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8-K
SERES THERAPEUTICS, INC. filed this Form 8-K on 08/02/2018
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system and were correlated with clinical outcome in the SER-287 Phase 1b study. Recent transcriptomic data from mucosal biopsies taken before and after SER-287 administration provides additional clinical evidence linking SER-287 administration to the modulation of host pathways, including innate immune signaling, epithelial barrier integrity, antibacterial defenses, and short chain fatty acid metabolism. Seres remains the only company with human clinical microbiome data sets, which are critical in determining mechanism of action, and the rational design of follow-on drugs. Seres also provided an overview of the published clinical data from its collaborators at MD Anderson Cancer Center and its own pre-clinical data supporting the potential for microbiome therapeutics to augment checkpoint inhibitor drugs in the PD-(L)1 pathway. The R&D day presentation is available on the Investor & Media section of Seres’ website and is expected to be archived for at least the next 21 days.

 

   

SER-287 late stage development activity: The Company expects to initiate the planned SER-287 Phase 2b clinical study in patients with active mild-to-moderate ulcerative colitis (UC) in the coming months. The SER-287 Phase 1b placebo-controlled induction study of 58 patients with mild-to-moderate active UC who were failing current therapies demonstrated that SER-287 administration resulted in a dose-dependent improvement of both clinical remission rates and endoscopic scores. The SER-287 safety and tolerability profile was favorable, with no imbalance in adverse events in patients treated with SER-287, as compared to placebo. Analyses of study microbiome data demonstrated that SER-287 induced dose-dependent engraftment of SER-287-derived bacterial species and identified specific bacterial signatures linked to remission. SER-287 has been granted Orphan Drug Designation by the Food & Drug Administration (FDA) for the treatment of UC in pediatric patients.

 

   

Digestive Disease Week 2018 conference attendance: Seres presented various data sets and held a scientific symposium highlighting SER-287 clinical and microbiome results as well as the promise of microbiome therapeutics for UC, and other forms of inflammatory bowel disease.

 

   

Continued execution of the SER-109 ECOSPOR III Phase 3 study: Seres continues to enroll its SER-109 Phase 3 clinical study in patients with multiply-recurrent C. difficile infection, at sites in both the U.S. and Canada. Several factors have impacted enrollment including primary use of C. difficile toxin testing to increase the accuracy of proper patient inclusion, the widespread availability of unapproved and unregulated fecal microbiota transplantation, and the fact that multiply recurrent C. difficile infection is an orphan disease. It remains premature to provide an estimate for the timing of study enrollment completion. The Company has made various operational changes to further expedite study execution. ECOSPOR III has been designated a Phase 3 trial and the Company expects that this single pivotal study could support SER-109 registration and approval. SER-109 has been designated by the FDA as a Breakthrough Therapy and has also been given Orphan Drug Designation.

 

   

Preparations for SER-401 immuno-oncology clinical study: In collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, Seres is preparing to initiate a clinical study later this year to evaluate the potential for SER-401, a microbiome therapy, to augment checkpoint inhibitor response in patients with metastatic melanoma. We expect this to be the first microbiome drug study in the Immuno-oncology therapeutic area.

 


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