Leading BioSciences, a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock, has submitted an expanded access Investigational New Drug application (IND) with the FDA— also known as "compassionate use"—for its lead product LB1148.
LB1148 is an investigational drug centered around a broad-acting protease inhibitor designed to preserve the intestine during physiologic shock. 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. It may decrease the lethality of Ebola by treating these fatal symptoms and allowing patients time for their own systems to respond and clear the virus.
Ebola virus infections result in a severe form of viral hemorrhagic fever with fatality rates as high as 90%, with no curative treatments currently available. Patients who contract Ebola typically die from prolonged periods of shock brought on by the virus, not from the virus itself. According to the Centers for Disease Control and Prevention, patients with the fatal disease die typically between days six and 16 of complications including hemorrhagic shock and septic shock, which lead to multi-organ failure.
LB1148 was formulated to preserve GI integrity during physiologic shock, as can occur after trauma, cardiovascular events or acute infections. With years of research and a well-characterized safety profile, LB1148 was designed to provide three main functions: 1) inhibit key digestives enzymes, 2) promote transport of the inhibitor along the length of the digestive tract and 3) provide an important energy source to promote healing of the GI barrier. When administered orally or through nasogastric tube, LB1148 delivers key digestive enzyme inhibitors to the small intestine to help preserve the GI barrier during acute periods of shock.
Under informed consent, this treatment strategy has already been used in more than 200 patients in Taiwan, including a phase I safety study with no related safety issues reported. In other trials with the active ingredient, thromboembolic events and allergic reactions have been reported. Strong preclinical data shows that LB1148 improves morbidity and mortality following shock. In a preclinical study of hemorrhagic shock, the drug improved survival from 20% to more than 90%.
By year end, Leading BioSciences intends to submit a conventional IND application for two phase II clinical trials of LB1148 in multi-organ failure in septic shock and cardiogenic shock as a result of cardiovascular surgery, with trials initiating in early 2015. Both will be multi-center, randomized, double-blind, placebo-controlled trials.