Seres Therapeutics Announces Publication of SER-155 Phase 1b Results in Nature Medicine Showing Reduced Bloodstream Infections in Allogeneic Hematopoietic Cell Transplantation Recipients
Key Highlights
- ➤SER-155 cut bloodstream infections 77% versus placebo in Phase 1b allo-HCT study
- ➤Systemic antibiotic exposure averaged 9.2 days versus 21.1 days with placebo
- ➤SER-155 is Phase 2-ready in allo-HCT, pending receipt of funding
- ➤SER-155 received FDA Breakthrough Therapy and Fast Track designations
- ➤SER-155 produced 80% immunosuppressive-free clinical response in 15-patient irEC study
Expert Statements
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“Publication in Nature Medicine is an important milestone for the SER-155 program and recognition of the innovative science being advanced by Seres”
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“Many bloodstream infections in transplant patients originate in the gut, when pathogens expand and cross a damaged intestinal barrier.”
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“SER-155 was designed to address both sides of that problem by preventing the colonization and expansion of pathogens, many that can harbor antibiotic resistance, in the gastrointestinal (GI) tract that results from extensive antibiotic use in these patients and also protecting and improving mucosal epithelial barrier integrity that is disrupted by conditioning cancer therapy to limit bacterial translocation from the GI into the bloodstream and potential mortality due to infection.”
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“In this study, SER-155 reduced bloodstream infections while improving biomarkers of barrier integrity and systemic inflammation, providing clinical validation of these mechanisms.”
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“We believe our live biotherapeutic approach could be highly differentiated in multiple diseases where loss of gut mucosal epithelial barrier integrity is thought to play a central role.”
Matthew Henn, President and Chief Scientific Officer of Seres Therapeutics
“In addition, SER-155 has the potential to address the continued emergence of antimicrobial resistant infections, particularly those in immunocompromised patients, and we thank CARB-X for their prior support of this program, our collaborators and the patients who participated in this clinical study.”
Richard Kender, Executive Chairman and Interim Chief Executive Officer of Seres Therapeutics
“These results, now peer-reviewed and published in Nature Medicine, reinforce our belief in the potential of SER-155 to prevent bloodstream infections in immunocompromised patients like allo-HCT patients.”
Richard Kender, Executive Chairman and Interim Chief Executive Officer of Seres Therapeutics
“We believe the ability of SER-155 to strengthen the gut barrier and reduce inflammation gives it potential well beyond transplant, including in immune checkpoint inhibitor-related enterocolitis (irEC), a serious complication of cancer immunotherapy where an immunosuppressive-free treatment could allow patients to stay on their cancer therapy.”
Peer-reviewed publication reports a 77% relative risk reduction in bloodstream infections and significantly lower systemic antibiotic exposure with SER-155 compared with placebo
Translational data from the study support the SER-155 mechanisms of strengthening the mucosal epithelial barrier and reducing systemic inflammation
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