The first drug of fecal bacteria transplantation is on the way?

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The first drug of fecal bacteria transplantation is on the way?

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The first drug of fecal bacteria transplantation is on the way?

The phase 3 clinical trial of intestinal flora drug was listed on NEJM, and the first fecal bacteria transplantation drug is coming?

Clostridium difficile infection (CDI) refers to the imbalance of intestinal microecology caused by the proliferation of Clostridium difficile in the human intestinal tract, and causes diarrhea, pseudomembranous colitis, toxic megacolon and other diseases.

The cause of its infection is closely related to the abuse of antibiotics. Long-term use of antibiotics will reduce the intestinal flora of the human body, while the drug-resistant Clostridium difficile will multiply in large numbers, which will eventually lead to the imbalance of the flora and cause diseases.

In this case, microbial therapy company Seres Therapeutics has developed a fecal microcapsule , SER-109 , which consists of 50 bacterial spores from the Firmicutes phylum extracted and purified from the gut flora of healthy people An investigational microbiome therapeutic administered orally in capsule form to treat Clostridium difficile infection .

On January 20, 2022, the results of the Phase 3 clinical trial of the SER-109 therapy were published in the New Ingra Journal of Medicine (NEJM) . The paper is titled: SER-109, an Oral Microbiome Therapy for Recurrent Clostridioides difficile Infection

Clinical trial results showed that oral SER-109 significantly reduced the recurrence of C. difficile infection in patients following standard-of-care antibiotic treatment .

This fecal bacteria capsule , named SER-109 , is composed of microorganisms extracted and screened from human feces.

Faeces from pre-screened healthy donors are first treated with ethanol, which kills many microorganisms such as viruses, fungi and bacteria, leaving behind the bacterial spores of Firmicutes.

They can compete with C. difficile in the gut to occupy space, food and carbon sources for C. difficile, and they also change the composition of bile acids in the gut, making the environment inhospitable to C. difficile, thereby inhibiting C. difficile bacteria, restore intestinal health ecology.

This is a phase 3, double-blind, randomized, placebo-controlled clinical trial in patients with 3 or more episodes of C. difficile infection (including eligible acute episodes) who, after standard antibiotic therapy, receive SER-109 microbiome therapy or placebo (4 capsules per day for 3 days) .

The primary efficacy objective was to show the advantage of SER-109 compared to placebo in reducing the risk of C. difficile infection recurrence within 8 weeks of treatment.

Diagnosis was made by toxin testing at the start of the trial and randomization was performed according to age and antibiotic medication received, and safety, microbiome engraftment and metabolite profiling were also performed.

Of the 281 patients screened, 182 were enrolled. Results of the clinical trial showed that the recurrence rate of C. difficile infection was 12% in the SER-109 group compared to 40% in the placebo group. In patients whose symptoms of C. difficile infection resolved after treatment with standard-of-care antibiotics, oral SER-109 significantly outperformed placebo in reducing the risk of recurrent infection, and observed side effects similar to placebo.

Founded in 2010, Seres Therapeutics aims to revolutionize the treatment of various diseases by manipulating the function of the human microbiome.

The company was listed on Nasdaq in May 2015 and was the first public company in the field of microbiome drug research and development.

At present, Seres has a total of 5 R&D pipelines, of which SER-109 for the treatment of Clostridium difficile infection has the fastest progress, and the clinical phase 3 has been completed .

A therapy for infection and graft-versus-host disease (GvHD) is in preclinical stage, and a therapy for melanoma is in preclinical stage.

The SER-109 therapy, in fact, has an ill-fated fate. It worked well in Phase 1 clinical trials and was awarded “Breakthrough Therapy” certification and “Orphan Drug” designation by the FDA in 2015. Seres also uses this to log on to Nasdaq.

However, the follow-up phase 2 clinical trial failed miserably, and its treatment effect was not significantly different from placebo.

Since then, after discussions with the FDA, Seres recruited more patients for Phase 3 clinical trials.

The Phase 3 clinical trial has achieved remarkable results. Seres plans to submit a marketing application for SER -109 to the FDA in the middle of this year.

SER -109 is expected to become the first gut microbiome drug approved by the FDA for marketing.

In addition to Seres Therapeutics , several other microbial therapy companies have followed, with Rebiotix Inc. announcing positive Phase 3 clinical trials of its gut microbial therapy for Clostridium difficile infections last year;

Finch Therapeutics announcing its gut microbial freeze Successful Phase 2 clinical trial of dry drug for Clostridium difficile infection ;

Vedanta Biosciences also announced the completion of a Phase 2 clinical trial of the microbiome for Clostridium difficile infection.

In addition, Wuweijun , a leading domestic gut microbiome therapy company , received an IND application from the FDA in September 2021, and will conduct a clinical trial of gut microbiota transplantation for graft-versus-host disease (GvHD) , which is also the first FDA-approved clinical trial in Asia.

Clinically approved fecal microbiota transplantation (FMT) drug, and the first microbial drug in China to receive FDA clinical approval .

References :
https://www.serestherapeutics.com/our-programs/
https://www.nejm.org/doi/full/10.1056/NEJMoa2106516

The first drug of fecal bacteria transplantation is on the way?

(source:internet, reference only)

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