UPDATE! April 5th, 2017 Finch Therapeutics begins collaboration with Takeda Pharmaceuticals and gets $10 million.
http://www.fiercebiotech.com/biotech/finch-therapeutics-takeda-ink-new-microbiome-gi-collab
April 2nd, 2017
Finch Therapeutics is a relatively new microbiome therapeutics company that is located in Somerville, MA. Their focus is on developing “Microbiotics”, a class of microbial therapies consisting of either a broad spectrum of healthy gut microbes in capsule form in FIN-403 drug product, or a designed community of microbes, a “synthetic ecology”, also in capsule form in their FIN-524 drug product. For reference, FIN-403 is a therapy directed towards recurrent Clostridium difficile infections, and FIN-524 is directed towards treating ulcerative colitis.
While neither of these ideas is new in the microbiome space of drug development, their approach to deciding components of these synthetic and beneficial ecologies is interesting. They use a “human-first” platform based on clinical data, which is the data collected during and after humans are treated with a therapy; in this case it’s most likely data of what microbes are in patient stool during and after therapy. Basically this clinical patient data from thousands of fecal matter transplants (FMTs) is fed into a machine-learning algorithm by Finch's data scientists. The output of this algorithm seems to be the microbial groups (I’m assuming at the genus or maybe species level) that were associated with positive results in clinical trials. These microbial strains are then grown up in Finch’s lab and combined into a Microbiotic drug. The human-first approach is practical because using mice as models for human gut diseases does not always translate well from lab to practice; animal model data isn’t always relevant until tested in humans.
Another interesting component of their drugs is the capsule which carries the drug product, it combines Aquashell(™) with Phloral (developed by Intract Pharma, London, UK). Aquashell is a controlled release system developed by Finch Therapeutics, and Phloral is a targeted release system which uses pH and the presence of certain microbes to release the contents of the capsule directly into the colon. The colon is where both Clostridium difficile and ulcerative colitis cause inflammation and other crippling symptoms specific to these diseases.
While details about manufacturing of these drugs at Finch and FDA approvals are not yet available, Finch Therapeutics is a for-profit offshoot of and collaborating with OpenBiome, the non-profit stool bank. This certainly makes it a strong competitor in the development of microbiome-based therapies. OpenBiome has prepared stool-derived preparations for around 20,000 FMTs nationwide since 2013, most of them for the treatment of recurrent Clostridium difficile infections under the FDA’s “Compassionate Use” policy. Finch Therapeutics will use OpenBiome’s biomanufacturing technology, as well as most likely their own manufacturing upgrades and capsule technology, to deliver these drugs in pill form, if they are able to gain approval from the FDA. Phase II trials of their Clostridium difficile drug, FIN-403, plans to begin enrolling patients in mid-late 2017. Results for these trials will most likely turn up in mid-2018.
References:
http://finchtherapeutics.com/
http://www.openbiome.org/press-releases/licensure
https://www.intractpharma.com/phloral
https://inventively.com/search/trademarks/87102953
http://www.fiercebiotech.com/biotech/finch-therapeutics-takeda-ink-new-microbiome-gi-collab
April 2nd, 2017
Finch Therapeutics is a relatively new microbiome therapeutics company that is located in Somerville, MA. Their focus is on developing “Microbiotics”, a class of microbial therapies consisting of either a broad spectrum of healthy gut microbes in capsule form in FIN-403 drug product, or a designed community of microbes, a “synthetic ecology”, also in capsule form in their FIN-524 drug product. For reference, FIN-403 is a therapy directed towards recurrent Clostridium difficile infections, and FIN-524 is directed towards treating ulcerative colitis.
While neither of these ideas is new in the microbiome space of drug development, their approach to deciding components of these synthetic and beneficial ecologies is interesting. They use a “human-first” platform based on clinical data, which is the data collected during and after humans are treated with a therapy; in this case it’s most likely data of what microbes are in patient stool during and after therapy. Basically this clinical patient data from thousands of fecal matter transplants (FMTs) is fed into a machine-learning algorithm by Finch's data scientists. The output of this algorithm seems to be the microbial groups (I’m assuming at the genus or maybe species level) that were associated with positive results in clinical trials. These microbial strains are then grown up in Finch’s lab and combined into a Microbiotic drug. The human-first approach is practical because using mice as models for human gut diseases does not always translate well from lab to practice; animal model data isn’t always relevant until tested in humans.
Another interesting component of their drugs is the capsule which carries the drug product, it combines Aquashell(™) with Phloral (developed by Intract Pharma, London, UK). Aquashell is a controlled release system developed by Finch Therapeutics, and Phloral is a targeted release system which uses pH and the presence of certain microbes to release the contents of the capsule directly into the colon. The colon is where both Clostridium difficile and ulcerative colitis cause inflammation and other crippling symptoms specific to these diseases.
While details about manufacturing of these drugs at Finch and FDA approvals are not yet available, Finch Therapeutics is a for-profit offshoot of and collaborating with OpenBiome, the non-profit stool bank. This certainly makes it a strong competitor in the development of microbiome-based therapies. OpenBiome has prepared stool-derived preparations for around 20,000 FMTs nationwide since 2013, most of them for the treatment of recurrent Clostridium difficile infections under the FDA’s “Compassionate Use” policy. Finch Therapeutics will use OpenBiome’s biomanufacturing technology, as well as most likely their own manufacturing upgrades and capsule technology, to deliver these drugs in pill form, if they are able to gain approval from the FDA. Phase II trials of their Clostridium difficile drug, FIN-403, plans to begin enrolling patients in mid-late 2017. Results for these trials will most likely turn up in mid-2018.
References:
http://finchtherapeutics.com/
http://www.openbiome.org/press-releases/licensure
https://www.intractpharma.com/phloral
https://inventively.com/search/trademarks/87102953