Leading BioSciences Recieves FDA IND Clearance To Proceed With A Randomized, Multi-Center Phase 2 Clinical Trial Using LB1148 To Treat Septic Shock

Patient Enrollment to begin Q2 of 2015

SAN DIEGO, Feb. 2, 2015 /PRNewswire/ -- Leading BioSciences, Inc. (LBS) a privately held clinical-stage platform pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) gave LBS clearance to proceed on an Investigational New Drug Application (IND) for the clinical development of LB1148 in patients with septic shock and multi-organ failure.  The Company will begin a multi-center, randomized, double-blinded, placebo controlled, Phase 2 safety and efficacy study in patients with septic shock.  LBS plans to initiate enrollment of the "SSAIL" trial (Treatment of Septic Shock by Inhibiting Autodigestion and Preserving Gut Integrity with Enteric LB1148) in the second quarter of 2015.

"The FDA green light to conduct a well-designed Phase 2 safety and efficacy trial for LB1148 is a critical step in advancing our development plan," said Robin Jackman, Ph.D., CEO of Leading BioSciences.  "Septic shock and multi-organ failure are areas with major unmet medical needs. Our mission is to address this life threatening condition that currently has no approved treatment."

Septic shock results in a cascade of events that ultimately impact vital organ function, even organs not involved in the insult leading to shock.  Evidence indicates that after an extended period of shock, pancreatic digestive enzymes in the lumen of the small intestine are a major driver of multi-organ failure. LB1148 is a formulated, broad-spectrum serine protease inhibitor designed to inhibit the proteases driving multi-organ failure resulting from multiple forms of shock.  LB1148 is the first therapeutic targeting this specific mechanism for the treatment of shock in clinical trials.

"Shock induced ischemia leads to a gut submucosa which is vulnerable to intraluminal pancreatic proteolytic enzymes," said David B. Hoyt, M.D., FACS, Executive Director of the American College of Surgeons. "LB1148 is designed to attenuate the gut barrier breakdown consequences of shock, which is a critical part of multiple organ failure."

The purpose of the SSAIL trail is to assess the safety and efficacy of LB1148 in a septic shock patient population. To that end, the research hypothesis to be tested in this study is that enteral (oral) administration of LB1148 will result in clinically meaningful benefit to septic shock patients as reflected in an increase in the number of days alive without cardiovascular, renal or pulmonary organ support at Day 28.  Additional secondary measures of efficacy will focus on overall mortality, organ function and biomarkers.  The SSAIL trial is designed to enroll 250 patients experiencing septic shock at approximately 30 hospitals in the United States and Canada. 

The majority of sepsis studies over the past half-decade have enrolled a broad range of patients with sepsis severity, resulting in clinical trial mortality rates generally in the range of 18-25%, and an inability to distinguish treatment from placebo.  The SSAIL trial will be one of the first clinical trials of its kind aimed at enrolling a narrow range of shock severity.  The SSAIL trial is designed to exclude patients that have a high probability of recovery without therapeutic intervention as well as those who have a high probability of mortality.  The inclusion and exclusion criteria are designed to enroll a patient population with a greater than 40%+ mortality rate.  The primary endpoint of the SSAIL trial will assess if enteral administration of LB1148 will decrease the number of days that a patient requires organ support following septic shock and multi-organ failure.

"This IND clearance is the first of many exciting and upcoming milestones as we continue to advance LB1148 into Phase 2 clinical trials," said Thomas Hallam Ph.D., Vice President of Therapeutic Development.  "Due to its therapeutic potential in a number of diseases with high unmet need, we plan to expand the clinical program for LB1148.  Later this year, we plan to initiate a Phase 2 clinical trial to evaluate LB1148 to treat organ dysfunction associated with high-risk cardiovascular surgery."

About LB1148.

LB1148 is an investigational drug formulated to preserve gastrointestinal (GI) integrity during physiologic shock. When administered orally or enterally, LB1148 delivers key digestive enzyme inhibitors to the small intestine to help preserve the GI barrier during acute periods of shock.  After years of research, LB1148 was designed to provide three main functions: 1) inhibit key digestives enzymes that are believed to drive organ dysfunction, 2) promote transport of the inhibitor along the length of the digestive tract and 3) provide a balanced energy source to promote healing of the GI barrier.

About Shock and Multi-Organ Failure.

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.

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. Its pipeline includes a drug to treat gastrointestinal breakdown resulting from three common forms of shock: septic shock, cardiogenic shock following heart surgery, 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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