Recent Developments in Microbiome Therapeutics Recent-Developments-in-Microbiome-Therapeutics-Nov | Page 14

Conclusion
The past few years have been abuzz with activity in the Microbiome Therapeutics domain. The amount of research
being conducted in the domain is increasing steadily 63 . Several companies have completed preclinical studies for
their lead candidates and the
stage is set for human trials.
The first drugs targeting the
gut
microbiome
could
hit
the market as early as 2020.
However, failures such as the
one faced by Seres in 2016 with
the Phase 2 trial of SER-109,
as well as regulatory hurdles
could delay the launch of
commercial drugs in the space.
The US FDA and European
Medicines Agency have very
little experience in evaluating
live bacteria as therapeutics causing another level of regulatory challenge. Also, not all big pharma giants are
joining the microbiome therapeutics bandwagon, making it more of a wait and watch game.
63 Data based on search conducted on the PubMed database.
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Recent Developments in Microbiome Therapeutics