Express reduces the risk of intestinal infection recurrence by more than 80%, and oral microbial therapy reaches the phase 2 clinical primary endpoint

▎The content team editor of WuXi AppTec recently announced that its oral microbial therapy VE303 under development has reached the primary endpoint in a phase 2 clinical trial to prevent recurrence of Clostridium difficile infection (CDI) in high-risk patients
.

The test results show that compared with placebo, VE303 reduces the risk of recurrence in high-risk patients by more than 80%
.

The company plans to start a phase 3 clinical trial of VE303 in 2022
.

 The current treatment for recurrent Clostridium difficile infection is based on antibiotics, but this may make patients prone to recurrence and various other bacterial infections, and promote the spread of antibiotic resistance
.

As a potential new preventive tool, VE303 aims to rebuild the gut microbiome of patients while supporting better antibiotic management in the medical system
.

VE303 is a rationally designed microbial therapy, derived from a purely cloned bacterial cell bank, which can produce powdered standardized preparations, avoiding the inconsistency of human donor fecal materials
.

It includes a flora composed of eight kinds of live bacterial strains with clear characteristics, which can help change the environment of the intestinal flora and prevent pathogens from colonizing the intestine
.

Image source: 123RF The trial enrolled 79 patients.
The results of the trial showed that compared with placebo, the high-dose VE303 group (n=29) reached the primary endpoint of a lower recurrence rate within 8 weeks (13.
8% vs.
45.
5%) ), the absolute risk of disease recurrence was reduced by 31.
7%, and the relative risk of recurrence was reduced by more than 80% (p=0.
0077)
.

In general, VE303 is generally well tolerated as observed in the trial
.

There were few serious adverse events reported in the trial, and they were not related to treatment
.

"Although many antibiotics are approved to treat C.
difficile infections, patients still relapse frequently
.

And this trial shows that a certain combination of bacteria has the potential to prevent recurrent C.
difficile infections
.

" University of Leeds Professor Mark H.
Wilcox said, “Because this therapy provides consistent composition and quality, and does not rely on feces obtained from human donors for production or transportation, VE303 can solve some potential problems, including lack of product consistency.
, Scalability, and infection risks associated with existing methods
.

"Reference: [1] Vedanta Announces Positive Topline Phase 2 Data for VE303 in High-Risk C.
difficile Infection and Exercise of $23.
8 Million Option by BARDA.
Retrieved October 5 , 2021, from https:// Disclaimer: WuXi AppTec content The team focuses on introducing global biomedical health research progress
.

This article is for the purpose of information exchange only.
The opinions expressed in the article do not represent the position of WuXi AppTec, nor does it mean that WuXi AppTec supports or opposes the views in the article
.

This article is not a treatment recommendation either
.

If you need guidance on treatment plans, please go to a regular hospital for treatment
.