Tag Archives: FMT pill

Recurrent C. difficile Infection; Seres Health Plans To Use Funding To Advance SER-109, Into Phase 3 Clinical Trials

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Seres Health, Cambridge, MA based, a contender in the haute field of microbiome therapeutics, just hauled in a $48 million Series C round.

The startup’s developing biologics that target recurrent C.difficile infections.

 

 

The company plans to use the funding to advance its lead candidate, SER-109, into Phase 3 clinical trials. If approved, Seres’ therapeutic line – called Ecobiotic – will be the first oral microbiome-related therapeutic that receives the regulatory go-ahead.

The Ecobiotic system works by “augmenting the biology of the microbiome,” Seres said. In September it released results from its earlier SER-109 trial, in which 29 of the study’s 30 patients were completely cured of their C. dificile infections over the course of 8 weeks. The patients received oral doses of Seres’ microbiome “spores” – that is, precursors to “good” gut bacteria that mature into disease-fighting agents. They’ve been isolated from human fecal matter, then delivered in pill-form to the patient – a promising approach given the growing bacterial resistance to antibiotics.

In addition to treating clostridium-related disease, Seres’ pipeline pursues other as-yet-unnamed indications in the metabolic, inflammatory and infectious disease spaces.

Seres Health was launched in 2012 by Flagship Ventures. This past June, it teamed up with Mayo Clinic  for an exclusive research partnership.

 

 

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

Mayo Clinic has developed a delayed-release pill, dubbed SER-109 – benefits of a FMT

* In the news *

http://www.foxnews.com/health/2014/08/26/grossed-out-by-fecal-transplants-now-there-pill-instead/

 

Fecal microbiota transplants (FMTs) are exactly what they sound like. They involve taking feces from a healthy person and putting them into the body of a sick patient to strengthen the community of bacteria that live in the patient’s gut.

FMTs are very effective at curing stubborn infections with Clostridium difficile (C. diff). The deadly bacteria cause 500,000 illnesses and 14,000 deaths each year in the United States. Small studies have shown that FMTs can cure about 90 percent of serious C. diff infections. They have been so successful that scientists are testing the transplants for other conditions, such as irritable bowel syndrome.

However, FMTs have their downsides. They’re invasive, they can spread disease, and — let’s face it — they’re gross.

What if patients could get the benefits of an FMT without the “ick factor”? A team led by researchers at the Mayo Clinic has developed a delayed-release pill, dubbed SER-109. Research suggests that it may be just as effective as a traditional transplant.

How Does the Pill Work?

In a trial of 15 patients with multiple flare-ups of C. diff infection, SER-109 cured all 15 within eight weeks. At the end of the trial, none of the patients had diarrhea, the hallmark of C. diff infection. All tested negative for the bacteria.

“The results of the study were not surprising and we were expecting a high cure rate,” lead study author Dr. Sahil Khanna of the Mayo Clinic told Healthline. “Previous studies involving conventional fecal transplant from the upper gut have demonstrated good success rates.”

Doctors think that giving patients large doses of antibiotics triggers C. diff infections. Antibiotics destroy the normal, helpful gut bacteria that help the body fight harmful microbes like C. diff. To cure the infection, doctors must reintroduce the good bacteria the patient has lost.

The pill required far fewer live bacteria than a traditional transplant. Even with fewer bacteria to re-seed the patients’ guts, the researchers confirmed that the pill quickly restored bacterial diversity.

Khanna, a gastroenterologist, said that the delayed-release capsules allowed the bacteria to survive the acidity and enzymes in the upper gastrointestinal tract and make it into the patient’s lower gut.

*To read article in its’ entirety click on the link above*