InflammaGen, LLC, in collaboration with the Bioengineering Department at UC San Diego, was formed to commercialize a new treatment for critically ill patients with multiple organ dysfunction syndrome (MODS), formally known as multiple organ failure. MODS is caused by acute shock (trauma, sepsis, burns, SIRS, etc.) and has a high mortality rate with very few treatment options. This is a significant, unmet medical need as septic shock alone results in 735,000 hospitalizations yearly and 215,000 deaths in the U.S., the second leading cause of in-hospital death in the U.S.
This new treatment, Shok-Pak, is a significant paradigm shift in thought process and in the way critically ill patients or patients needing ICU level care are treated. InflammaGen’s main medication has been approved by the FDA for years but is administered via a different route, directly into the stomach and intestine, blocking potent digestive enzymes.
Dr. Geert Schmid-Schönbein and colleagues discovered a previously unknown pathway that leads to a severe form of inflammation and organ dysfunction in shock. They demonstrated in in vitro and animal studies that the digestive enzymes in the lumen of the intestine are involved in inflammation and multi-organ failure. In healthy patients, digestive enzymes are usually restricted to the lumen of the intestine by the epithelial cell barrier and they do not enter the wall of the intestine. But under conditions of shock, the epithelial cell barrier becomes permeable and the highly active and potent digestive enzymes are carried into the wall of the intestine where they start to break down the intestinal wall. These enzymes and the breakdown products they generate are then carried into the bloodstream and lymphatic system where they can lead to multi-organ failure and death. As the body appears to be digesting itself, this research has been coined, “Autodigestion”.
The researchers discovered that they could inhibit the progression from acute shock to MODS by delivering an enzyme inhibitor directly into the lumen of the intestine, via a nasogastric (NG) tube, thereby blocking the digestive enzymes. This blockade leads to a dramatic reduction of inflammation and death in diverse forms of shock (hemorrhagic shock, septic shock, peritonitis shock, shock due to intestinal ischemia) with a highly significant increase in short- and long-term (weeks and months) survival. For this discovery, Dr. Geert Schmid-Schönbein was recognized by his peers and honored with the 2008 Landis Award from the Microcirculatory Society.
Animal and Human Testing
Animal testing, conducted at two university medical centers, is complete in two different animal species. Results are remarkable and statistically significant with an almost identical reduction of MODS and improved recovery.
Several patients have been treated outside the U.S. as a rescue therapy in two hospitals. These outcomes match closely to the preclinical results, confirming the efficacy and potential of this new Shok-Pak therapy. Moreover, a 200 patient Phase II pilot clinical trial is currently enrolling patients at the VA San Diego Medical Center.
The preclinical work for InflammaGen has been funded by the National Institutes of Health. The translational work has been funded by Leading BioSciences Inc. (formerly Leading Ventures). InflammaGen is looking to raise $5 million to complete Phase II trials and find a partner to commercialize and bring to market.
MODS is caused by acute shock (trauma, sepsis, burns, SIRS-systemic inflammatory response syndrome, etc.) and has a high mortality rate with very few treatment options. This may be the most significant, unmet medical need in the United States with 735,000 incidents yearly and is the second leading cause of in-hospital death in the US with a high fatality rate of 30%.
InflammaGen Therapeutics, Inc.
A Leading BioSciences, Inc. Company
3580 Carmel Mountain Road Suite 300, San Diego, CA 92130
Tel: (949) 939-6005
John Rodenrys – CEO
Hank Loy – President
Greg Doyle – CFO
PhD Professor, Bioengineering
Jacobs School of Engineering