Leading BioSciences Submits Expanded Access, Compassionate Use IND For LB1148 To Treat Ebola-Related Shock And Multi-Organ Failure
LB1148 May Help Patients Survive Deadly Organ Failure to Fight Off Ebola Virus
SAN DIEGO, Nov. 6, 2014 /PRNewswire-USNewswire/ -- 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. The company has submitted an expanded access Investigational New Drug application (IND) with the U.S. Food and Drug Administration (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 percent, 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 6 and 16 of complications including hemorrhagic shock and septic shock which lead to multi-organ failure.
"At Leading BioSciences, we recognize the urgency and need to respond to the recent Ebola outbreak, understanding that LB1148 may be able to reduce multi-organ failure resulting from hypovolemic, hemorrhagic and septic shock in severe Ebola patients," said Robin M. Jackman, PhD, chief executive officer of Leading BioSciences. "We have submitted an application to the FDA to allow investigators access to the drug in order to place LB1148 in the hands of doctors who can make a difference in Ebola patients' battle to survive."
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 1 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 percent to more than 90 percent.
By year end, Leading BioSciences intends to submit a conventional IND application for two Phase 2 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.
This information concerns a use that has not been approved by the FDA.
About Leading BioSciences, Inc.
Leading BioSciences 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 breakdown resulting from three common forms of shock: cardiogenic shock following heart surgery, septic shock and hemorrhagic shock.
Leading BioSciences' lead product, LB1148, is the result of 10 years of research and testing. The drug is a therapy designed to prevent the onset of shock and multi-organ failure through direct administration of a proprietary formulation into the stomach and intestine. For additional information on Leading Biosciences, please visit www.leadingbiosciences.com.
SOURCE Leading BioSciences, Inc.
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