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5 mei 2023: Bron: FDA

De Federal Drug Administration (FDA) heeft VOWST, een pil met goede microbiotica en in plaats van een poeptransplantatie, goedgekeurd in het voorkomen van een recidief van Clostridioides difficile infectie (CDI) bij personen van 18 jaar en ouder, na antibacteriële behandeling voor terugkerende CDI.

Na 8 weken waren er in een gerandomiseerde studie in de VOWST-groep aanzienlijk minder recidieven dan in de controlegroep, te weten 12,4 versus 39,8 procent.

De FDA-goedkeuring van VOWST was gebaseerd op een gerandomiseerde klinische studie en een open-label klinische studie. In de gerandomiseerde studie ECOSPORIII waarin 89 deelnemers Vowst kregen en 93 een placebo kregen, was het recidief van infectie met de pil na acht weken lager, namelijk 12,4 procent voor de medicatiegroep versus 39,8 procent voor de placebogroep.
Een andere analyse van 90 patiënten die VOWST kregen, vergeleken met 92 patiënten die een placebo kregen, liet wel zien dat bijwerkingen als een opgeblazen gevoel, vermoeidheid, obstipatie, koude rillingen en diarree konden voorkomen.

In aanmerking komende patiënten van 18 jaar en ouder nemen dagelijks vier capsules Vowst gedurende drie opeenvolgende dagen. Hoewel donoren en hun ontlasting worden gescreend op ziekteverwekkers voordat de ontlasting wordt verwerkt voor de medicatie, bestaat het risico dat iemand door de pil ziek kan worden, merkt de FDA op. VOWST kan ook voedselallergenen bevatten. 

De goedkeuring van de FDA is in dit eerste artikel te lezen, daaronder het originele studierapport: 

FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection

Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the prevention of recurrence of Clostridioides difficile (C. difficile) infection (CDI) in individuals 18 years of age and older, following antibacterial treatment for recurrent CDI. 

“Today’s approval provides patients and healthcare providers a new way to help prevent recurrent C. difficile infection,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a fecal microbiota product that can be taken orally is a significant step forward in advancing patient care and accessibility for individuals who have experienced this disease that can be potentially life-threatening.”

CDI, caused by the bacterium C. difficile, is one of the most common healthcare-associated infections in the United States and is associated with 15,000 to 30,000 deaths annually. The human intestinal tract contains millions of microorganisms, often referred to as the “gut flora," or "gut microbiome." Certain situations, such as taking antibiotics to treat an infection, may change the balance of microorganisms in the gut, allowing C. difficile to multiply and release toxins causing diarrhea, abdominal pain and fever, and in some cases, organ failure and death. Other risk factors that can increase the risk of CDI include age over 65 years, hospitalization, nursing home residency, a weakened immune system and/or a previous history of CDI. After recovering from CDI, individuals may get the infection again—often multiple times—a condition known as recurrent CDI. The risk of additional recurrences increases with each infection and treatment options for recurrent CDI are limited. The administration of fecal microbiota is thought to facilitate restoration of the gut flora to prevent further episodes of CDI.

The dosing regimen of Vowst is four capsules taken once a day, orally, for three consecutive days. Vowst contains live bacteria and is manufactured from human fecal matter that has been donated by qualified individuals. Although the donors and donated stool are tested for a panel of transmissible pathogens, Vowst may carry a risk of transmitting infectious agents. It is also possible for Vowst to contain food allergens; the potential for Vowst to cause adverse reactions due to food allergens is unknown.

The safety of Vowst was evaluated in a randomized, double-blind, placebo-controlled, clinical study and an open-label clinical study conducted in the U.S. and Canada. The participants had recurrent CDI, were 48 to 96 hours post-antibacterial treatment and their symptoms were controlled. Across both studies, 346 individuals 18 years of age and older with recurrent CDI received all scheduled doses of Vowst. In an analysis among 90 Vowst recipients, when compared to 92 placebo recipients, the most commonly reported side effects by Vowst recipients, which occurred at a greater frequency than reported by placebo recipients, were abdominal bloating, fatigue, constipation, chills and diarrhea. 

The effectiveness of Vowst was evaluated in the randomized, placebo-controlled clinical study in which 89 participants received Vowst and 93 participants received placebo. Through 8 weeks after treatment, CDI recurrence in Vowst-treated participants was lower compared to placebo-treated participants (12.4% compared to 39.8%). 

The application was granted Priority Review, Breakthrough Therapy and Orphan designations. 

The FDA granted approval of Vowst to Seres Therapeutics Inc.

Abstract

Background: Current therapies for recurrent Clostridioides difficile infection do not address the disrupted microbiome, which supports C. difficile spore germination into toxin-producing bacteria. SER-109 is an investigational microbiome therapeutic composed of purified Firmicutes spores for the treatment of recurrent C. difficile infection.

Methods: We conducted a phase 3, double-blind, randomized, placebo-controlled trial in which patients who had had three or more episodes of C. difficile infection (inclusive of the qualifying acute episode) received SER-109 or placebo (four capsules daily for 3 days) after standard-of-care antibiotic treatment. The primary efficacy objective was to show superiority of SER-109 as compared with placebo in reducing the risk of C. difficile infection recurrence up to 8 weeks after treatment. Diagnosis by toxin testing was performed at trial entry, and randomization was stratified according to age and antibiotic agent received. Analyses of safety, microbiome engraftment, and metabolites were also performed.

Results: Among the 281 patients screened, 182 were enrolled. The percentage of patients with recurrence of C. difficile infection was 12% in the SER-109 group and 40% in the placebo group (relative risk, 0.32; 95% confidence interval , 0.18 to 0.58; P<0.001 for a relative risk of <1.0; P<0.001 for a relative risk of <0.833). SER-109 led to less frequent recurrence than placebo in analyses stratified according to age stratum (relative risk, 0.24 [95% CI, 0.07 to 0.78] for patients <65 years of age and 0.36 [95% CI, 0.18 to 0.72] for those ≥65 years) and antibiotic received (relative risk, 0.41 [95% CI, 0.22 to 0.79] with vancomycin and 0.09 [95% CI, 0.01 to 0.63] with fidaxomicin). Most adverse events were mild to moderate and were gastrointestinal in nature, with similar numbers in the two groups. SER-109 dose species were detected as early as week 1 and were associated with bile-acid profiles that are known to inhibit C. difficile spore germination.

Conclusions: In patients with symptom resolution of C. difficile infection after treatment with standard-of-care antibiotics, oral administration of SER-109 was superior to placebo in reducing the risk of recurrent infection. The observed safety profile of SER-109 was similar to that of placebo. (Funded by Seres Therapeutics; ECOSPOR III ClinicalTrials.gov number, NCT03183128.).

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