According to a recent article in Hepatology, the Journal of the American Association of Liver Diseases, “The scale of the non‐alcoholic fatty liver disease (NAFLD) epidemic is staggering. It is estimated that 24 percent of the world’s people have NAFLD. By the year 2030, the United States will have approximately 100 million individuals with NAFLD leading to a higher incidence of decompensated cirrhosis, hepatocellular carcinoma (HCC), and liver-related death.”
Recent news reports indicate an increase in activity in the search for diagnostics, treatments, and potential cures for NAFLD.
Knowledge graph of NAFLD with associated areas of research, relationships between those areas, and strength of those connections (a darker line between terms means a greater strength of connection, while a lighter line means a lesser strength of connection)
In August, Siemens Healthineers’ Enhanced Liver Fibrosis (ELF™) Test was granted marketing authorization by the FDA under the De Novo review pathway. This test is the first for patients with advanced fibrosis due to NASH. ELF helps assess patients’ likelihood of progressing to cirrhosis and other liver-related issues, and was granted Breakthrough Device Authorization by the FDA in late 2018.
In July, leading hepatology researchers announced important new developments in the treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) at the International Liver Congress 2021 (ILC 2021) today. This includes new data on trials involving RNAi therapeutics, antivirals and structurally engineered fatty acids to treat NAFLD which is now one of the fastest growing diseases globally.
There has also been an increase in research on biomarkers related to NAFLD. The Resolute Research Report presents data on recent developments in identification of biomarkers in the area of NAFLD.
Patent activity in the development of treatments for NAFLD has been gaining momentum over the past few years. The chart below looks the same for NASH-related patents, as well as patents combining NAFLD and NASH specifically involving biomarkers.
NAFLD Patent Activity 2012 - 2021
There has been especially strong growth in patents at the intersection of biomarkers and NAFLD. Leading corporate patent assignees in this area include Metabolon, Genfit, and Somalogic, mentioned below.
Leading corporate patent assignees at the intersection of biomarkers and NAFLD
Somalogic, a protein biomarker discovery and clinical diagnostics has 13 patents overall and a leading patent covering biomarkers and NAFLD. The map below illustrates the range of Somalogics biomarker research as reflected by their patent portfolio.
Network graph showcasing the range of Somalogics biomarker research as reflected by their patent portfolio
NAFLD Clinical trials
A sample of clinical trials at the intersection of biomarkers and NAFLD disease and their sponsors. Perspectum’s LiverMultiScan is a “suite of metrics designed to meet the growing demand for liver diagnostics. LiverMultiScan gives physicians key indications of liver tissue characteristics to empower their diagnostic and patient management decisions.”
A sample of clinical trials at the intersection of biomarkers and NAFLD disease and their sponsors
ResoluteAI applies MeSH descriptors to PubMed articles to facilitate drill-down into specific areas of interest.
PubMed publications involving biomarkers and NAFLD disease and their mesh headings
This network graph illustrates the intersection of publications with specific MeSH headings and chemical compounds mentioned in each article which facilitates and accelerates the research process.
NAFLD publications with specific MeSH headings and chemical compounds mentioned in each article
There have been 48 grants awarded since the beginning of the year from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of General Medical Sciences, and the National Institute of Aging. Of these, six are focused on biomarkers.
Recipients of grants from the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of General Medical Sciences, and the National Institute of Aging involving NAFLD
NAFLD Tech transfers
There are two recently posted tech transfer opportunities that focus on liver disease and biomarker, one at Stanford and the other at UCSF.
|Diagnosing Liver Cancer in Patients with Cirrhosis||Researchers at Standford have identified methylated cell-free DNA biomarkers that can be used to determine if a cirrhosis patient has hepatocellular carcinoma (HCC). The method they have developed, called Layered Analysis from Methylated Biomarkers (LAMB), incorporates methylation data from 3411 HCC…||Stanford University||
|Anti-Human SULF2 monoclonal antibodies for research applications||Invention Novelty Sulfatase 2 (SULF2) is an extracellular sulfatase that acts on heparan sulfate proteoglycans. It is overexpressed and pro-oncogenic in many cancers. Its overexpression the liver is linked to the dyslipidemia and fatty liver disease. This invention describes a panel of…||University of California-San Francisco||
NAFLD focused Companies
Some recently established companies focused on NAFLD, from CrunchBase:
Phyteau is developing completely safe and effective therapeutics to give people control over their metabolism, blood sugar and weight. Our approach represents a new class of incretin-based therapy for diabetes, obesity and related metabolic conditions like NASH, NAFLD and prediabetes. Unlike many treatments in the market today, we can produce treatments that are completely safe, non-toxic and free of adverse side-effects. Founded 1-1-2017.
Akero Therapeutics is committed to providing meaningful treatment options for people with serious metabolic diseases like non-alcoholic steatohepatitis (NASH), a disease marked by inflammation in the liver and liver cell damage resulting in fibrosis, cirrhosis, liver failure, and death. The company is developing pioneering medicines designed to restore metabolic balance and halt NASH progression. Akero's lead clinical program, AKR-001, is a long-acting Fc fusion modified FGF21 protein and potential best-in-class treatment for NASH. The AKR-001 builds upon two decades of work on FGF21 biology. It is designed to affect both the liver and adipose tissue, reducing liver fat and suppressing inflammation and fibrosis. Founded 1-1-2017
Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
Akarna Therapeutics is a biopharmaceutical company (UK) that is developing novel small molecule therapeutics that target inflammatory and fibrotic diseases. Our lead program is a non-bile acid FXR agonist that is potentially a best-in-class therapeutic for the treatment of nonalcoholic steatohepatitis (NASH), a progressive form of fatty-liver disease for which there are no approved therapies. Akarna’s lead candidate is currently in preclinical, IND-enabling toxicology and safety pharmacology studies with first-in-human studies planned for early 2017.
DayTwo is a precision nutrition company that uses food as medicine to enable a path to remission for metabolic diseases including diabetes, prediabetes, clinical obesity, NAFLD. DayTwo's groundbreaking scientific discovery, published in CELL (2015) and JAMA (2019) determined that people respond differently to the same food, thus knowing what food “works” for each person is crucial to an effective care plan. DayTwo uses gut microbiome sequencing (stool sample, akin to Cologuard) to create Food Prescriptions™ for each patient which balance blood sugar levels, improve energy, manage hunger, and help members lose weight.
Pliant Therapeutics is a clinical stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis. Pliant's lead product candidate, PLN-74809, is an oral small-molecule dual selective inhibitor of avß6 and avß1 integrins that it is developing for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. PLN-74809 has received Orphan Drug Designation from the U.S. Food and Drug Administration for both IPF and PSC.
The network graph below highlights leading academic researchers in the NAFLD space and their home university.
Leading academic researchers in the NAFLD space and their home university
Progress in biomarkers in both the commercial and academic arenas is being applied to a NAFLD, an increasingly common, debilitating disease that often leads to more serious ailments. Almost all research areas covered by ResoluteAI - patents, clinical trials, academic publications, grants, and more, are showing significant increase in activity. New company formation specifically targeted at NAFLD (as per Crunchbase) has been limited but this is likely due to established companies focusing more intensively on the disease.
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