A novel, non-antibiotic, microbiome-directed agent to prevent post-surgical infection

SUMMARY Covira Surgical, Inc. is developing CS-0003, a first-in-class, orally administered non-antibiotic therapy for preventing infections in patients undergoing gastrointestinal (GI) surgeries. Despite improved surgical procedures, broad use of antibiotics, mandated asepsis measures, and enhanced recovery programs, post-surgical infections remain a clear and present danger to patients. Surgical site infections (SSIs) are a major cause of morbidity, prolonged hospitalization, increased healthcare expenditures, and mortality for the approximately four million Americans who undergo inpatient GI surgery annually. While SSIs can result from direct intraoperative contamination of the surgical site, emerging evidence suggests that many, if not most SSIs (wound infections, organ space infections, anastomotic leaks) may originate from the patient’s own microbiota. Common pathogens causing such complications (i.e., Enterococcus faecalis, Pseudomonas aeruginosa) may be present in the gut before surgery. It is estimated that 50% or more of the pathogens causing SSIs are now resistant to antibiotics chosen for prophylaxis. CS-0003 prevents SSI by maintaining the health-promoting effects of the native gut microbiota while suppressing the virulence of the proliferating pathobiota. CS-0003 directly suppresses bacterial virulence without affecting bacterial growth: it provides microbes with a readily available source of phosphate while providing a physical shield against bacteria from adhering to and invading the epithelial surface. CS-0003 is intended for use immediately before and after surgery. Rodent studies show that CS-0003 prevents SSI against multiple human pathogens and across various surgical models relevant to the human condition. The overall objective of this Fast-Track STTR is to advance the preclinical and clinical development of CS-0003 as an adjunctive measure to prevent SSIs. In Phase I, we will demonstrate CS-0003 efficacy in a large animal model. In Phase II, we will develop methods for large-scale CS-0003 production and then perform comprehensive preclinical testing. Successful completion of the project will provide the data required for IND submission.