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SEC Filings

8-K
SERES THERAPEUTICS, INC. filed this Form 8-K on 11/08/2018
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New data supporting SER-109 activity presented at ID Week 2018 conference: SER-109 data from the completed Phase 2 study provided insights into the potential mechanism of action of microbiome therapeutics for C. difficile infection. Presented results showed that SER-109 administration led to changes in the metabolic products created by the microbiome, including higher concentrations of secondary bile acids thought to be inhibitory to C. difficile growth.

 

   

SER-287 development activity: The Company has made operational progress towards initiating a SER-287 Phase 2b clinical study in patients with active mild-to-moderate ulcerative colitis (UC). To expedite the time and resources required to obtain top-line results from this study, the Company has modified the previously planned four-arm placebo-controlled study design into a smaller, three-arm study in approximately 200 patients that will include two different doses of SER-287, both following pretreatment with oral vancomycin, and a placebo arm. Seres has designed this study as a potentially pivotal trial, and the Company is awaiting feedback from the FDA on this final study design.

Based on modification to the Nestlé Health Science collaboration agreement, Seres now expects to receive $40 million in milestone payments from Nestlé Health Science following initiation of the SER-287 Phase 2b study. Because the SER-287 Phase 2b study could serve as a pivotal trial, the parties agreed that at initiation of the SER-287 Phase 2b study Seres would receive $40 million in contractual payments corresponding to both the Phase 2 milestone and a payment of the Phase 3 milestone.

 

   

SER-401 immuno-oncology development activity: In collaboration with the Parker Institute for Cancer Immunotherapy and MD Anderson Cancer Center, Seres is continuing activities to prepare the evaluation of the potential for SER-401 to augment checkpoint inhibitor response in patients with metastatic melanoma.

 

   

New Chief Medical Officer: Seres appointed Kevin Horgan, M.D., as Executive Vice President and Chief Medical Officer. Dr. Horgan will lead Seres’ clinical development, clinical operations, regulatory affairs, and medical affairs functions, and report directly to Dr. Pomerantz. He succeeds Seres’ outgoing Chief Medical Officer, Michele Trucksis, Ph.D., M.D., who will continue to provide clinical consulting services to the Company. Over a three-decade academic and industry career, Dr. Horgan has contributed to the development and approval of multiple therapeutics across immunology and oncology indications. Most recently, Dr. Horgan was Vice President of Clinical Development at AstraZeneca where he led the development of combination immuno-oncology programs. Dr. Horgan earned his medical degree from University College Cork in Ireland and did his medical residency at The Johns Hopkins Hospital in Baltimore, Maryland.


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