VE202 (Regulatory T-lymphocyte modulators) – Vedanta Biosciences

• Vedanta Biosciences presented new pharmacokinetics data from Phase 1 clinical study of VE202, used in the treatment of inflammatory bowel disease (IBD) in healthy volunteers at UEG week 2020
• The data focuses on the kinetics and durability of colonization from an 11-strain consortium of VE202 under various dosing and pre-treatment regimens
• Trial details:
  • Phase 1; Healthy volunteers; N= 74; VE202, or placebo; Primary endpoints: Treatment emergent adverse events, serious adverse events; PCD: Dec’ 19; Completed; Location: Europe
  • The study was double-blind, placebo-controlled for 14 days
  • Regimen:
    

    Cohort	Dosing
    Cohort 1 and 2 – Single day dosing	Oral dosing of a low or high CFU dose of VE202
    Cohort 3 and 5 – Multi day dosing	Oral dosing of a low or high CFU dose of VE202
    Cohort 4 and 6 – Multi day dosing	Pretreated with vancomycin (125mg, qid) for five days followed by one-day washout prior to oral dosing of a low or high CFU dose of VE202

• Results:
  • Colonization kinetics of single day dosing without vancomycin pre-treatment did not result in increased detection of VE202 strains
  • In multiple day dosing cohorts, vancomycin pre-treatment reduced gut microbial density and was required for sustained detection of VE202 compared to non-vancomycin pre-treated cohorts
  • In cohorts 4 and 6, VE202 rapidly increased in detection within 2 days of dosing and peaked at day 7 and day 8 (Tmax) with a mean relative abundance of 18.84% and 24.32% respectively
  • In these cohorts, VE202 strains were detected up to 6 months post-treatment with mean 7.6 and 8.9 total strains and RA 0.83% and 1.00%, respectively
  • VE202 strains were also detected in vancomycin pre-treated placebo cohorts (2.2 and 3.2 mean total strains and RA of 0.25% and 1.56%, respectively, 6 months post-treatment)