Recent Developments in Microbiome Therapeutics Recent-Developments-in-Microbiome-Therapeutics-Nov | Page 11

for treating Clostridium difficile infections to its product portfolio. CP101 is currently undergoing a multicenter, double-blind, placebo-controlled Phase 2 clinical trial 47 . Second Genome 48 is a clinical stage company, currently focusing on developing its lead candidate SGM-1019, for the treatment of Inflammatory Bowel Disease (IBD). SG-1019 is a small molecule inhibitor of a key microbiome-mediated target that addresses pain and inflammation in IBD. It has successfully completed Phase 1 clinical trials. In April 2016, Second Genome received $42.6 million in Series B financing from Roche Venture Fund and Pfizer Venture Investments, raising its total funding to nearly $63 million. A low-profile company in this domain is NuBiyota 49 . In April 2017, Takeda struck a deal 50 to access NuBiyota’s microbiome platform based on a cocktail of bacteria for gastro-intestinal infections. With this strategic collaboration, NuBiyota received an upfront payment of an undisclosed amount and will receive success-based payments based on development, regulatory and commercial milestones, as well as royalties based on net sales. In September 2017, a group of Ghent University researchers published results from an in vitro study 51 on the effects of butyrate-producing bacteria on patients affected by Crohn’s Disease. The study showed that supplementing with butyrate-producing bacteria strengthened the epithelial barrier function and increased butyrate production. The French company, Enterome Bioscience 52 , is one of the bigger players in the domain. The company has a diverse microbiome therapeutics portfolio including Crohn’s Disease, IBD, Immuno-oncology and Autoimmune diseases. The company also develops diagnostic tools for IBD and immuno-oncology. In January 2016, Enterome announced a strategic drug discovery collaboration with Takeda, and a collaborative research agreement with INRA 53 and Janssen Biotech (a Johnson & Johnson company), to develop new therapeutics for IBD and Crohn’s Disease. In October 2017, the company completed Phase 1 clinical trials for its lead candidate, EB8018, a molecule designed to block FimH, a bacterial adhesin, for the treatment of Crohn’s disease. Phase 2 for the drug is expected to start in 2018. EB8018 was in-licensed from Vertex Pharmaceuticals in April 2016. Enterome has raised a total of approx. $34 million via three rounds of funding. 47 https://clinicaltrials.gov/ct2/show/NCT03110133 48  http://www.secondgenome.com/ 49  https://www.nubiyota.com/ 50  https://www.takeda.com/newsroom/newsreleases/2017/takeda-enters-into-strategic-collaboration-with-nubiyota-for- microbiome-therapeutics/ 51 Geirnaert, A. et al (2017), Butyrate-producing bacteria supplemented in vitro to Crohn’s disease patient microbiota increased butyrate production and enhanced intestinal epithelial barrier integrity. Scientific Reports 7, Article Number: 11450. doi: 10.1038/s41598-017-11734-8 52  http://www.enterome.fr/site/ 53 INRA: French National Institute for Agriculture Research 11 Recent Developments in Microbiome Therapeutics