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Novel Oral Therapeutic for Alcohol-Associated Hepatitis (AH)

Nterica Bio, Inc., a San Diego-based biotechnology company, is developing novel therapeutics for life-threatening, microbiome driven, inflammatory diseases. Our lead program is a precision therapeutic for treating patients with acute alcohol-associated hepatitis (AH) and is ready for clinical studies.

A growing health crisis

Alcohol-associated hepatitis is a severe, life-threatening form of liver disease that affects approximately 100,000 U.S. adults each year.

Alcohol-associated hepatitis is a severe and life-threatening form of liver disease. Our team has identified cytolysin—an exotoxin that is secreted specifically by Enterococcus faecalis (E. faecalis)—as a leading cause of hepatocyte death and liver injury.

Patients with alcohol-associated hepatitis have increased numbers of E. faecalis in the gut microbiome with the presence of cytolysin-positive E. faecalis leading to much higher patient mortality. We believe that reducing cytolysin producing E. faecalis in the gut may reduce liver damage and save patients lives. Our first clinical program, NTR-101, is a highly targeted oral bacteriophage therapeutic against cytolysin producing E. faecalis.

Preclinical experiments in humanized mice colonized with bacteria from the feces of patients with alcohol-associated hepatitis showed the therapeutic effects of our bacteriophages targeting cytolytic E. faecalis.  Our bacteriophages decreased cytolysin in the liver by specifically targeting cytolytic E. faecalis and eliminated ethanol-induced liver disease in the animals (Duan et al, 2019). Nterica Bio will run clinical trials to study the safety and efficacy of NTR-101 in patients with alcohol-associated hepatitis.

illustration of how alcohol consumption leads to E. faecalis outgrowth

scientific rationale

Direct link between gut microbiome dysfunction and liver disease.

Alcohol consumption disrupts and alters microbial communities, causing dysbiosis, where cytolysin-positive E. faecalis thrives. Alcohol consumption also causes disruption of the gut membrane (“leaky gut”), which releases cytolysin-positive E. faecalis into the systemic circulation. Translocation of the cytolysin toxin to the liver via the hepatic portal vein leads to the development and progression of liver disease. 

We are developing a precision therapy for life-threatening AH.

Patients with alcohol associated hepatitis have too many bacteria called E. faecalis in their gut. Some of these bacteria produce the toxin cytolysin (cytolysin positive E. faecalis) which damages liver cells frequently resulting in patient mortality. Nterica is developing a precision bacteriophage therapeutic which targets cytolysin positive E. faecalis to restore liver function and reduce patient mortality.

of cytolysin positive AH patients die within 6 months
0 %

Oral treatment

NTR-101: IND approved clinical ready asset for AH with potential follow on indications.

Minimal product changes from NTR-101 are expected for an effective treatment in cytolysin positive Graft versus Host Disease (GvHD).

Our Team

headshot of Bernd Schnabl

Bernd Schnabl, MD

Founder

headshot of Ian Hardy

Ian Hardy, MBA, PhD

CEO

headshot of Jeff Southerton

Jeff Southerton, MBA, PhD

Business Development

headshot of Sandra Morales

Sandra Morales, PhD

R&D Operations

headshot of Anita Busquets

Anita Busquets, MBA

Finance

Scientific Advisors

headshot of Bernd Schnabl

Bernd Schnabl, MD

headshot of Robert Schooley

Robert Schooley, MD

headshot of Mark Thursz

Prof. Mark Thursz

Contact us today.

Discover how our groundbreaking technology is transforming long-term effective treatments in AH — contact us today to learn more.

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Bernd Schnabl, MD

Founder

Bernd Schnabl, MD is a Professor of Medicine and Director of the San  Diego Digestive Diseases Research Center.  He is a board certified Physician-scientist at UCSD Medical Center & the VA Hospital San Diego.  He is the Founder of Nterica.

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Ian Hardy, MBA, PhD

CEO

Ian Hardy is a drug developer and biotech executive with strong business acumen and leadership skills honed over a 30-year career with mature pharmaceutical companies, emerging biotechs and most recently a healthcare investment firm in both R&D and operational roles. Ian’s large pharma career took in roles of increasing responsibility in pharmaceutical development at Glaxo, AstraZeneca and Merck. Ian then led Chemistry, Manufacturing and Controls (CMC) activities for a number of clinical stage biotechs, encompassing drug substance, drug product and clinical supply chain. At Deerfield, a blue-chip healthcare investment firm, Ian played a pivotal role in building a productive internal R&D engine, and supporting the incubation and growth of a number of portfolio companies in various operational roles. Whilst at Deerfield, Ian was Interim CEO and Chairman of the Board at Adaptive Phage Therapeutics (APT), a private clinical stage company developing bacteriophage therapeutics for severe and recalcitrant infections. At APT, Ian led a successful company exit through acquisition by BiomX, a publicly traded bacteriophage company.

Ian holds a PhD in Pharmaceutical sciences from the University of Nottingham (UK) and an MBA from the University of Warwick (UK).

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Jeff Southerton, MBA, PhD

Business Development

Jeff combines his scientific and business development backgrounds to help biopharma and life sciences companies grow and advance their pipelines.

He has 20 years’ experience as a Business Development professional in the pharmaceutical industry, including leading due diligence teams to identify and evaluate opportunities; negotiating the terms of and drafting the legal contracts underpinning research collaborations, technology and asset licensing deals; and managing the business aspects of alliances from start to end. He also has experience in the out-licensing of assets at all stages of clinical development. Jeff holds a PhD in pharmacology and an MBA.

Jeff has successfully concluded agreements with parties across the R&D spectrum – government, academic, biotech and large pharma.

Sandra Morales, PhD

R&D Operations

Sandra Morales is a microbiologist with specific doctoral expertise in molecular biotechnology and bacteriophage science. She has over 17 years of industrial experience developing bacteriophage-based products against a variety of pathogens, with an emphasis on clinical and manufacturing development. 

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Anita Busquets, MBA

Finance

Anita Busquets is a financial biotech executive.  She brings over 35 years of executive operational and financial experience as a CFO, raising capital and growing startups to successful exits.  

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Robert T. Schooley, MD

Dr. Schooley is a Distinguished Professor of Medicine in the Division of Infectious Diseases and Global Public Health at University of California San Diego. After medical school and residency at Johns Hopkins and infectious disease fellowships at the NIH and Massachusetts General Hospital, he joined the faculty of Harvard Medical School. His longer-term research efforts are directed at the pathogenesis and therapy of RNA virus infections.  Following his successful use of bacteriophages to treat a multidrug resistant A. baumannii infection in a fellow UCSD faculty member in 2016, he became interested in the use of viruses as therapeutic agents for bacterial infections. He currently Co-Directs UCSD’s Center for Innovative Phage Applications and Therapeutics (IPATH).

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Prof. Mark Thursz

Mark Thursz is professor of hepatology in the Division of Digestive Diseases and Head of the Department of Metabolism, Digestion & Reproduction in the Faculty of Medicine at Imperial College. Prof Thursz was educated at King’s College London and trained in Gastroenterology and Hepatology at Imperial College Healthcare NHS Trust. His early research work focussed on genetic susceptibility in viral hepatitis and the determinants of disease progression including the role of the coagulation system in hepatic fibrogenesis. In 2011 Prof Thursz launched the Prevention of Liver Fibrosis and Cancer in Africa (PROLIFCA) programme to address barriers to control and elimination of viral hepatitis in resource limited countries.

Prof Thursz runs a translation research programme in alcohol-related liver disease. He ran the Steroids or Pentoxifylline for Alcoholic Hepatitis (STOPAH) trial which explored the utility of existing treatments for alcoholic hepatitis and is now involved in a portfolio of trials in alcohol-related liver disease. Recently granted an MRC Stratified Medicine award he is now exploring novel biomarkers for diagnosis, prognosis and risk of infection in this condition.

Prof Thursz was Secretary-General of the European Association for Study of the Liver 2011-13. He is currently Director of the Imperial Biomedical Research Centre a £95M infrastructure award from the National Institute for Health Research to support research across multiple disciplines with the aim of translating fundamental research discoveries into the clinic. He is also Director of the Imperial Academic Health Science Centre.