This study builds on the growing evidence that adopting fidaxomicin as first-line treatment for all patients with CDI, rather than reserving it for more severe cases, provides the best outcomes in terms of recurrence, all-cause mortality and cost effectiveness compared to older treatments – vancomycin and metronidazole”, comments Dr Simon Goldenberg, Consultant Microbiologist and Infection Control Doctor, Guy’s and St Thomas’ NHS Foundation Trust. “A previous study also showed that first-line use of fidaxomicin reduces environmental contamination compared to those treated with vancomycin or metronidazole, further demonstrating the role fidaxomicin may play in reducing the spread and incidence of CDI alongside stringent hospital hygiene protocols.”

 In Europe the incidence and severity of CDI is increasing,[1],[2],[3],[4] with nearly 125,000 cases a year,[5] posing a major threat to healthcare systems and patientsData presented today from the CDI Service Evaluation study shows that the adoption pattern of treatment impacts CDI outcomes. Compared to traditional broad-spectrum antibiotics, first-line use of fidaxomicin – a targeted treatment – in all CDI patients provides the best outcomes in terms of recurrence rate, all-cause mortality and cost effectiveness, compared to use in selected patients only.[6] CDI is associated with high-mortality[7] and cost burden,[8] therefore reducing the incidence and recurrence of CDI is a priority for clinicians, payers and health authorities alike.
Over 1,450 patients were included in the analysis conducted in seven UK hospitals that introduced fidaxomicin, a narrow-spectrum antibiotic for the treatment of CDI, between July 2012 and July 2013.[6] Data collected from 177 patients treated first-line with fidaxomicin during the 12-month evaluation period were compared with those from a retrospective cohort treated with broad-spectrum antibiotics – vancomycin and metronidazole – during the previous 12-month period.[6]

In the two centres (A and B) where fidaxomicin was adopted as a first-line treatment for all patients diagnosed with CDI, a significant reduction in 28-day all-cause mortality was observed, from 18.2% to 3.1% (P<0.001) and 17.3% to 6.3% (P<0.05) respectively.[6],[9] The real-world analysis also supports clinical trial data in highlighting dramatically reduced recurrence rates: from 12.1% and 23.5% with vancomycin and metronidazole, to 3.1% in both centres with first-line fidaxomicin. For every 50 patients treated, this would result in 5 and 10 recurrences avoided in the two centres respectively.[6]

A separate study recently looked at the impact of CDI treatment on environmental contamination. The analyses showed those treated with fidaxomicin are more than 20% less likely to contaminate their environment with CDI (36.8%) compared to patients treated with metronidazole and/or vancomycin (57.6%). This significant decrease in environmental contamination may further contribute to a reduction in secondary cases of CDI.[10]

“The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) identified recurrence as the next big challenge to be met in the treatment of CDI, since it occurs in up to 25% of patients treated with current broad-spectrum therapies,” comments Professor Mark Wilcox, Professor of Medical Microbiology, Leeds Teaching Hospitals & University of Leeds. “Fidaxomicin has limited activity against the ‘good bacteria’ in the gut and so can be considered to be a targeted treatment option. Preservation of the gut microflora likely contributes to the lower rates of recurrence seen after fidaxomicin treatment of CDI compared with those associated with broader-spectrum antibiotics like vancomycin.”

A CDI recurrence has been previously estimated to add an additional £20,249 on top of an estimated £13,146 spent to treat the initial infection due to prolonged hospital stay, ICU stay, high cost drugs and the surgery necessary to tackle it.[11] An in-depth costing analysis at the two centres that adopted fidaxomicin as a first-line treatment revealed that in centre A the 5 recurrences that could be avoided for every 50 patients treated with the narrow-spectrum antibiotic would result in a cost saving of £19,490, and in centre B, for the 10 recurrences avoided, a cost saving of £121,144.[6] With nearly 125,000 cases of CDI occurring in Europe each year,[5] the potential cost saving for the treatment of this potentially fatal condition is likely to be far greater.

The cost-effectiveness of fidaxomicin has been reinforced in a recent study in France, with fidaxomicin proving to be both clinically and cost-effective compared to vancomycin.[12] The main driver of cost-effectiveness was a significant reduction in the rate of recurrence, resulting in a reduced cost of hospitalisation.[12] In the base case, fidaxomicin was cost-effective compared to vancomycin for all patients at a cost per QALY of €24,242.[12] The cost per recurrence avoided was €1,877 and cost per faecal transplant avoided was €8,967.[12]

In Europe the incidence and severity of CDI is increasing, posing a major threat to healthcare systems and patients.[1],[2],[3],[4] Information suggests that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients.[7] This suggests that CDI contributes to the death of around 27,000 people each year across Europe,[7] around five times that of MRSA associated deaths.[13]

ESCMID guidelines currently recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI.[14]


About the CDI Service Evaluation study[6]

The CDI Service Evaluation Project is the first and only real-world multicenter study assessing the effectiveness of current CDI treatment for UK patients in NHS Secondary Care Trusts in England. This evaluation looked specifically at the cost-effectiveness of fidaxomicin in clinical practice versus standard of care treatments (vancomycin and metronidazole) in seven trial centres from across the UK:

•    Leeds Teaching Hospitals NHS Trust

•    Guy’s and St Thomas’ NHS Foundation Trust

•    County Durham & Darlington NHS Foundation Trust

•    University Hospitals of Morecambe Bay – NHS Foundation Trust

•    St George’s Healthcare NHS Trust

•    University Hospitals of Leicester NHS Trust

•    Derby Hospitals NHS Foundation Trust


The study was sponsored by Astellas Pharma Ltd.

About Clostridium difficile Infection

CDI is a recurring and preventable illness resulting from infection of the internal lining of the colon by C. difficile bacteria.[15] The bacteria produce toxins that cause inflammation of the colon, diarrhoea and, in some cases, death.[16] Patients typically develop CDI after the use of broad-spectrum antibiotics that disrupt normal bowel flora, allowing C. difficile bacteria to flourish.[17] CDI is highly infectious[18] and has surpassed MRSA as a leading cause of healthcare-acquired infection.[19] It is most common in those taking broad-spectrum antibiotics that result in the disruption of normal bowel flora,[20] and threatens those most vulnerable, including the elderly, patients who are immunocompromised or with renal impairment and those who have prolonged periods of hospitalisation.[21],[22] People in hospital with CDI are up to three times more likely to die in hospital (or within a month of infection) than those without CDI.[23],[24] Information suggests nearly 125,000 cases of CDI occur in Europe each year,[5] and that CDI results in death for 9% (2% primary cause, 7% contributory) of all diagnosed patients.[7] Recurrence of CDI occurs in up to 25% of patients within 30 days of initial treatment with current therapies.[25],[26],[27] The ESCMID has identified recurrence as being the most important problem in the treatment of CDI.[28]

About DIFICLIR (fidaxomicin)

DIFICLIR (fidaxomicin) is a first-in-class macrocyclic antibiotic targeted to kill the C. difficile bacteria[29] while sparing the ‘good’ gut bacteria,[30],[31],[32] and represents the newest development in CDI for over 20 years.[33],[34] In the largest Phase III trials in this area fidaxomicin was shown to be non-inferior in initial cure and clearly superior to current standard of care treatment – vancomycin – in achieving sustained clinical cure and addressing recurrence.[27],[35] ESCMID guidelines recommend DIFICLIR as a first line therapy option in CDI patients at risk of recurrence and in patients with severe and non-severe CDI.[14] The safety profile of DIFICLIR is based on data from 564 patients with CDI treated with fidaxomicin in Phase III studies.[33]

About Astellas Pharma EMEA

Astellas Pharma EMEA operates in 40 countries across Europe, the Middle East and Africa, and is the EMEA regional business of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation’s focus is to deliver outstanding R&D and marketing to continue growing in the world pharmaceutical market. Astellas presence in Europe also includes an R&D site and three manufacturing plants. The company employs over 4,500 people across the EMEA region. In 2013 Astellas was awarded SCRIP Pharmaceutical Company of the Year in recognition of its commercial success and pipeline development.