Vedanta makes Clostridioides difficile look easy

Microbiome-targeting agents seem to have a decent shot at treating C difficile infections, if they are rather less certain in other settings. Vedanta said today that its pill VE303, a combination of eight strains of live bacteria grown in cell banks, achieved a 31.7 percentage point risk reduction versus placebo in the rate of infection recurrence. The data refer to only the higher dose administered in the phase 2 Consortium trial; on the lower dose Vedanta is silent. Still, the data were good enough to spur Barda to hand over $23.8m to support phase 3 studies, under a contract it has had with Vedanta since last year. These trials ought to begin next year, putting Vedanta some way behind Seres and Ferring. The former hopes to file its C diff project SER-109 for US approval next year, and Ferring should get its pivotal data in the same time frame. Elsewhere, Kaleido Biosciences reported topline biomarker data from a tiny trial of its microbiome asset KB295 in mild-to-moderate ulcerative colitis. A phase 2 trial is slated for 2022, and the group will hope to avoid the dismal fate of Seres in this disease

Data from the Consortium trial of Vedanta's VE303
  High-dose VE303 Placebo
Recurrence rate within 8wk 13.8% 45.5%
Reduction vs placebo in the odds of a recurrence 81%, p=0.0077
Source: company release.

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