After completing some promising pre-clinical studies, San Diego’s InflammaGen Therapeutics says it is raising additional capital, as it moves to mid-stage trials of an experimental treatment that’s intended to prevent multi-organ failure in patients suffering acute shock.
InflammaGen has “almost closed” on a $2.5 million round of Series A financing, according to CEO John Rodenrys. The seed-stage startup also signed a partnership recently with ChinaBio, a firm based in San Diego, Shanghai, and Palo Alto, CA, that provides consulting, banking, and other services for life sciences companies interested in doing business in China. The life sciences startup also is in discussions with two pharmaceutical companies that are interested in helping InflammaGen commercialize its technology, Rodenrys says. He declined to identify the companies, saying both discussions are covered by non-disclosure agreements.
As I reported last year, InflammaGen has been developing technology conceived by Geert Schmid-Schönbein, a professor of bioengineering at UC San Diego. Schmid-Schönbein suggests that powerful digestive enzymes secreted in the small intestine by the pancreas are largely responsible for “the inflammatory cascade” of life-threatening events that can occur in cases of acute shock. These events typically build up over time, and often lead to multi-organ failure and death.
Shock typically occurs in cases of traumatic injury, including burns, chemical exposure, extreme cold, and infections—and one hallmark is a dramatic drop in blood pressure.
Schmid-Schönbein has shown that when blood pressure plummets in laboratory rats, the epithelial cell barrier lining the inside of the small intestine becomes permeable—allowing digestive enzymes to pass through the intestinal wall. Once through, the enzymes are carried into the bloodstream and lymphatic system, where they do what they are designed to—and begin “digesting” the interior walls of capillaries that supply blood to other organs. The UCSD professor says this is a previously unknown mechanism in acute shock cases. He calls it “autodigestion.”
Schmid-Schönbein says a solution containing enzyme inhibitors could be delivered directly into a patient’s stomach, using a nasal tube. By binding with the digestive enzymes, the inhibitors would prevent the enzymes from going on their rampage.
InflammaGen’s Rodenrys says the company’s experimental, “Shok-Pak” treatment has been used outside the United States to treat 17 patients in two hospitals as a rescue therapy. “We’ve had 14 survivors, which is more than you’d expect,” he says.
In a statement today, InflammaGen says the principal investigator overseeing the mid-stage trial is Erik Kistler, an assistant clinical professor of anesthesiology and critical care at the UC San Diego School of Medicine and the VA Healthcare System in San Diego. In the company’s release, Kistler says, “Patients in shock who survive their initial insult don’t necessarily survive long-term. In addition, morbidity is very high in those patients that do survive. Our animal studies suggest that InflammaGen Shok-Pak could improve functional outcomes and reduce the time patients remain in intensive care, as well as increase long-term survival rates.”
InflammaGen president Hank Loy says the company also has developed a handheld diagnostic breathalyzer that can help emergency room and critical care doctors determine whether a patient is going into shock. (Schmid-Schönbein’s lab has identified a volatile compound that is detected in the breathing of patients with acute shock, but not in control patients.)
Rodenrys and Loy are angel investors who said they’ve been involved with the research and development in Schmid-Schönbein’s lab for many years through Leading Ventures, a firm they had formed as an alternative funding source for early-stage life sciences startups. They renamed the firm Leading Biosciences about six months ago, Rodenrys says, because “we always had to explain that we’re not a venture capital firm.”
Their business model has not changed, however.
“We go to university and federal laboratories and look for technologies we can license, and then work closely to help develop the technology,” Rodenrys says. “We invest directly in the research and development, and it’s typically very early stage. What we typically do is fund the trials needed to get to stage one or two.”
With InflammaGen moving to mid-stage trials, Rodenrys says their focus now is shifting to identify a pharmaceutical partner that can get the technology to late-stage clinical trials “and get it on the market.”