Tag Archives: C Diff Clinical Trials

Rebiotix, Inc. PUNCH CD 2 Study – Second Clinical Trial Initiated

Update

24 November 2014

Rebiotix has initiated our second clinical trial (PUNCH CD 2) focusing on the treatment of recurrent C. difficile infection!

REBIOTIX, INC.

The PUNCH CD 2 study is a Phase 2B randomized controlled trial to assess the effectiveness and safety of RBX2660 (microbiota suspension) for the treatment of recurrent               Clostridium difficile (C. diff.)  infection.

About the Study   The PUNCH CD 2 study is the first multicenter prospective, multicenter, randomized, placebo-controlled, double-blind study of a microbiota restoration therapy. It has been designed to provide the highest quality of evidence to-date about this non-antibiotic approach to treating recurrent C. diff. infection.

Approximately 117 patients at over 20 sites in the US and Canada are expected to be enrolled in study.

Patients will be randomized into three different study groups: one group will receive two enemas containing RBX2660; another group will receive two enemas without the active drug; and the third group will receive one enema with RBX2660 and one without.  If a patient’s C. diff. infection reoccurs before 8 weeks after treatment, he or she may be eligible to crossover to receive active treatment with RBX2660.

All patients will be followed for 24 months after treatment.

Further Study Details

For more information on the study you may:

Find Out if You Could be Eligible

A physician participating in the PUNCH CD 2 study will determine if you are eligible to participate in the study. However, you can take a brief survey (less than 1 ½ minutes to complete) to learn if you meet the major study eligibility criteria.

How to Enroll as a Participant

If a study physician thinks you may be a good candidate, you will be given complete information about the study including the responsibilities for participation. You can find out if there is a study site near you by reviewing the clinical study site locations for PUNCH CD 2.


Caution: New Drug – Limited by Federal (or United States) law to investigational use.

 

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

C. difficile Prevention; Synthetic Biologics Safe-to-Proceed Under IND to Initiate Clinical Trials of SYN-004

Phase 1a and 1b Trials to Use SYN-004 to Protect Microbiome; Intended to Prevent Overgrowth of Potentially Deadly C. difficile Bacteria

Synthetic Biologics, Inc., a developer of pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome, today announced that its Investigational New Drug (IND) application which was submitted to the U.S. Food and Drug Administration (FDA) in October will be proceeding into clinical trials for the development of the Company’s oral beta-lactamase enzyme SYN-004 for the prevention of Clostridium difficile (C. difficile) infection (CDI), antibiotic-associated diarrhea (AAD) and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving intravenous (IV) beta-lactam antibiotic therapy. Synthetic Biologics plans to begin Phase 1a and 1b clinical trials shortly, with topline data expected to be reported before year-end.
 

“We are pleased the FDA completed the 30-day review of our IND and to be initiating clinical trials of the first potential point-of-care preventative therapy for C. difficile, the CDC’s top-ranking public health threat,” said Jeffrey Riley, Chief Executive Officer of Synthetic Biologics. “Taking immediate and aggressive action to develop a therapy that can prevent C. difficile before it starts is critical in addressing this pervasive and life-threatening infection, and IND activation for SYN-004 is a key step toward the development and eventual commercialization of therapy to protect the millions of at risk U.S. patients.”

SYN-004 is Synthetic Biologics’ oral drug candidate designed to be the first and only prophylactic treatment intended to prevent the development of C. difficile infection, by binding with and neutralizing certain common IV beta-lactam antibiotics in the gut. SYN-004 is intended to block the unintended harmful effects of antibiotics within the gastrointestinal (GI) tract, maintaining the natural balance of the bacterial flora (gut microbiome), potentially preventing the 1.1 million C. difficile infectionsii and 30,000 C. difficile-related deathsiii in the U.S. each year.

Synthetic Biologics has met each milestone for its C. difficile program leading up to the IND submission to the agency. Clinical drug manufacturing of SYN-004 under cGMP guidelines to support Synthetic Biologics’ planned Phase 1 and 2 clinical trials was completed on time to support the IND submission and clinical trial initiation. Most recently, the U.S. Patent and Trademark Office issued a Notice of Allowance for the first composition of matter patent application directly pertaining to SYN-004 in the U.S., which carries a patent term to at least 2031.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a clinical-stage biotechnology company developing pathogen-specific therapies for serious infections and diseases, with a focus on protecting the microbiome. The Company is developing an oral biologic to protect the gastrointestinal (GI) microflora from the effects of intravenous (IV) antibiotics for the prevention of C. difficile infection, an oral treatment to reduce the impact of methane producing organisms on constipation-predominant irritable bowel syndrome (C-IBS) and a monoclonal antibody combination for the treatment of Pertussis being developed in collaboration with Intrexon Corporation (XON). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

For  the complete Press Release article – click on the following link:

https://ca.finance.yahoo.com/news/synthetic-biologics-safe-proceed-under-115700305.html


C. difficile infection – Prevention – Da Volterra presents promising results of DAV-132 compound

* In The News 13 May 2014 *

Da Volterra, a leading biopharmaceutical company in the field of bacterial resistance, announces today very promising new results about DAV132 in the prevention of the side effects of antibiotics and the occurrence of severe Clostridium difficile infections. The Company presents two posters at ECCMID 2014 (the European Conference of Microbiology and Infectious Diseases) taking place in Barcelona on May 10-13, 2014.

With a novel and unique mechanism of action, DAV132 is a product candidate aiming at protecting the intestinal flora from the side effects of administered antibiotics, hence preventing Clostridium difficile infections. This pathogenic bacterium causes serious and potentially lethal gastro-intestinal infections. To this end, DAV132 captures the antibiotic residues in the digestive tract which are at the origin of the alterations of the intestinal flora, while maintaining the efficacy of the antibiotic treatment. As a consequence the flora disruption adverse effect is avoided.

The CL1001 study, a phase I clinical trial performed in the spring 2013 at the Medicine University of Greifswald (Germany) with 18 healthy volunteers, showed the expected targeted delivery of DAV132. The results demonstrate that DAV132 effectively exerts its adsorbing effect in the ileum and the colon, whereas DAV132 does not interfere upstream with antibiotics in the small intestine. Antibiotic treatments given together with DAV132 would thus be optimized, DAV132 reducing the alterations of the flora and their consequences such as Clostridium difficile infections or the emergence of resistant bacteria.

A preclinical study performed in the reference hamster model of Clostridium difficile infections evidenced the preventive effect of DAV132. Animals treated with moxifloxacin only (an antibiotic) showed 100% mortality (no survivor after 7 days) in the experiment. Interestingly, animals treated with moxifloxacin and DAV132 during 5 days are protected from the lethal impacts of Clostridium difficile. The protective effect of DAV132 is dose-dependent and a total protection is reached at the highest doses. This study in a predictive model of the disease illustrates the protective effects of DAV132, co-administered with an antibiotic treatment, against Clostridium difficile infections.

The detailed results are presented in two posters at the ECCMID conference (European Congress of Clinical Microbiology and Infectious Diseases) taking place in Barcelona on the 10-13 May, 2014.

Florence Séjourné, CEO of Da Volterra, declared: We are particularly proud to present these results to the scientific community, illustrating the very innovative and unique profile of DAV132. The control of Clostridium difficile infections and antibiotic resistance are major public health challenges. We look forward to advancing the development of DAV132, and are convinced that Da Volterra is well positioned to push forward its innovative product pipeline to meet these urgent medical needs.

Source: http://www.davolterra.com/

Synthetic Biologics SYN-004 Oral Enzyme for C. difficile prevention

* In the news  31 March 2014 *
Prevention of C. difficile (C. diff.) Infections – SYN-004 Oral Enzyme

Manufacturing is underway to support preclinical and clinical trials of SYN-004,  Synthetic Biologics’ lead anti-infective product candidate, which is believed to be the first and only therapy designed to potentially prevent the devastating effects of C. diff. The Center for Disease Control and Prevention (CDC) has classified C. diff as an “urgent public health threat”[ii], surpassing Methicillin-resistant Staphylococcus aureus (MRSA) as the number one hospital-acquired infection in the United States. C. diff is a multidrug-resistant bacterium that infects 1.1 million U.S. patients annually[iii]. Plans remain on schedule to initiate a 28-day bridging toxicology study of the Company’s second generation candidate late in the second quarter of 2014. Synthetic Biologics expects to file an IND and to initiate Phase Ia and Ib clinical trials during the second half of 2014 for its C. diff program.

 

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

http://www.prnewswire.com/news-releases/synthetic-biologics-reports-year-end-2013-financial-results-and-operational-update-253172521.html

 

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

Rebiotix, Inc. Completes Enrollment in Phase II Clinical Trial

In The News:

Rebiotix Inc. has announced that it has completed enrollment in the PUNCH CD Phase 2 clinical trial of RBX2660 (microbiota suspension) for the treatment of recurrent Clostridium difficile-associated diarrhea (CDAD). The study is the first of its kind prospective, multi-center clinical study to evaluate a non-antibiotic, live microbial drug product for the treatment of recurrent CDAD conducted using the same protocol at all sites.

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

http://finance.yahoo.com/news/rebiotix-completes-enrollment-phase-2-142400625.html?soc_src=mediacontentstory

 

 

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