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Clostridia, Cluster Xiva, Strain Relative Blautia Coccoides, Live

A new drug called VE202, containing live bacterial strains including Clostridia, Cluster XIVa, Strain Relative Blautia Coccoides, is being studied in a Phase 2 clinical trial for patients with mild to moderate ulcerative colitis. This randomized, double-blind, placebo-controlled study aims to evaluate the efficacy and safety of VE202 over an 8-week treatment period. The trial focuses on patients who have not previously received certain types of treatments for their condition.

Table of Contents

What is VE202?

VE202 is an innovative medication being studied for the treatment of mild to moderate ulcerative colitis. It is also known by its other name, JNJ-72537634.[1] Ulcerative colitis is a type of inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum.

This new drug is unique because it contains multiple strains of live bacteria, specifically designed to help restore balance to the gut microbiome. The gut microbiome refers to the trillions of microorganisms, including bacteria, that live in our digestive tract and play a crucial role in our overall health.

How VE202 Works

VE202 is a capsule that contains a mixture of live bacterial strains. These bacteria belong to various groups, including:[1]

  • Clostridia (Clusters XIVA and IV)
  • Bacilli (Cluster XVIII)

When you take VE202, these beneficial bacteria are introduced into your gut. The goal is to help restore a healthy balance of microorganisms in your intestines, which may help reduce inflammation and improve symptoms of ulcerative colitis.

Clinical Trial Details

VE202 is currently being studied in a Phase 2 clinical trial. This means that researchers are testing its effectiveness and safety in a larger group of people with mild to moderate ulcerative colitis.[1]

Key details of the study include:

  • It is a randomized, double-blind, placebo-controlled trial. This means that participants are randomly assigned to receive either VE202 or a placebo (a substance that looks like the medication but contains no active ingredients), and neither the participants nor the researchers know who is receiving which treatment.
  • The treatment period lasts for 8 weeks.
  • The main goal is to see if VE202 can improve the appearance of the colon lining when viewed through a flexible sigmoidoscopy (a procedure that allows doctors to examine the lower part of the colon) after 56 days of treatment.

Eligibility Criteria

To participate in this study, patients must meet certain criteria. Some key eligibility requirements include:[1]

  • Age: 18 to 75 years old
  • Diagnosed with ulcerative colitis for at least 3 months
  • Have active mild to moderate ulcerative colitis, as determined by specific scoring systems used by doctors
  • Have not previously received certain types of medications for ulcerative colitis, such as biologics or JAK inhibitors

There are also several factors that would exclude someone from participating, such as having Crohn’s disease, active infections, or recent use of antibiotics or probiotics.

Potential Benefits

While the effectiveness of VE202 is still being studied, researchers hope that it may offer several potential benefits for people with mild to moderate ulcerative colitis:[1]

  • Improved appearance of the colon lining, which could indicate reduced inflammation
  • Reduction in symptoms such as rectal bleeding
  • A new treatment option for those who haven’t responded well to other medications
  • A potentially safer alternative to some existing treatments, as it uses beneficial bacteria rather than drugs that suppress the immune system

Safety Considerations

As with any new medication, safety is a top priority in the VE202 clinical trial. The researchers are closely monitoring for any side effects or adverse reactions. Some important safety considerations include:[1]

  • The study excludes people with certain health conditions or those taking specific medications to minimize potential risks.
  • Participants are carefully screened and monitored throughout the study.
  • The trial includes a placebo group to help distinguish between effects caused by VE202 and those that might occur by chance.
  • The study is designed to look for any serious side effects or safety concerns related to VE202.

It’s important to note that VE202 is still an experimental treatment. While it shows promise, more research is needed to fully understand its effectiveness and safety for treating ulcerative colitis.

Aspect Details
Study Drug VE202 (containing live bacterial strains including Clostridia, Cluster XIVa, Strain Relative Blautia Coccoides)
Condition Mild to moderate ulcerative colitis
Study Type Phase 2, randomized, double-blind, placebo-controlled
Primary Objective Evaluate efficacy in terms of endoscopic response at Day 56
Treatment Duration 8 weeks
Key Inclusion Criteria Adults 18-75 years, UC diagnosis for at least 3 months, no prior biologic/JAK inhibitor/S1P modulator treatment
Key Exclusion Criteria History of Crohn’s disease, recent FMT or antibiotic use, active infections
Primary Endpoints Endoscopic response rate, treatment-related adverse events

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, including Clostridia, Cluster XIVa, Strain Relative Blautia Coccoides. It is designed to potentially help manage mild to moderate ulcerative colitis by modifying the gut microbiome, which plays a role in intestinal health and inflammation.
  • Who is eligible for this clinical trial? The trial is open to adults aged 18-75 with a documented diagnosis of mild to moderate ulcerative colitis for at least 3 months. Participants must not have previously received biologic agents, Janus kinase inhibitors, or sphingosine-1-phosphate modulators for UC treatment.
  • What is the main goal of this clinical trial? The primary objective is to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment. This is measured by a reduction of 1 point or more in the Mayo endoscopic subscore from baseline to Day 56.
  • How long does the treatment last in this trial? The treatment period in this trial lasts for 8 weeks (56 days). Participants will receive either VE202 or a placebo during this time.
  • What are some key exclusion criteria for this trial? Key exclusions include a history of Crohn's disease or indeterminate colitis, recent use of fecal microbiota transplantation (FMT), antibiotics, or probiotics, active infections, and allergies to VE202 or its components. Patients with active colonic dysplasia or primary sclerosing cholangitis are also excluded.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Blautia Coccoides, Live

  • Study on VE202 for Patients with Mild-to-Moderate Ulcerative Colitis

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Hungary Lithuania The Netherlands Poland

Glossary

  • Ulcerative Colitis (UC): A chronic inflammatory bowel disease that affects the lining of the large intestine (colon) and rectum, causing inflammation and ulcers.
  • Endoscopic Response: An improvement in the appearance of the colon lining as observed through a flexible tube with a camera (endoscope) inserted into the rectum.
  • Mayo Endoscopic Subscore: A scoring system used to assess the severity of ulcerative colitis based on the appearance of the colon during an endoscopic examination.
  • Microbiome: The collection of microorganisms, including bacteria, that live in the human body, particularly in the gut.
  • Placebo: An inactive substance that looks like the drug being tested but contains no active medication, used to compare the effects of the real drug.
  • Randomized, Double-Blind Study: A type of clinical trial where participants are randomly assigned to receive either the study drug or a placebo, and neither the participants nor the researchers know who is receiving which treatment.
  • Biologic Agent: A type of medication made from living organisms or their products, often used to treat inflammatory conditions like ulcerative colitis.
  • Janus Kinase (JAK) Inhibitor: A class of medications that work by blocking specific enzymes involved in the inflammatory process.
  • Sphingosine-1-Phosphate (S1P) Modulator: A type of medication that affects how immune cells move through the body, potentially reducing inflammation in conditions like ulcerative colitis.
  • Fecal Microbiota Transplantation (FMT): A procedure in which fecal matter from a healthy donor is transferred to a recipient to help restore a healthy balance of gut bacteria.

References

  1. http://clinicaltrials.eu/trial/study-on-ve202-for-patients-with-mild-to-moderate-ulcerative-colitis/