Leading Biosciences Launches Gastrobiome™ Focused Product Development Strategy to Harness Microbiome Ecosystem in the Gastrointestinal Tract

SAN DIEGO, Sept. 20, 2016 /PRNewswire/ -- Leading BioSciences Inc., a pioneer in therapies for gastrointestinal (GI) mucosal barrier breakdown related diseases, announced today the launch of a new product category of novel therapeutics and diagnostics for targets within the GI tract category called the Gastrobiome™.

Leading BioSciences defines the gastrobiome as the entire ecosystem of the gastrointestinal tract, including the environment, barriers, tissues, mucus, mucin, enzymes, nutrients, food and communities of microorganisms that reside in the gastrointestinal tract. Of critical importance is how the integrity and permeability of the intestinal mucosal barrier impact health.

The company is focused on treating the effects of intestinal mucosal barrier breakdown within the gastrobiome, which includes leaking endogenous enzymes and bacterial toxins that have a daily impact on acute and chronic human health conditions such as severe shock, multi-organ failure, ileus, adhesions, obesity, diabetes, hypertension, insomnia, metabolic syndrome and autism. Currently, there are no FDA-approved products designed to restore the microbiome, nor any component of the gastrobiome, to a healthy state. Leading BioSciences is currently advancing three Phase 2 clinical trials in acute conditions and is now preparing to launch multiple chronic related therapeutics into the clinic during 2017.

"This new product strategy is about speeding up the timing of clinical development for Leading BioSciences' existing long-term product pipeline and expanding into new opportunities within the gastrobiome. Our company has been pioneering research on the 'gut-motor hypothesis' for more than a decade now. This move is about defining a new ecosystem and then advancing our product pipeline within that category in the clinic as appropriate," said Greg Doyle, CEO of Leading BioSciences. "With our gastrobiome product development strategy, we are making aggressive moves expanding our product development efforts into areas of high value that have potential for treating serious chronic conditions. This focus will create a depth and breadth to our pipeline that is currently unmatched in the field."

Thomas Hallam, Ph.D., senior vice president, Clinical Development and Regulatory Affairs, added: "The most important aspect of the gastrobiome is the permeability of the mucosal barrier, which traps the disease causing elements in the small intestine while allowing essential nutrients to cross the barrier for absorption by the body. Our research has demonstrated that the barrier can become leaky, allowing small amounts of disease causing elements through the barrier and driving chronic diseases such as diabetes and hypertension. Furthermore, the barrier can fail suddenly, like water breaking though a levee, causing a medical crisis such as multiorgan failure. Given our unique understanding of the intestinal mucosal barrier, we can develop gastrobiome-focused drugs to improve patient lives."

As it expands its gastrobiome product strategy, Leading BioSciences will continue to advance its lead, product candidate, LB1148, through Phase 2 clinical studies for ileus and adhesions, cardiovascular surgery complications, severe shock and multi-organ failure.

About the Gastrobiome

For decades, researchers have investigated the human microbiome, composed of the bacteria, microbes, genes and genomes that live in and on our bodies, and its role in human health. This includes all areas where bacteria and microbials live, grow and exist, in areas such as the skin, mouth, GI tract, genitourinary tract and lungs. The microbiome focuses on the trillions of species of bacteria and microbials that exist in the body. Most species are harmless, or even helpful, under normal circumstances. There is also a large part of today's microbiome effort that is devoted to sequencing, analyzing, and data storage of the individualized human microbiome. 

Leading BioSciences believes that the most critical and impactful microbiome ecosystem resides in the gastrointestinal tract, which contains a combination of barriers, tissues, mucus, mucin, enzymes, nutrients, food and communities of microorganisms that become the driver of multiple medical conditions when disrupted. Of primary importance is the contribution of these organisms within the small and large intestines, and the barriers that maintain them within the intestinal tract. The intestines comprise the majority of the surface area in the GI tract and represents where the majority of digestion and absorption occurs. Leading BioSciences refers to this ecosystem, as well as the tissues and barriers that protect the rest of the body from these potent elements, as the Gastrobiome.

About the Gastrobiome Product Strategy

Leading BioSciences Gastrobiome product strategy is rooted in the company's extensive research showing the gastrointestinal tract and the intestinal mucosal barrier are the foundation of human health. Based on proprietary pharmacological knowledge of the intestinal mucosal barrier, as well as the mucin layer within the small intestine, the company's product pipeline targets specific therapeutic opportunities within the Gastrobiome. On the therapeutics side, the company will focus on treating conditions such as ileus, adhesions, severe shock, multi-organ failure, obesity, diabetes, high-cholesterol, hypertension, insomnia, metabolic syndrome, autism and numerous additional conditions.  In 2017, the company expects to nominate its first gastrobiome therapeutic candidates for clinical development. To complement its emerging gastrobiome therapeutic pipeline, the company plans to develop and commercialize novel diagnostic technologies, such as blood assays for mucosal barrier integrity and tools for gastrointestinal imaging, to identify  patients with gastrobiome-related disorders. 

About Leading BioSciences

Leading BioSciences is a biopharmaceutical company pioneering new approaches to address conditions and diseases related to gastrointestinal mucosal barrier breakdown. The company has leveraged its deep scientific understanding of the GI tract, the intestinal mucosal barrier and the Gastrobiome™ — a rich ecosystem with numerous druggable therapeutic targets within the human microbiome — to develop a broad pipeline of programs to address critical-care conditions and chronic, daily-maintenance health issues, complemented by an emerging Gastrobiome™ diagnostic platform. The company's clinical development is supported by a robust base of positive preclinical outcomes, $23 million in private capital and more than $22 million in foundational research backed by the National Institutes of Health. Leading Biosciences is privately held and maintains corporate headquarters in San Diego.  Visit www.leadingbiosciences.com for additional information.

SOURCE Leading BioSciences Inc.

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