A Gut Check for Post-Op Infection: Covira Offers a Pro-Bacteria Approach
Alverdy, who is Covira’s founder and chief scientific officer, is a globally recognized expert in post-surgical infection research including surgical site infections (i.e. anastomotic leak) and post-surgical sepsis. His research focuses on uncovering the molecular details of surgical infections and includes more than 250 publications backed by over $10 million in NIH funding.
The question Alverdy has spent his career working to answer is why, despite the multiple advances in infection control measures, do patients still experience life-threatening postoperative infections. This has led him to examine the biological processes that occur when someone undergoes major surgical stress – and to make a crucial discovery important to the field.
During surgical stress, a key nutrient (phosphate) is depleted in the gut microbiome triggering otherwise innocuous bacteria to become harmful in what Alverdy describes as a “Dr. Jekyll to Mr. Hyde” scenario. These bacteria can then travel to the operation site where they cause local infection.
“Despite emerging evidence to the contrary, most experts in the field continue to believe that postoperative infections are due to some type of breach in sterile technique where a bacterial pathogen somehow contaminates an otherwise sterile operative field,” said Alverdy. However, as work from his lab demonstrates, most bacteria that cause a surgical site infection arise from within the gut microbiome.
As a solution, the researchers proposed to flood the gut with a durable form of consumable but non-absorbable phosphate that would feed bacteria and prevent them from becoming harmful.
“We are preventing bacteria from escaping the gut microbiome by disincentivizing their exit with phosphate and physically shielding their escape so they cannot travel to the operative site and cause an infection,” said Covira CEO Peter Farmakis. “Covira is taking a novel biological approach, an inside-out approach to help patients prepare for and prevent surgical site infections.”
Initial work with this idea involved multiple efforts by faculty across the basic sciences and physical sciences at the University of Chicago, including Matt Tirrell, Dean of the Pritzker School of Molecular Engineering, Covira advisory board member, and pioneering researcher in the fields of biomolecular engineering and nanotechnology. These interactions resulted in the development of CS-0003, a proprietary patented compound that inhibits bacterial virulence without altering bacteria growth and viability.
“Antibiotics function as a kill strategy against bacteria, which is a reactive approach to infection and not sustainable,” Farmakis added. “We’re the only ones that we know of right now that are taking a proactive, biologically sustainable, evolutionary stable approach to modulating the gut microbiome.”
According to the company – which anticipates seeking additional funding in 2023 for its lead asset – CS-0003 enhances the healing power of the gut microbiome by embedding the local environment with a durable form of phosphate. The proprietary solution is a prescription medication that is mixed with water and taken 3 days prior to surgery and 3 days after surgery. CS-0003 coats the gastrointestinal tract with a mucus-like shield that enhances its barrier function and delivers phosphate directly to the gut microbiome, which stops bacteria migration and prevents post-surgical infections.
Moving forward with commercialization Covira is working to scale CS-0003 and signed an agreement with Toxicology Research Laboratory to complete IND-enabling studies and Ground Zero Pharmaceuticals for regulatory consulting, as it looks to file an investigational new drug (IND) application to prevent post-operative infections. Additionally, Covira recently announced the appointment of industry veteran Brian Yoor as Chairman of the Board of Directors. “We’ve done several things to set us up for success,” said Farmakis.