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Clostridia, Cluster Xiva, Strain Relative Muricomes Sp000509105, Live

A Phase 2 clinical trial is underway to evaluate the efficacy and safety of VE202, a novel drug containing live bacterial strains, for the treatment of mild to moderate ulcerative colitis. This randomized, double-blind, placebo-controlled study aims to assess the potential benefits of VE202 in improving endoscopic response and overall patient outcomes.

Table of Contents

What is VE202?

VE202 is an innovative medication being studied for the treatment of mild-to-moderate ulcerative colitis. It is a capsule containing live bacteria, specifically designed to help restore balance to the gut microbiome.[1] The drug is also known by its alternative name, JNJ-72537634.

How VE202 Works

VE202 is a unique combination of live bacterial strains that belong to various clusters of Clostridia and Bacilli. These bacteria are believed to play a crucial role in maintaining a healthy gut environment. By introducing these beneficial bacteria, VE202 aims to restore balance to the gut microbiome, which may help reduce inflammation and improve symptoms of ulcerative colitis.[1]

The drug contains multiple strains of bacteria, including:

  • Clostridia strains from clusters XIVA and IV
  • Bacilli strains from cluster XVIII

These bacterial strains are carefully selected to work together in promoting gut health.

Target Condition: Mild-to-Moderate Ulcerative Colitis

VE202 is being studied for the treatment of mild-to-moderate ulcerative colitis. Ulcerative colitis is a type of inflammatory bowel disease (IBD) that causes inflammation and ulcers in the lining of the large intestine (colon) and rectum. Symptoms can include diarrhea, abdominal pain, and rectal bleeding.[1]

Clinical Trial Details

A Phase 2 clinical trial is currently underway to evaluate the effectiveness and safety of VE202 for patients with mild-to-moderate ulcerative colitis. This trial is a randomized, double-blind, placebo-controlled study, which means that participants are randomly assigned to receive either VE202 or a placebo, and neither the participants nor the researchers know who is receiving which treatment.[1]

The main objectives of the trial are:

  1. To evaluate the efficacy of 8 weeks of treatment with VE202 in terms of endoscopic response at Day 56
  2. To evaluate the safety of VE202 throughout the study

Eligibility Criteria

To participate in the clinical trial, patients must meet certain criteria. Some key eligibility requirements include:[1]

  • Age between 18 and 75 years
  • Diagnosed with ulcerative colitis for at least 3 months
  • Active mild to moderate ulcerative colitis, as determined by specific medical criteria
  • No previous treatment with certain types of medications for ulcerative colitis

There are also several exclusion criteria, such as a history of Crohn’s disease, recent use of antibiotics or probiotics, and certain other medical conditions.

Potential Benefits

If proven effective, VE202 could offer several potential benefits for patients with mild-to-moderate ulcerative colitis:

  • Improvement in symptoms such as diarrhea, abdominal pain, and rectal bleeding
  • Reduction in inflammation of the colon
  • A new treatment option for patients who have not responded well to other therapies
  • Potential for fewer side effects compared to some existing treatments, as it uses naturally occurring bacteria

Safety Considerations

As with any new medication, safety is a primary concern in the clinical trial of VE202. The study is designed to carefully monitor for any adverse effects. Some key safety considerations include:[1]

  • Monitoring for any treatment-related adverse events
  • Assessing the occurrence of serious adverse events
  • Evaluating the long-term safety of using live bacterial strains as a treatment

It’s important to note that VE202 is still in the investigational stage, and its safety and efficacy have not yet been fully established. Patients interested in this treatment should discuss it with their healthcare provider and consider participating in clinical trials if eligible.

Aspect Details
Study Type Phase 2, randomized, double-blind, placebo-controlled clinical trial
Drug Name VE202 (capsule containing multiple live bacterial strains)
Target Condition Mild to moderate ulcerative colitis
Primary Objectives 1. Evaluate efficacy in terms of endoscopic response at Day 56
2. Assess safety of VE202
Treatment Duration 8 weeks
Key Inclusion Criteria – Ages 18-75
– Diagnosed UC for at least 3 months
– Active mild to moderate UC
– No prior biologic treatment for UC
Key Exclusion Criteria – History of Crohn’s disease
– Recent use of antibiotics, probiotics, or certain herbal preparations
– Active infections or other specified medical conditions
Primary Endpoints 1. Endoscopic response rate at Day 56
2. Treatment-related adverse events

FAQ

  • What is VE202 and how does it work? VE202 is a capsule containing multiple strains of live bacteria, primarily from the Clostridia and Bacilli clusters. It is designed to help restore balance to the gut microbiome, which may play a role in reducing inflammation and improving symptoms in ulcerative colitis patients.
  • Who is eligible to participate in 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 have active disease, as defined by specific criteria, and should not have previously received certain types of treatments for UC.
  • How long does the treatment last in this study? The treatment period in this study lasts for 8 weeks, during which participants will receive either VE202 or a placebo.
  • What are the main goals of this clinical trial? The primary objectives are to evaluate the efficacy of VE202 in terms of endoscopic response after 8 weeks of treatment, and to assess the safety of VE202 throughout the study period.
  • Are there any restrictions on medications or treatments during the trial? Yes, there are several restrictions. Participants cannot have received certain biologic agents or other specific treatments for UC. If taking corticosteroids, the dose must be stable and below a certain level. Use of antibiotics, probiotics, and some herbal preparations is also restricted before and during the study.

Ongoing Clinical Trials on Clostridia, Cluster Xiva, Strain Relative Muricomes Sp000509105, 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), typically indicating reduced inflammation and healing.
  • Mayo score: A scoring system used to assess the severity of ulcerative colitis, taking into account factors such as stool frequency, rectal bleeding, and endoscopic findings.
  • Placebo: An inactive substance that looks like the real medicine but has no therapeutic effect, used as a control in clinical trials to test the effectiveness of new treatments.
  • Randomized, double-blind study: A type of clinical trial where participants are randomly assigned to different treatment groups, and neither the participants nor the researchers know who is receiving the actual treatment or placebo.
  • Microbiome: The collection of all microorganisms, including bacteria, viruses, and fungi, that naturally live in and on the human body, particularly in the gut.
  • Colony Forming Unit (CFU): A measure used to estimate the number of viable bacteria or fungal cells in a sample, often used to quantify the amount of probiotics or live bacteria in a product.
  • Flexible sigmoidoscopy: A medical procedure that allows doctors to examine the lower part of the large intestine using a flexible, lighted tube.
  • Corticosteroids: A class of anti-inflammatory medications often used to treat ulcerative colitis flares, but which can have significant side effects with long-term use.
  • Biologic agent: A type of medication made from living organisms or their products, often used to treat autoimmune diseases like ulcerative colitis by targeting specific parts of the immune system.

References

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