On August 10, Finch Therapeutics announced that FIN-524, its microbiome-targeting drug candidate for the treatment of ulcerative colitis (UC ), will be taken on and advanced into clinical development by Takeda Pharmaceutical Co Ltd under the new name TAK-524. TAK-524 is an oral formulation consisting of both spore-forming and non-spore-forming bacterial strains. It is anticipated to enter Phase I clinical trials in H1 2022. This move demonstrates Takeda ’s commitment to pursuing novel microbiome-targeting therapeutic approaches in the treatment of gastrointestinal diseases and cements its role as the leading Big Pharma player within this growing field.

Takeda is currently developing multiple microbiome-targeting agents through a number of collaborations with innovative small companies and one of the first relationships that the company entered into was with Finch Therapeutics. In April 2017, Takeda and Finch Therapeutics entered a global collaboration agreement for the joint development of TAK-524 for UC. TAK-524 was Finch’s first Rationally Selected Microbiota (RSM) therapy, meaning a treatment comprised of select bacteria that demonstrated promising results in fecal microbiota transplantation human studies. The partnership between Takeda and Finch developed further after November 2019, when Finch granted Takeda access to its proprietary discovery platform for targeting Crohn’s disease (CD) and then began collaborating on the CD-targeting microbiome-targeting candidate, FIN-525, which is currently in preclinical development.

Finch is not the only company that Takeda has formed a relationship with for the development of microbiome-targeting therapies. Takeda’s current pipeline includes three microbiome-targeting therapeutics in clinical development. Sibofimloc (TAK-018) is in Phase II development (NCT03943446) in partnership with Enterome Bioscience for the treatment of CD. MET-2 and TAK-039 are in Phase I development for UC and Clostridioides difficile infection, respectively, in partnered development with Nubiyota . Aside from TAK-524 and FIN-525, Takeda also has a candidate in the preclinical stages of development: Debio-1454M, a novel microbiome-targeting agent licensed from Debiopharm Group in 2020.

Among the microbiome-targeting agents currently in the pipeline, the vast majority are being developed by small and mid-size biotech companies. GlobalData believes that similar to what has been seen with Takeda, the field will continue to see a trend of Big Pharma players getting involved in this space through strategic partnerships and licensing agreements. Thus far, the only other major Big Pharma player in the microbiome space is Johnson & Johnson, with its own JNJ-72537634 in Phase I trials (NCT03931447) for UC and a stake in Vedanta Biosciences’ VE-202, which is also in Phase I trials for UC (NCT03723746). AbbVie has several pipeline agents in the discovery stages for UC and irritable bowel syndrome, but nothing yet in clinical development.

Microbiome-targeting therapeutics have become an important priority for Takeda, as highlighted by the company’s decision to take on early clinical studies of TAK-524. With three drugs at a preclinical level and another three candidates in Phases I and II of clinical development, Takeda clearly perceives the potential within this growing space. By forming partnerships with important microbiome-specialized companies, the company appears to be leading the way among Big Pharma players in microbiome-targeting treatments.