Leading BioSciences Inc. (LBS) is a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock. Our pipeline includes a drug to treat gastrointestinal (GI) breakdown resulting from three common forms of shock: cardiogenic shock following heart surgery, septic shock and hemorrhagic/hypovolemic shock.
Severe, Acute Shock is a life-threatening medical condition with over 1,300,000 cases in the U.S. annually. Globally, severe shock and multi-organ failure kills over 2,000,000 people annually. The company’s lead product, 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.
The development of LB1148 is the result of over 15 years of research and testing. This investigational drug is centered around a broad-acting protease inhibitor designed to preserve the intestine during physiologic shock. LB1148 is being investigated for use as a therapy for treating multi-organ failure brought on by cardiogenic shock following heart surgery, hypovolemic, hemorrhagic and septic shock. Additionally, this product is targeted as a therapy for treating gastrointestinal (GI) breakdown and multi-organ failure that often result from hypovolemic or hemorrhagic shock experienced by severe Ebola patients.
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 45 cardiovascular surgery patients. Based on these findings we are now proceeding to Phase 2 proof of concept clinical trials in two key indications, cardiogenic shock following heart surgery and septic shock. Following recent dialogue with the FDA, LBS will be submitting a conventional IND for LB1148 to treat multi-organ failure linked to hypovolemic, hemorrhagic or septic shock caused by Ebola. In the meantime, LBS will continue to support access to LB1148 when requested by clinicians on an individual basis, using expanded access mechanisms, also known as “compassionate use,” which may allow access to LB1148 outside of clinical trials.
The addressable market for the full LBS platform of therapies and diagnostics is over $100B. More specifically, GI breakdown 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 this mechanism.