Leading BioSciences, Inc. (“LBS”) is a development-stage pharmaceutical company focusing on “autodigestion”. Autodigestion is the foundation of the company’s science and a newly discovered mechanism of disease in which the mucosal barrier and lining of the intestine break-down across a variety of disease states. This leads to the escape of digestive enzymes outside the digestive tract, where the body begins to “eat itself” as digestive enzymes enter into the blood circulation.
The company’s lead product, LB1148, is a proprietary formulation of an oral small molecule therapeutic with a known safety profile that in the proprietary formulation can treat multi-organ failure brought on by shock, in critical care settings. Shock is a life-threatening medical condition that affects over 1,300,000 patients in the U.S. annually. LB1148 may be used for the treatment of cardiovascular surgeries which can result in systemic hypoperfusion and cardiogenic shock, septic shock in severe sepsis cases, and trauma or heavy blood loss, which can lead to extremely low blood pressure and hypovolemic or hemorrhagic shock. Each of these represents large patient populations with high unmet medical need due to long term morbidity and high mortality rates.
Extensive preclinical animal data has demonstrated the efficacy of LB1148 across multiple animal models of shock. In collaboration with investigators, a phase 1 safety study was completed in 2013. This study tested the active components of LB1148 vs. a nontreated control in 49 cardiovascular surgery patients. Based on these findings we are now proceeding to Phase 2 proof of concept clinical trials in two key indications, cardiovascular surgery and septic shock. As a result of the Ebola Virus Disease, the company is also filing a Compassionate Use IND with the FDA focused on preventing and treating hypovolemic and hemorrhagic shock associated with Ebola Virus Disease. The addressable market for the full LBS suite of products is over $100B. More specifically, autodigestion contributes to disease in approximately 20 to 30 million people on a yearly basis. To develop that pipeline, LBS has established a world-class management team, as well as medical advisory panels, qualified to bring multiple blockbusters to the global marketplace to successfully address the adverse effects of autodigestion. LBS’s lead candidate is entering phase 2 clinical trials and continue to receive positive response from physicians. Recent interactions with the FDA indicate that our current clinical and regulatory path is viewed favorably.