CLICK ON THE LOGO TO BE REDIRECTED TO LISTEN TO THE BROADCAST
Listen in to the live broadcast at 10a PT, 11a MT, 12p CT, 1p ET 6p UK
“C. diff. Spores and More,” Global Broadcasting Network – innovative and educational interactive healthcare talk radio program discusses
The Role of the Microbiome in Health and Disease: The Basics
With Our Guest
Dr. Matthew Henn, Senior Vice President, Head of Drug Discovery and Bioinformatics
Matthew Henn is the Senior Vice President and Head of Drug Discovery & Bioinformatics of Seres Therapeutics, Inc. He has more than 16 years of combined research experience in microbial ecology, genomics, and bioinformatics that spans both environmental and infectious disease applications.
Dr. Henn’s research has focused on the development, implementation, and application of genomic technologies in the area of microbial populations and their metabolic functions. Prior to joining Seres, he was the Director of Viral Genomics and Assistant Director of the Genome Sequencing Center for Infectious Diseases at the Broad Institute of MIT and Harvard.
Join us on Tuesday, July 19th as Dr. Henn provides the foundation educational information about the microbiome by answering the fundamental questions of what is it, why is it important, how does it impact patients with C. difficile infections, and what are the possibilities of the microbiome as a therapeutic target for future drugs. This interview will solely be with Dr. Matthew Henn, Senior Vice President and Head of Drug Discovery & Bioinformatics at Seres Therapeutics, Inc,.
Seres Therapeutics is a leading microbiome therapeutics company dedicated to creating a new class of medicines to treat diseases resulting from imbalances in the microbiome. These first-in-class drugs, called Ecobiotics®, are ecological compositions of beneficial organisms that are designed to restore a healthy human microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.
“C. diff. Spores and More “ Global Broadcasting Network spotlights world renowned topic experts, research scientists, healthcare professionals, organization representatives,C. diff. survivors, board members, and C Diff Foundation volunteers who are all creating positive changes in the C. diff. community worldwide.
Through their interviews, the C Diff Foundation mission will connect, educate, and empower many worldwide.
Questions received through the show page portal will be reviewed and addressed by the show’s Medical Correspondent, Dr. Fred Zar, MD, FACP, Dr. Fred Zar is a Professor of Clinical Medicine, Vice Head for Education in the Department of Medicine, and Program Director of the Internal Medicine Residency at the University of Illinois at Chicago. Over the last two decades he has been a pioneer in the study of the treatment of Clostridium difficile disease and the need to stratify patients by disease severity.
Pick a disease or disorder, and somebody, somewhere, has said that a probiotic supplement—an over-the-counter, unregulated pill usually filled with a single strain of friendly gut bacteria—might cure it, whether it’s cancer, obsessive-compulsive disorder, or a yeast infection.
But there’s very little evidence that probiotic supplements do any good. “There’s a lot of promise here but not a lot of proof yet,” said Cliff McDonald, associate director for science at the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion.
Half a million people a year are infected with C. diff in the U.S., the CDC estimates, with 29,000 annual deaths related to the diarrheic bacterium. More than 65 percent of C. diff infections involve exposure in a health-care facility, according to a 2015 study, creating more than $4.8 billion in excess health-care costs at acute-care facilities alone.
C. diff. Treatments On The Horizon:
To Learn More About ALL C. diff. Clinical Trials In Progress Click On The Following Link:
Seres Therapeutics, a microbiome-based biopharmaceutical company in Cambridge, Mass., is developing a pill, subject to a rigorous approval process under the Food and Drug Administration, to tackle recurrent Clostridium difficile. (The digestive system’s microbiome is the community of healthy gut bacteria that normally reside in the body.)
Seres aims to put the science behind a proven treatment of recurrent C. diff, fecal transplants, in a pill, which wouldn’t require a colonoscopy. Like probiotic supplements, it’s a gut bacteria product. Unlike the supplements, by the time it’s available it will have gone through the FDA wringer. It will contain about 50 strains of bacteria proven effective in treating C. diff and will require a doctor’s prescription.
Recurrent C. diff is an obvious entry point for Seres, said Chief Executive Officer Roger Pomerantz. “We asked, what is the lowest-hanging fruit?” But it’s hardly the end. The company has built a microbiome library of 14,000 strains of human bacteria it hopes will help it treat a range of diseases, eventually without needing feces at all. Seres has embarked on the research with some pretty lofty goals, including finding treatments for obesity, liver disease, and cancer. It has partnerships with Massachusetts General Hospital, the Mayo Clinic, Memorial Sloan Kettering Cancer Center, and other respected medical institutions. “We will figure out exactly what’s wrong with the microbiome, design a drug, and then pull the organisms out with our library, never touching a human donation,” Pomerantz said. Seres’s lead product candidate, SER-109, will treat recurrent C. diff with four capsules taken orally instead of with transplants. While fecal matter is the raw material for the pills, the final product consists only of the spores necessary to treat the infection, which will have been extracted and purified. SER-109 is expected to become the first oral microbiome therapy approved by the FDA, though Seres declined to predict exactly when it will arrive. Results from the latest trials are due by midyear, and Phase 3 trials are scheduled to follow later in the year. Seres hopes to follow up quickly with SER-287, a drug to treat ulcerative colitis, which could be the first microbiome drug to treat a chronic disease, and SER-262, to treat primary C. diff before it turns into the recurrent kind.
Other companies are racing to collect enough data for FDA approval, but right now Seres, which is publicly traded, looks to be the one to beat. “Seres is probably going to be the first one that’s going to knock at the FDA’s door,” said Mohan Iyer, chief business officer at Second Genome, a microbiome company studying how to treat disease with the compounds produced by gut bacteria instead of the gut bacteria themselves.
“SER-109 is poised to be first-in-class among fecal microbiota transplant-derived drugs,” Joseph Schwartz, an analyst at Leerink Partners, wrote in a May report. The report says the latest trial results “wowed the Street” but warns that the company could still be held back by “disappointing clinical data” and obstacles in the regulatory process.
Another top contender is Rebiotix. Its RBX2660 is also designed to treat recurrent C. diff but, unlike SER-109, is administered with an enema; an oral version is in development. The treatment also differs significantly from Seres’s in formulation, including thousands of kinds of microbes from the donor’s stool, compared with SER-109’s 50 or so, as many as could be preserved and some of which haven’t even been identified.
“We make sure we have a minimum concentration of certain kinds that we know the patients lack,” CEO Lee Jones said. “But we don’t identify all of them. There’s no way to do that.” A recent study estimated that 1014 bacteria are in the human gut, most of which have never been isolated. Jones said the drug could hit the market by 2018.
The medications have been shown to be similarly effective—with no C. diff-associated diarrhea for 29 of 30 of Seres’s patients and 27 of 31 of Rebiotix’s, in the companies’ latest results—and equally safe. Adverse reactions for both are limited to such problems as moderate diarrhea and abdominal cramping, which could be from the C. diff itself. Both have been designated as “breakthrough therapies” by the FDA, allowing for an expedited approval process, and both are likely soon to provide an at-home alternative to fecal transplants.
Point Of View:
“I don’t know who is going to make it across the line first,” said Gail Hecht, director of gastroenterology and nutrition at Loyola University Medical Center and chairwoman of the American Gastroenterological Association for Gut Microbiome Research & Education. Hecht has attended a Seres advisory board meeting but doesn’t have a financial interest in the company. “It is indeed a race,” she said.
Seres does have at least one distinct market advantage. “Patients have different preferences,” Hecht observes, but “in general, people don’t particularly like enemas.”
Human Fecal Transplants:
For nearly two thousand years, doctors have looked to this unlikeliest of places for medicine. One of the earliest documented applications is from the fourth-century Chinese medical doctor Ge Hong, whose “yellow soup” recipe to treat diarrhea included a healthy person’s dried or fermented feces. Sixteen hundred years later, in 1958, patients infected with C. diff received the first known human fecal transplants.
Stool Bank Information:
Today the effectiveness of fecal transplants (formally known as fecal microbiota transplants) to treat recurrent C. diff is supported by a long list of studies, with researchers attributing the results to the restoration of the microbiome. OpenBiome, a nonprofit stool bank, shipped 1,828 treatments in 2014, a number that ballooned to 7,140 treatments in 2015 and looks to be eclipsed this year, with 4,323 treatments shipped to its clinical partners through May 31. And these numbers don’t take into account the transplants performed through directed fecal donations.
“Ecobiotics: A Novel Approach to Recurrent C. difficile infections”
Tuesday, February 23rd — Live Broadcast
PODCAST IS NOW AVAILABLE, PLEASE CLICK ON THE SERES THERAPEUTICS LOGO BELOW
10 a.m. Pacific Time,, 11 a.m. Mountain Time,
12 p.m. Central Time, 1 p.m. Eastern Time
We invite you to listen to the live broadcast and archived programs by clicking on the
Cdiff radio logo displayed below:
This episode introduces Seres Therapeutics, a leading microbiome therapeutics company, which recently published in the Journal of Infectious Diseases positive results from an open-label Phase 1b/2 study of SER-109 for the treatment of patients with recurrent C. difficile infections (CDI). Seres Therapeutics is creating a new class of medicines to treat diseases resulting from functional deficiencies in the microbiome, a condition known as dysbiosis.
TO LISTEN TO THIS EPISODE – PLEASE CLICK ON THE SERES THERAPEUTICS LOGO BELOW
New insights into the human microbiome are fundamentally reshaping how we understand and treat a wide range of diseases, creating new possibilities for patients not served by current therapeutic approaches. Ecobiotics are ecological compositions of beneficial organisms that are designed to reestablish a healthy microbiome. The discovery efforts at Seres Therapeutics currently span metabolic, inflammatory, and infectious diseases.
Dr. David Cook, Ph.D., Executive Vice President of R&D and Chief Scientific Officer
Dr. Michele (Shelley) Trucksis, Ph.D., M.D., Executive Vice President and Chief Medical Officer
As we discuss the microbiome, CDI, clinical studies SER-109, Probiotics, ECOSPOR, and much more
C. diff. Spores and MoreGlobal Broadcasting Network – producing educational programs dedicated to C. difficile Infections and more — brought to you by VoiceAmerica and sponsored by Clorox Healthcare
Seres Therapeutics Disclaimer:
“This interview will include forward-looking statements on Seres Therapeutics’ current expectations and projections about future events. These statements are based upon current beliefs, expectations and assumptions, and are subject to a number of important risks and uncertainties, including those set forth in Seres Therapeutics’ filings with the SEC, many of which are difficult to predict. Actual results may differ materially from such statements. The information included in this interview is provided only as of the date of this interview, and Seres Therapeutics undertakes no obligation to update any forward-looking statements stated in this interview on account of new information, future events, or otherwise, except as required by law. Seres Therapeutics has provided financial support to the C Diff Foundation.”
Nestlé Health Science has signed an exclusive agreement outside of the United States and Canada to support the potential future commercialisation of Seres Therapeutics ‘ novel ‘microbiome therapeutics’.
The aim is to treat Inflammatory Bowel Disease (IBD) and Clostridium difficile (C.diff), an intestinal infection caused by the C.diff bacteria that can be life-threatening in some cases.
Nestlé Health Science will invest USD 120 million upfront to support Seres’ ‘Ecobiotics’, a new class of biological drugs based upon microbial organisms. These target the microbiome – the 100 trillion microorganisms that live in the body.
Scientific has noted that research increasingly links an unhealthy or unbalanced microbiome to a range of health conditions, including IBD and C.diff.
Seres Therapeutics designs Ecobiotic® drugs using their proprietary microbiome therapeutics platform. This technology gives them insights into the microbiome associated with health and disease states, allowing them to create effective therapies that are designed to disrupt unhealthy microbial ecological networks and that catalyze the establishment of healthy ones. Ecobiotic® drugs are designed to rapidly and safely treat serious diseases by positively reshaping the microbiome.
click on the graphic above to be directed to the Seres Therapeutics website.
*Please note – The C Diff Foundation does not endorse this product or any product and this posting is strictly for informational purposes only.