Microbiotal reverse-engineering: How Finch is moving from fecal microbiota transplant to oral therapy

"Finch Therapeutics Inc. is developing an oral alternative to fecal microbial transplant that it believes entails less biology risk than more advanced oral candidates, with more targeted delivery than full microbiome transplants delivered via enema.

Lead candidate FIN-403 is slated to enter Phase II testing this year to treat recurrent Clostridium difficile infection. According to co-founder and CEO Mark Smith, the therapy delivers nearly all of the microbial communities present in donor microbiomes that have successfully prevented recurrence of infection in the clinic.

The company identifies successful donors via a strategic relationship with OpenBiome, a non-profit stool sample biobank and fecal microbiota transplant (FMT) provider that Smith founded in 2012. Finch sponsors the non-profit’s clinical trials in exchange for access to the data.

“We take a top-down approach, starting with something that works,”
Smith told BioCentury. “Other approaches are more bottom-up, where
they say we think we understand the biology, and we’re going after
this mechanism.”

FIN-403 also uses a dual-release oral delivery technology licensed
from Intract Pharma Ltd. that is triggered by both pH and colonic
enzymes for targeted release in the colon. The idea is to deliver an
entire community of microbes with proven efficacy directly to the site
of infection.

In a Phase I dose-finding trial of FIN-403 in 30 C. difficile
patients, Smith said 89% of patients did not experience a recurrence,
similar to the historical 85-90% cure rate of fecal transplants.

The full-community content of FIN-403 differentiates it from a more
advanced oral candidate in development by Seres Therapeutics Inc.
SER-109 contains a cocktail of about 50 species of Firmicute
eubacterial selected from healthy donor microbiomes."

See the full article here