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HOST Therabiomics’ Investigational Compound, HOST-G904, Shown to Enhance Gut Microbiome Independent of Dietary Changes

Data validates microbiome as a potential treatment pathway for serious bowel conditions

JERSEY, UNITED KINGDOM, January 17, 2017 – HOST Therabiomics, a microbiome-based therapeutics company, today announced positive results from a proof-of-concept trial for its investigational compound, HOST-G904. The study, published in the journal Alimentary Pharmacology & Therapeutics, demonstrated that HOST-G904 enriched the gastrointestinal (GI) microbiome in healthy volunteers without needing to make any dietary changes. In the study, long-term (≥ 21 days) use of HOST-G904 did not result in sustained, gas-related abdominal symptoms (p=0.001) typically associated with prebiotics used to manage symptoms of functional gut disorders, including irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD).

“These results show the potential for HOST-G904 to improve the gastrointestinal microbiome without causing discomforting GI symptoms often associated with other treatments for functional gut disorders," said Graham Waters, CEO of HOST Therabiomics. “HOST-G904 is designed to optimize the gut microbiome and support the immune system’s defenses against certain diseases, and may offer new hope for patients impacted by IBS, IBD and other gut disorders. Based on these positive results, HOST Therabiomics will further analyze this compound in a Phase 2b study.”

Patients with functional gut disorders typically are first placed on a low FODMAP (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) diet, which heavily restricts sugars, lactose and other compounds that may contribute to negative GI symptoms. The open-label, single-arm study, conducted at the University Hospital, Vall d’Hebron Barcelona, Spain, included 26 healthy volunteers who did not have GI symptoms or a history of GI disorders, and were not required to change their diets during treatment. In the study, 20 participants were included in the main evaluation and six were included as control subjects.

Participants in the main study were given HOST-G904 (2.8 g/day) for three weeks, during which time they followed their usual diet. In the evaluation periods (three-day periods immediately before, at the beginning and at the end of the administration), the participants followed a standardized low-fiber diet with one portion of high-fiber foods, at which time the investigators measured the following: (1) number of daytime gas evacuations for two days; (2) volume of gas evacuated; and (3) microbiome composition (as measured by fecal Illumina MiSeq sequencing).

While HOST-G904 significantly increased gas-related symptoms at the beginning of treatment, these effects substantially diminished and returned to the pre-administration level after three weeks of use. At day 21, increased levels of butyrate-producing bacteria, including lachnospiraceae and clostridiaceae, were associated with lower volumes of gas-related symptoms. Butyrate is a type of fatty acid that plays a critical role in the proper functioning of the digestive system by controlling the growth of the cells lining the gut as well as regulating the production of immune cells in the colon.

“While low FODMAP diets can be effective for people with IBS and other GI disorders, they are extremely rigid to follow and have been criticized in recent years for negatively impacting the microbiome,” said Fernando Azpiroz, MD, PhD, Chief of the Department of Digestive Diseases at the University Hospital Vall d’Hebron, Autonomous University of Barcelona, Spain and lead author of the study. “In previous studies, HOST-G904 has been shown to improve IBS symptoms in patients, which was attributed to beneficial changes in the gut microbiome. Our new findings further reinforce the body of evidence supporting the clinical implications of this compound as a potential alternative therapy for functional GI disorders.”

About HOST-G904

HOST-G904 is an investigational compound designed to optimize the gut microbiome and support the immune system and protect against certain pathogens. It is part of the portfolio of optimized bio-manufactured compounds developed by HOST Therabiomics that are designed to harness the interactions between the microbiome and the immune system to prevent or treat conditions, ultimately benefiting the health of the host.

About HOST Therabiomics

HOST Therabiomics is a global, clinical stage microbiome-based therapeutics company that has been working for more than a decade to apply its understanding of the human host-microbiome interaction to modify, treat and prevent disease by targeting the broader set of interactions that occur at the host+biome intersection.

This host+biome approach has resulted in the development of multiple optimized bio-manufactured compounds, including lead candidate HOST-G904, that are designed to benefit the health of the host, and prevent or treat infectious, inflammatory and metabolic diseases, as well as neurological disorders.

HOST Therabiomics has successfully completed Phase 1 and 2 studies demonstrating the clinical benefit of HOST-G904 in traveler’s diarrhea and it is currently being evaluated in a Phase 2 study in IBS.

In 2017, the Company will be moving into Phase 3 studies, investigating the impact of HOST-G904 in specific populations for the treatment of traveler’s diarrhea. The company will also continue to explore the use of this microbiome-focused therapeutic, as well as additional candidates, for indications in other areas, including infectious and inflammatory and metabolic diseases, as well as neurological disorders.