The first thing Clinical Trials In Progress ♥(Could not hyperlink (from the C diff Foundation's web site.)
Every scientific research and development, every clinical trial in progress is a glimmer of hope………..HOPE for clinically safe and approved avenues to prevent and treat a
C. difficile infection.
Listed below you will find information pertaining to organizations who have active
C. difficile Prevention and Treatment clinical trials in progress. Click on each organization’s website listed to review their clinical trial study opportunities — Inquire if you or your loved one qualify to participate in their study.
To Learn More About Clinical Trials —
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Learn more About Clinical Studies and About This Site, including relevant History, Policies, and Laws. Click on the link below to be redirected to the clinicaltrials.gov website:
Clinical Studies In Progress To
Help You — Help Them — Help Others ♥
“The C Diff Foundation’s mission is to educate and advocate for Clostridium difficile infection prevention, treatments, support, and environmental safety worldwide.
The C Diff Foundation’s organization is comprised of 100% volunteering members who are dedicated to our mission and adhere to the Foundation’s Code of Ethics
which prohibits the endorsement and paid promotion of products, services, medications, or clinical studies in progress.
All website entries, public presentations, and workshops are to raise C. diff. infection awareness in all areas of the C Diff Foundation’s mission statement, including infection prevention, sepsis, healthcare-associated infections, antimicrobial resistance, antibiotic stewardship and provide education on all the above.”
Here is a list of Clinical Trial Phases:
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.
Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Additional Resource Information on clinical trials can be found at http://clinicaltrials.gov/info/resources
C. diff. Infection (CDI)_Prevention Clincal Studies In Progress
UPDATE: On May 11, 2017 The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation for SYN-004 (ribaxamase) for the prevention of Clostridium difficile infection.
Synthetic Biologics’ SYN-004 Phase 2b Proof-of-Concept Clinical Trial
Synthetic Biologics is developing cutting-edge therapeutics to treat pathogen-specific diseases.
Our two leading candidates are:
SYN-004 (ribaxamase) to prevent C. difficile infection and antibiotic-associated diarrhea
SYN-010 to treat irritable bowel syndrome with constipation (IBS-C)
A global, multi-center, randomized, double-blind, placebo-controlled clinical trial to evaluate the ability of SYN-004 to degrade certain IV beta-lactam antibiotics within the GI tract to maintain the natural balance of the gut microbiome for the prevention of C. difficile infection, C. difficile associated diarrhea and antibiotic-associated diarrhea in patients hospitalized for a lower respiratory tract infection and receiving IV ceftriaxone.
Update July 2016:
the United States Adopted Names Council (USAN) of the American Medical Association has approved the use of “ribaxamase” (Rye-bak’-sa-mase) for Synthetic Biologics’ SYN-004. Ribaxamase is the Company’s Phase 2 development candidate designed to protect the gut microbiome from the unintended effects of certain commonly used intravenous (IV) beta-lactam antibiotics for the prevention of C. difficile infection (CDI), antibiotic-associated diarrhea (AAD) and the emergence of antibiotic-resistant organisms.
Synthetic Biologics recently reported positive results from two Phase 2a clinical trials demonstrating a correlation of the 150 mg dose of ribaxamase with the degradation of residual IV ceftriaxone alone, and in the presence of the proton pump inhibitor (PPI), esomeprazole, to levels that were near or below detectable in the intestinal chyme of healthy participants with functioning ileostomies. A Phase 2b proof-of-concept, randomized, placebo-controlled clinical trial is currently underway to evaluate the ability of ribaxamase to prevent CDI and AAD in patients hospitalized with a lower respiratory tract infection and receiving IV ceftriaxone. An interim analysis of blinded data performed by an independent data monitoring committee is expected in summer of 2016.
“The approval of the generic name ribaxamase for SYN-004 by USAN is a defining milestone for Synthetic Biologics. Ribaxamase represents a newly created and innovative first-in-class drug designed to protect the naturally occurring gut microbiome from the unintended consequences of antibiotic use,” said Jeffrey Riley, President and Chief Executive Officer. “By degrading certain IV beta-lactam antibiotics before they reach the gastrointestinal (GI) tract, ribaxamase may not only prevent the onset of CDI and AAD, but has the potential to be an instrumental tool for preventing the emergence of antibiotic resistance in organisms which comprise the gut microbiome. We are excited for the continued clinical development of ribaxamase and look forward to sharing our progress including announcing results from our ongoing global Phase 2b proof-of-concept clinical trial.”
Click here to see if there’s a study site in the U.S. near you and if you’re eligible.
Click here to learn more about SYN-004.
Da Volterra is a biopharmaceutical company, privately-held and headquartered in Paris (France), focused on the discovery and development of innovative therapeutic and preventive products for Clostridium difficile and multi-resistant infections. Our most advanced product, DAV132, is designed as a prophylactic treatment intended to prevent the development of
C. difficile infection, by binding with and neutralizing common antibiotics in the gut.
DAV132 decreases the risk of triggering CDI by inactivating residual antibiotics in the colon
before they can disrupt the bacterial flora, without impacting the systemic efficacy of the antibiotics.
It is noteworthy that DAV132 is developed to accompany all oral and intravenous antibiotics of any class and would therefore significantly reduce the risks to acquire C.difficile infections for patients at risk (especially patients who had prior episodes). We see DAV132 as a real game changer for C.difficile prevention.
Have a look at our video presenting the mechanism of action of DAV132:
http://davolterra.com/content/dav132-pr ... ions-video
The video is highly illustrative of what C.diff is and how C.diff is triggered.
We have already performed 2 clinical trials with DAV132 and we have a very exciting dataset (both preclinical and clinical) suggesting that DAV132 will very effectively prevent C.diff infections. I would be happy to exchange with you more information on this. Our next clinical trial, in patients actually treated with antibiotics and at-risk of C.diff, will start in Q4 2015 or early 2016
Pfizer Announces Positive Top-Line Results from Phase 2 Study of
Investigational Clostridium difficile Vaccine for the
Pfizer’s C. difficile Vaccine Candidate to Commence Phase 3 Study in First Half of 2017
On Thursday, January 26, 2017 Pfizer Inc. announced that the Phase 2 study evaluating the Company’s Clostridium difficile (C. difficile) vaccine candidate, PF-06425090, provided positive data, based on a pre-planned interim analysis. The randomized Phase 2 study (NCT02561195) examined the safety, tolerability, and immunogenicity of the vaccine in healthy adults 65 to 85 years of age. Pfizer’s vaccine candidate is designed to help prevent
C. difficile infection (CDI), which can include life-threatening diarrhea and pseudomembranous colitis,1 by inducing a functional antibody response capable of neutralizing the two main disease-causing toxins produced by C. difficile (toxins A and B).2
“Despite improved infection control measures, C. difficiledisease continues to rise, further augmenting an already urgent public health threat with particular negative impact on older adults,” said Kathrin Jansen, Ph.D., senior vice president and head of Vaccine Research and Development for Pfizer Inc. “We are very encouraged by these interim immunogenicity and safety results demonstrating robust increases in vaccine-elicited neutralizing antibodies to both toxins, that we believe could provide protection against C. difficile disease.”
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at http://www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is as of January 26, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about a vaccine candidate, PF-06425090, including its potential benefits and the expected timing of commencement of a Phase 3 study, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with interim data; whether and when any biologics license applications may be filed for PF-06425090; whether and when any such applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of PF-06425090 and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov (link is external) and http://www.pfizer.com.
1 Cohen SH et al. Infect Control Hosp Epidemiol. 2010;31:431-455.
2 Gerding DN and Young VB. Clostridium difficile infection. In: Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, 8th ed. Bennett JE, Dolin R, Blaser MJ (eds). Philadelphia, PA: Elsevier Saunders; 2015.
3 U.S. Food and Drug Administration. Fast Track. http://www.fda.gov/ForPatients/Approval ... 405399.htm (link is external). Accessed January 2017.
A C.diff. Study
Research Study Summary
A Phase 3, Placebo-controlled, Randomized, Observer-blinded Study To Evaluate The Efficacy, Safety, And Tolerability Of A Clostridium Difficile Vaccine In Adults 50 Years Of Age And Older
The Clover trial is evaluating an investigational vaccine that may help to prevent Clostridium difficile infection. Participants in the study are adults 50 years of age and older, who are at risk of developing Clostridium difficileinfection. The study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated.
Each subject will receive 3 doses of Clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential Clostridium difficile infection.
To Learn more
Review research study eligibility criteria »
Contact information for clinical study »
CW ID: 224554
Date Last Changed: May 17, 2017
Phase3, GenderBoth Male and Female, Age50 and up, Overall Status Recruiting, Lead Sponsor: Pfizer, Duration: 18 Months, Facility Type: Out-Patient
LEARN MORE ABOUT THE CLOVER TRIAL Click on the link below
— The following site is intended for use by United States residents only. If you are located outside of the United States, please refer to http://www.clinicaltrials.gov.
Seres Therapeutics is developing Ecobiotic® drugs designed to prevent C diff infections from coming back again.
Most C diff infections occur after antibiotic treatment. Why? Our gut contains trillions of microbes, called the microbiome, which protects us from bacterial invaders that can cause disease. Antibiotics kill both good and bad bacteria, leaving holes in this ecology (community) of microbes. When the microbiome is damaged, bad bacteria, like C diff, can take advantage and cause disease. Although specific antibiotics can kill the active C diff bacteria, the sleeping forms (ie, spores) are untouched. These spores turn into active C diff bacteria and cause disease again and again – usually afSlow down and enjoy the journey. This past year has reminded me that when it is our time to leave this body no one can stop it. We have one life to live. The material things we invest in are left behind only to be discarded. I'm going to start a "reunion of friends and family". The idea is to see who reads a post without a picture. If no one reads my post, this will be a very short experiment. But if you are reading this message, make a comment using a single word about how we met. After that, copy this message on your wall and I will also leave you a word. Please, don't leave a word and then not bother to copy the text. You'll ruin all the fun and reminiscing.ter antibiotic treatment has finished.
Seres Therapeutics has developed an oral medicine called SER-109, which aims to prevent C diff from coming back by repairing the microbiome. This Ecobiotic® drug is being studied in a large Phase 3 clinical trial that is enrolling patients who have had multiple C diff infections. This important clinical study is being done in the United States and Canada and may provide the final clinical data needed to support FDA and Canadian drug approvals. For more information, please follow this link to the patient website: https://serescdiffstudy.com/
Seres Therapeutics is also enrolling patients into a phase 1b trial of SER-262, which is an Ecobiotic® drug to prevent recurrence among those experiencing their first C diff infection.
For more information visit the website: http://www.serestherapeutics.com and click on the tab “Clinical Trials” tab located at the top of the page and scroll down to SER-262 to learn more about this study.
To learn more about Seres Therapeutics please click on the following link to be redirected:
Valneva Announces Start of Phase II Clinical Trial of its Clostridium difficile vaccine candidate
UPDATE: Valneva SE July 26, 2016 announced the successful completion of its Phase II study for its prophylactic vaccine candidate VLA84 targeting primary prevention of C. difficile infection (CDI), which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide. Valneva previously announced positive top-line data from the Phase II study at the end of 2015. These initial results, which included data up to Day 56 following initial vaccination, were presented at the American Society of Microbiology’s annual meeting, ASM Microbe 2016, on June 17 in Boston. VLA84 was immunogenic at all doses and formulations tested, in that Immunoglobulin G (IgG) and functional (neutralizing) antibody responses were observed. The study met its primary endpoint in terms of identifying the dose/formulation with the highest seroconversion rate against both toxins A and B and confirmed the favorable safety profile observed in Phase I.
Final Phase II results included the follow-up of study participants until Day 210. This long-term data confirmed the optimal vaccine dose and formulation that had been previously identified (high-dose formulation without adjuvant) with an immunogenicity profile at Day 210 in line with expectations. Long-term safety concerns were not seen in any of the different vaccine doses tested.
First Study participant(s) enrolled in Phase II trial which aims to enable Phase III entry upon successful completion
Study to enroll 500 healthy subjects aged 50 years and older in the United States and Germany
First results are expected in Q4 2015
Lyon (France), December 18, 2014 – European biotechnology company Valneva SE (“Valneva”) announced today the initiation of the Phase II clinical trial of its VLA84 prophylactic vaccine candidate against Clostridium difficile (C. difficile), the main cause of nosocomial diarrhea. Data from the Phase I study in healthy elderly and adults showed good safety and immunogenicity of the vaccine candidate, and indicated functionality of induced antibodies, supporting the Company`s decision to progress the vaccine
candidate into Phase II
C. diff. Infection (CDI) Treatments Clinical Studies In Progress
Summit Therapeutics has reported ‘outstanding’ results in the phase II trial of ridinilazole, its new C.difficile infection (CDI) treatment.
To LISTEN to the July 2016 Live Broadcast from the C. diff. Spores and More Global Broadcasting Network program with Dr. Richard Vickers, and Dr. Dr Kevin W Garey, PharmD, Click on the Summit Therapeutics Logo above : Ridinilazole, A Microbiome Preserving Antibiotic For The Treatment Of a C. difficile Infection
Reported January 2017: With input from the FDA and EMA, Summit intends to design the Phase 3 clinical programme to evaluate superiority of ridinilazole over standard of care in the treatment of C. diffiicle Infection (CDI).
A positive Phase 3 result on superiority has the potential to support the commercial launch of ridinilazole as a differentiated therapy that can both treat initial CDI and reduce disease recurrence.
Mr Glyn Edwards, Chief Executive Officer of Summit commented: “The constructive end of Phase 2 meetings with the US and European regulators have enabled us to design a Phase 3 programme that focuses on evaluating ridinilazole’s superiority over standard of care.
This is something we believe would help differentiate our novel class antibiotic from currently marketed CDI treatments and those in late-stage development. Superiority in the combined measure of treatment of initial infection and importantly, reduction in recurrence, could position ridinilazole for front-line treatment of CDI.”
Summit discussed its Phase 3 development programme with the FDA at an End of Phase 2 meeting and through a scientific advice process with EMA. With input from both agencies, the Phase 3 programme is expected to include two trials evaluating ridinilazole as compared to the standard of care, vancomycin, each of which would enrol approximately 700 patients with CDI with the primary endpoint being superiority in sustained clinical response (‘SCR’). Other planned endpoints will include health economic outcome measures. The Phase 3 trial designs are consistent with the successful proof of concept Phase 2 trial, CoDIFy, in which ridinilazole achieved statistical superiority over vancomycin in SCR. SCR is a combined endpoint that measures cure at the end of treatment and a lack of recurrence in the 30 days after treatment. FDA also confirmed that ridinilazole would be eligible for Priority Review based on its QIDP designation.
During the trial, the new oral antibiotic significantly outperformed vancomycin, the current standard prescription, which was the primary objective said Summit.
Over two-thirds (66.7%) of those treated showed a sustained clinical response (SCR) against 42.4% for vancomycin.
The statistical superiority was driven by a large numerical reduction in recurrent disease compared with vancomycin, which Summit said was key as recurrence is one of the hardest things to stop.
C.difficile or CDI is a growing danger for patients in hospital, care homes and the wider community.
Annually, there are between 450,000 and 700,000 cases in the US alone, with the elderly and sick especially vulnerable.
One study has suggested it costs US $4.8bn to treat these people.
“The healthcare community is acutely aware of the major threat CDI poses, particularly given widespread antibiotic use and our aging population,” said Glyn Edwards, Summit’s chief executive.
The biggest unmet need in CDI treatment is reduce recurring cases, he added and the results from the latest trial had exceeded its ‘wildest expectations’.
“These outstanding clinical data from CoDIFy strongly support the profile of ridinilazole as a narrow spectrum antibiotic.
“There is a vital need for potent new antibiotics, and the potential of ridinilazole has attracted great interest.
Edwards added that the results from the CoDIFy trial were exceptionally encouraging and the aim no is to advance ridinilazole into Phase 3 clinical trials.
Here, the company would evaluate partnership opportunities against the benefit of it forward itself, he added.
Professor Mark Wilcox, at Leeds University and Public Health England’s lead consultant on C.difficile added that the latest data indicated ridinilazole could become an important new treatment option for CDI with the potential to reduce the high rates of recurrent disease that remain a key clinical challenge.
CoDIFy was a double blind, randomised, active controlled, multicentre, Phase II clinical trial that evaluated the efficacy of ridinilazole against vancomycin in 100 patients in the US and Canada.
Results from a second CoFIFy trail are due next year, though Edwards said the results announced today would provide the bulk of the quantitative data.
ridinilazole has already received Qualified Infectious Disease Product, or QIDP, designation and has been granted Fast Track status from the US Food and Drug Administration
Rebiotix Inc. is a clinical stage biotechnology company founded to revolutionize the treatment of debilitating diseases by harnessing the power of the human microbiome. Microbiota Restoration Therapy (MRT) is the company’s platform for delivering live microbes into a sick patient’s intestinal tract to treat disease.
August 2017 Update: Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, announced today that it has enrolled the first patient in a Phase 3 clinical trial of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection. RBX2660 is Rebiotix’s most clinically advanced drug product developed from the company’s Microbiota Restoration Therapy™ (MRT) platform. MRT is a standardized, stabilized drug technology that is designed to deliver a broad consortium of spore and non-spore forming microbes into a patient’s intestinal tract to restore a dysbiotic gut to a healthier state.The randomized, double-blind, placebo-controlled Phase 3 clinical trial will evaluate the efficacy and safety of RBX2660 for the prevention of recurrent Clostridium difficile (C. diff) infection. The primary endpoint of the trial compares the proportion of subjects with treatment success following a blinded treatment with RBX2660 compared to the blinded placebo arm. Treatment success is defined as preventing recurrent C. diff infection for eight weeks.
The multicenter Phase 3 clinical trial of RBX2660 will be conducted in the United States and Canada and is designed to support a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA).“Patients with debilitating, recurrent C. diff need solutions. We plan to continue our strong momentum generated by our Phase 2 results in this Phase 3 trial as we seek to advance RBX2660 toward registration and potential approval so patients have an option for this unmet medical need,” said Ms. Lee Jones, President and CEO of Rebiotix. “Initiating the Phase 3 clinical study of RBX2660 is a significant milestone for Rebiotix and showcases the potential of our Microbiota Restoration Therapy™ (MRT) platform to enable the development of microbiome-directed drug products.” “It’s exciting to see RBX2660 begin a Phase 3 trial for recurrent C. diff infection,” said Dale Gerding, MD, MACP, FIDSA, Professor of Medicine at Loyola University Chicago and Chief Medical Officer of Rebiotix. “This disease is especially challenging to treat and having this microbial therapy available to physicians could dramatically change how we manage the vexing problem of recurrences of this leading healthcare-associated infection.”
RBX2660 is the first drug product in clinical study from the Microbiota Restoration Therapy (MRT) platform The initiation of the Phase 3 clinical trial follows a Phase 2 program that evaluated the safety and efficacy of RBX2660 for the prevention of recurrent C. diff infection. The Phase 2 program consisted of three separate Phase 2 studies, including a randomized, double-blind, placebo controlled Phase 2b trial. The drug has been tested in approximately 300 patients with many followed to 24 months post treatment. Rebiotix is also advancing RBX7455, a lyophilized, room-temperature stable, oral capsule formulation of its MRT technology in an investigator sponsored Phase 1 study
April 2017 UPDATE: Rebiotix Inc., a clinical-stage microbiome company focused on harnessing the power of the human microbiome to treat challenging diseases, today announced topline results from a controlled open-label Phase 2 trial of RBX2660 (PUNCH™ Open Label) for the prevention of recurrent Clostridium difficile (C. diff.)infection.
RBX2660 has been granted Orphan Drug status, Fast Track status and gained Breakthrough Therapy Designation from the FDA in October 2015 for its potential to prevent recurrent C. diff. infection.
Data indicated that RBX2660 was well-tolerated and achieved the primary efficacy endpoint of preventing C. diff. recurrence; patients treated with RBX2660 exhibited a treatment success rate of 78.8% compared with a historical control of 51.8% (p<0.0001). RBX2660 is a broad-spectrum microbiota suspension that is designed to rehabilitate the human microbiome by delivering live microbes into a patient’s intestinal tract to treat disease.
Lee Jones, president and CEO of Rebiotix, stated, “The 78.8% treatment success achieved in this open label Phase 2 trial demonstrates the potential of RBX2660, a broad spectrum microbiota drug product, to rehabilitate the gut microbiome and break the cycle of C. diff.recurrence. These results, coupled with the safety and efficacy data observed in our prior Phase 2b and Phase 2 clinical trials, position Rebiotix to advance RBX2660 into Phase 3 clinical development, solidifying our standing as the most clinically advanced microbiome company in the industry.”
The first patient has been treated in a Phase 1 study of RBX7455 for the prevention of recurrent Clostridium difficile (C. diff.) infection. RBX7455 is a lyophilized non-frozen oral capsule formulation of Rebiotix’s Microbiota Restoration Therapy (MRT), a standardized, stabilized drug technology that is designed to rehabilitate the human microbiome by delivering a broad spectrum of live microbes into a patient’s intestinal tract via a ready-to-use and easy-to-administer format. RBX7455 lyophilized capsules remove the need for patients to keep the product frozen or refrigerated.
This prospective, single center, two-arm Phase 1 study is a proof of concept dosing study of RBX7455 for the prevention of recurrent C. diff. infection, an increasingly difficult-to-resolve intestinal infection that causes approximately 29,000 deaths in the U.S. each year.1 It is also the first clinical study of an oral microbiota therapy that allows the patient to take the medication at home. RBX7455 requires no special handling or storage needs for patients. The study will enroll approximately 20 patients at a single U.S. site and is being conducted by the Mayo Clinic, a nonprofit worldwide leader in medical care, research and education.
“New therapies are urgently needed to prevent recurrent C. diff., a debilitating, costly and potentially life-threatening infection,” said Dr. Sahil Khanna, Assistant Professor of Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic, who is leading the study. “RBX7455 not only provides standardized and stabilized human microbes orally, but may provide several advantages in terms of patient dosing and therapy accessibility since no freezing or refrigeration is needed when the patient takes the product home.”
The initiation of the Phase 1 study of RBX7455 enhances Rebiotix’s clinical pipeline of human microbiome-directed drug candidates. The Company’s lead drug candidate, RBX2660, recently completed a Phase 2b randomized, double-blind placebo-controlled trial examining the efficacy and safety of the microbiota restoration therapeutic as a prevention for recurrent C. diff. infection after a standard of care course of antibiotics (PUNCH™ CD2).
“Dosing the first patient in the Phase 1 study of RBX7455 is a significant milestone for Rebiotix as it solidifies our position as the most clinically advanced microbiome company in the industry, while showcasing the potential of our MRT platform to create new solutions for challenging diseases through standardized microbiota-based drug development,” stated Lee Jones, president and CEO of Rebiotix. “RBX7455 is a potentially ground-breaking product for Rebiotix and the entire microbiome industry in that the lyophilized oral capsules do not need to be kept frozen and thus can be stocked in a pharmacy with no special handling or storage needs. As such, RBX7455 offers the unique opportunity to introduce live microbial therapy as a potential treatment for numerous diseases where chronic or repeat dosing is required.”
About Mayo Clinic
Mayo Clinic is a nonprofit organization committed to medical research and education, and providing expert, whole-person care to everyone who needs healing. For more information, visit http://www.mayoclinic.org/about-mayo-clinic or newsnetwork.mayoclinic.org
Additional Clinical Program
PUNCH™ CD is the name of Rebiotix’s clinical program to assess the safety and efficacy of RBX2660 for the treatment of recurrent Clostridium difficile (C. diff.)infection. It is the most advanced human clinical program evaluating a microbiota-based drug conducted in coordination with the U.S. Food and Drug Administration (FDA) with the goal of developing and commercializing a new therapy to treat patients with recurrent episodes of C. diff. infection. Rebiotix has completed enrollment its PUNCH CD 2 study and continues to assess the safety and efficacy of RBX2660.
PUNCH™ CD 2
Rebiotix has completed enrollment in its PUNCH CD 2 study, a Phase 2B multi-center, randomized, double-blind, placebo-controlled trial to evaluate RBX2660 for the treatment of recurrent C. diff. infection. A total of 117 patients recruited at more than 20 sites in the U.S. and Canada were enrolled in the study, which is the largest randomized controlled study of a MRT for recurrent C. diff. to date.
In this study, the patients received either the microbiota-based drug or a placebo via enema. Neither the doctor nor the patients knew what treatment was received in order to get an unbiased measurement of the drug’s true effectiveness. If a patient’s C. diff. infection symptoms returned, even if they were in the placebo arm of the study, they may have been eligible to receive RBX2660. This is referred to as the open-label portion of the study.
The PUNCH CD study, which was a Phase 2 open label safety and preliminary efficacy study of RBX2660, was successfully completed in July 2014. An open label study means everyone enrolled in the study got the treatment and it is generally the first phase of a new product development program. The study demonstrated a success rate of 87% for those treated with no serious adverse events related to either the product or the method of delivery.
Rebiotix is currently exploring the feasibility of an oral formulation, RBX7455, for the prevention of C. diff.
In addition, Rebiotix is leveraging their years of knowledge and experience to develop MRT applications for other conditions that result from disruption of the gut microbiota.
For more information on Rebiotix and the PUNCH CD and PUNCH CD 2 studies go to:
Caution: Drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration.
In October of 2017 Finch merged with Crestovo to form Finch Therapeutics Group.
The PRISM 3 clinical study is for patients who have had a recurrence of Clostridium difficile infection (CDI or C. diff). The study is evaluating the safety and effectiveness of the study drug (CP101) to prevent recurrence of CDI compared to a placebo. The study is currently enrolling across the United States.
This clinical trial (CP101) is in Phase 2. For more information from
http://www.ClinicalTrials.gov click on the following link:
https://www.clinicaltrials.gov/ct2/show ... M+3&rank=3
The study drug, CP101, is a Full-Spectrum Microbiota™ investigational drug designed to deliver bacteria to the intestine. This bacteria may help overtake the surplus of C. diff. bacteria that cause CDI.
CP101 is encapsulated for oral administration. The powder is intended to be released from the capsules in the right part of your intestine where the bacteria may repopulate. This may aid in restoring the diverse community of bacteria found in the healthy human gut, which may prevent recurrence of C. diff..
Click here to learn more about PRISM 3(https://www.prism3trial.com/trial) and see if there is a study near you and if you are eligible.
CP101 drug products are in development and investigational at this time. No product has yet been approved by the U.S. Food and Drug Administration.
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DIFICID (fidaxomicin) is currently FDA approved to treat Clostridium difficile-associated diarrhea (CDAD) in adult patients 18 years of age and older.
Currently, clinical trials are ongoing to assess the efficacy and safety of DIFICID, in either a tablet and oral suspension formulation, in pediatric patients with CDAD. ** In addition, DIFICID is currently in clinical trials to determine the efficacy of use as a prophylaxis against CDAD in adult patients undergoing hematopoietic stem cell transplantation (HSCT).
XBiotech is a biotech company located in Austin, Texas and was founded on the concept of the “True Human Antibody”. Antibodies are specialized proteins, which are produced by the immune system. Their function is to bind to a very specific target, such as a virus or bacteria, and aid in the elimination of these targets by the immune system. Monoclonal antibodies were developed as a class of drug, which use the specific targeting function of the antibody to target substances that cause disease. Currently approved monoclonal antibodies however, are developed in the laboratory or in mice. XBiotech’s approach is to isolate antibodies that are present naturally in healthy human donors, and develop these into products that can be used to treat disease. We believe that antibodies isolated from humans, will be safer and will function better than so called antibodies marketed as “fully human”, which are in fact engineered.
Over the past decade, Clostridium difficile (C. diff) has emerged as a significant public health threat. In fact, the CDC has designated it as an “Urgent threat level.”
In October 2015, XBiotech announced it had set out to develop a first-in-class oral monoclonal antibody against C. diff infection. Just two weeks after this announcement, the Company reported it had already identified positive blood samples for anti-clostridium difficile antibodies after screening blood donations from healthy volunteers.
XBiotech’s plans to develop an antibody therapy that directly targets and neutralizes the bacteria. The Company intends to deliver the therapy orally, targeting C. diff in the gastrointestinal tract, where the antibody could reduce the bacteria’s ability to establish debilitating or life threatening infections.
Click on the XBiotech LOGO to the left to listen to the February 2016 XBiotech Podcast which introduces XBiotech, developer of True Human(TM) therapeutic antibodies. XBiotech has an exciting pipeline of product candidates in various areas of medicine. The Company recently announced the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile(C.difficile) infection. The Company will discuss the need for an effective C.difficile therapy, their novel approach to treating the disease as well as efficiency in their manufacturing technology. Join guests: Dr. Michael Stecher, Medical Director, Dr. Sushma Shivaswamy, Vice President of Research and Development, and Kelly Thornburg, Senior Vice President of Operations, as they discuss how XBiotech is pioneering a new era in the discovery and development of targeted antibodies therapeutics.
For more information please contact the Company by emailing email@example.com or calling 512-386-2900. http://www.xbiotech.com
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