International NASH Day: Recent reports on awareness, pipeline

This year’s International NASH Day, led by the Global Liver Institute, is focused on the anticipated rise of nonalcoholic steatohepatitis in years to come and experts have highlighted key strategic issues to improve clinical management and health system preparedness from a policy perspective.

In support of International NASH Day, Healio Gastroenterology and Liver Disease presents the following reports NASH news from Digestive Disease Week, a survey that found low rates of awareness among the general public including those most at-risk, outcomes from the phase 3 trial of Ocaliva, and several others.

Discoveries from DDW: NASH

This resource center provides updates on the latest news from Digestive Disease Week on NASH, including identification of the disease, treatment and patient outcomes. Bookmark this page and visit often to learn more. Read more

Survey confirms NASH awareness remains low even among most at-risk

Results from a survey presented at the third annual NASH Summit in Boston showed that awareness of nonalcoholic steatohepatitis and nonalcoholic fatty liver disease remained low even among patients with the highest risk factors, according to a press release.

“Low public awareness of NASH and fatty liver disease is a barrier to clinical trial enrollment," Cathleen Dohrn, PhD, senior scientific director at Continuum Clinical, who presented the findings at the Summit, said in the release. “NASH clinical trial sponsors need thousands of patients in order to find the first treatment for this condition, which will necessitate increased awareness and diagnosis of NASH.” Read more

NetNoggin releases pharmaceutical development guide for NASH, NAFLD

The market research agency NetNoggin released its newest research known as NetNog: #genesis NASH, which includes data on nonalcoholic steatohepatitis and nonalcoholic fatty liver disease for pharmaceutical development, according to a press release.

The NetNog: #genesis program is foundational research grounded in “netnography,” which was described as unframed, unbiased online immersion in patient, caregiver and health care provider conversations and is supported with secondary research to provide context to the disease state. Read more

‘Watershed moment:’ Ocaliva improves NASH in phase 3 trial

Despite missing one of the two primary endpoints set with the FDA, Ocaliva produced antifibrotic effects in a dose-dependent manner in a large, prospective study of patients with nonalcoholic steatohepatitis presented during the International Liver Congress 2019.

“At the moment there is no treatment. This is a watershed moment in this field. This is the first randomized, clinical trial, large study that has shown efficacy,” Zobair M. Younossi, MD, chairman of the department of medicine at Inova Fairfax Medical Center, Fairfax, Virginia, said during a press conference. “We are at the beginning of what this disease is going to be as far as treatment. You’ll see combinations and combinations of combinations over the next few years. This is an exciting time but it’s the beginning of a great journey.” Read more

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FGF21 protein may predict severity of NASH in obesity, diabetes

Measurement of fibroblast growth factor 21, a protein widely expressed in the liver, may predict the severity of nonalcoholic steatohepatitis in adults with obesity or type 2 diabetes, according to findings published in The Journal of Clinical Endocrinology & Metabolism.

“Plasma fibroblast growth factor 21 (FGF21) correlates with severe steatohepatitis in patients with nonalcoholic steatohepatitis (NASH), and in particular, fibrosis, the most important feature that determines the progression of disease,” Kenneth Cusi, MD, FACP, FACE, professor of medicine and chief of the division of endocrinology, diabetes and metabolism at the University of Florida and Endocrine Today Editorial Board member, said in an interview. “We also saw that, as patients become more insulin resistant in muscle and adipose tissue, they had higher levels of FGF21. This protein could potentially identify those at the highest risk for disease progression.” Read more

VIDEO: Genfit promotes NASH awareness as equally important as therapy

In this exclusive video from the International Liver Congress 2019, Dean Hum, PhD, chief scientific officer and chief operating officer of Genfit, discusses the company’s therapeutic and diagnostic pipeline as well as efforts toward disease awareness.

“Genfit, as a leader in the whole NASH space, we're involved in the key unmet needs ... in the whole NASH space,” Hum told Healio Gastroenterology and Liver Disease. “One is developing drugs and addressing the therapy of NASH patients and we’re looking at that by moving elafibranor forward. The other major unmet need is, of course, diagnostics.” Read more

MRI-PDFF suboptimal in identifying advanced NASH, fibrosis

Results of a study on liver histology features in patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis revealed that magnetic resonance imaging-estimated proton density fat fraction was suboptimal in identifying patients with advanced NASH or fibrosis.

“While MRI-PDFF is a useful tool for the non-invasive detection of NAFLD and quantification of steatosis, we found that PDFF was not accurate enough to distinguish between NAFLD, NASH with early fibrosis, and NASH with advanced fibrosis in individual patients,” Benjamin Wildman-Tobriner, MD, from Duke University Medical Center in North Carolina, and colleagues wrote. Read more

FibroScan after endoscopy found undiagnosed NAFLD, NASH

FibroScan screening for nonalcoholic fatty liver disease and nonalcoholic steatohepatitis could significantly improve patient diagnosis and care, as data presented at the American College of Gastroenterology Annual Meeting showed that FibroScan found a significant number of undiagnosed cases.

“Nonalcoholic fatty live disease and nonalcoholic steatohepatitis are largely undiagnosed until later stages in which symptoms appears,” Woodie M. Zachry III, PhD, RPh, from Quantym Therapeutic Data in Florida, said during his presentation. “This sets up a paradigm that early detection and intervention are necessary.” Read more