COO of Leading BioSciences, Greg Doyle, explains their platform of products to treat and halt multi-organ failure resulting from shock.

Zacks Private Briefly describe what happens to the human body during acute shock and explain the resulting gastrointestinal breakdown.

Greg Doyle Acute shock is the body’s response to dangerously low blood pressure. Blood and oxygen are diverted to the heart, brain and lungs, resulting in less blood flow to the GI tract. Prolonged oxygen deprivation in the gut leads to hypoperfusion of the intestinal mucosal barrier. The digestive enzymes in our bodies used to digest our food are strong enough to degrade almost all biological tissues. Basically, we have a lethal dose of digestive enzymes in our body at all times. Think of this as a controlled volcano under healthy conditions. This barrier protects your body from the lava flow by limiting its reach to the center of the small intestine. In GI breakdown, this lava begins to break down the protective lumen of the small intestine and leak into the body. Think of it like battery acid leaking through—the body begins to digest itself.

ZP Leading BioSciences developed a patent-protected oral formulation. How does LB1148 treat and halt gastrointestinal breakdown?

GD LB1148 inhibits the GI breakdown in the gut and allows the gut to heal itself. The intestinal lining can rejuvenate itself every 5 days. The first 24 hours are critical. Ideally, the treatment would begin within 4-6 hours.

ZP What does LB1148 taste like?

GD It tastes like sugar water. There is one active ingredient—an enzyme blocker. The other ingredients include polyethylene glycol, a carrier of the drug that helps transport the drug all the way to the distal end of the small intestine; and salts, sugars and healing nutrients to support healing of the intestinal lining.

ZP Are there current treatments widely used to treat GI breakdown? Describe your market.

GD There are no current treatments for GI breakdown. Annually, over 633,000 septic shock cases occur in the United States. The next largest groupings of shock include cardiogenic shock/complicated cardiovascular surgery (410,000 patients), and hemorrhagic and/or hypovolemic shock (280,000 cases). Worldwide, these forms of acute shock kill millions of patients every year. In the U.S., acute shock conditions result in over $40B in annual hospital billings to the healthcare system. That’s a large market and a striking need for an available treatment.

ZP The Ebola outbreak in West Africa appears to be stabilized. You have offered LB1148 as a potential supportive therapy for Ebola under the FDA’s ‘compassionate use’ program—explain how this treatment could improve patient outcomes in Ebola.

GD Most Ebola patients don’t die from the virus but from the prolonged period of shock. The severe symptoms of shock usually culminate around day 7—the death zone for Ebola—LB1148 may be used to prevent the resulting GI breakdown and buy the body some time to fight the virus. There are other tropical diseases that LB1148 might be a good therapy for as well.

ZP Besides treatment in Ebola cases, what other uses do you see for LB1148?

GD LB1148 might be used in the condition of sepsis; as a treatment for cardiogenic shock as a result of heart surgery (410,000 cases in the U.S.) or even as a preventative measure before surgery (8.1 million heart surgeries each year in the U.S.). There are applications to treat symptoms of hemorrhagic shock as a result of combat wounds. We hope one day to have it in the flap jacket of every soldier. Other applications are for shock and multi-organ failure in patients with severe burns or for shock in patients undergoing radiation treatments.

ZP Does the mechanism have broader applications beyond acute shock? What about long-term chronic conditions?

GD Shock and multi-organ failure is the acute manifestation of the mechanism. There are lower level GI leaks that occur, for example in diabetics or in patients who have had only minor surgery. These low level leaks are not enough to kill you but the diminished function contributes to the cleavage of many receptors of common cells (i.e. the insulin receptor in Type II diabetes and the LDL receptor in high cholesterol), among many others. The market for the acute and chronic manifestations of the GI breakdown we refer to as “autodigestion” is extremely large. Our pipeline includes many applications for this overall mechanism of action.

ZP What other products are in the company’s pipeline?

GD We also have completed very promising pre-clinical research for a hand-held, breath diagnostic device to detect when a patient is starting to experience the GI breakdown mechanism and entering into the early stages of shock and multi-organ failure. We have also completed successful pre-clinical research on a peritoneal lavage treatment, which would add specific protease inhibitors into the current surgical lavage cocktail. Currently, existing lavages during surgery includes saline and antibiotics; LB1148 added to the lavage may also protect the vital organs from digestive enzymes that may have entered the bloodstream.

ZP Currently, LB1148 has received clearance from the FDA for a U.S. phase two clinical trial—what do you hope to discover during this trial and what hurdle does it remove for marketing and use of the treatment if this trial proves successful?

GD These two trials are gold standard, randomized, blinded, placebo-controlled and are designed to prove the efficacy of the drug. The next 18 months of these two trials will determine whether we have a major blockbuster product. We envision an acquisition target in the range of 750 million-1.5 billion dollars. While we do plan to sell LB1148 to a pharmaceutical company after successful completion of the upcoming trials (Q4 2016), Leading BioSciences is a platform investment with many other exciting and promising products and therapies in its pipeline, all based on the same GI breakdown mechanism of action. We anticipate taking the company public for the remaining products within our platform.