NASH update: Expert opinions on awareness, potential therapeutics

Many experts consider the rising rates of nonalcoholic steatohepatitis to be nearing “epidemic levels” and, as such, will require increased awareness among both physicians and patients regarding lifestyle intervention and potential new treatments and diagnostics.

Healio Gastroenterology and Liver Disease presents the following recent reports on NASH, including an expert editorial on lifestyle intervention, recent pipeline updates, and the outcomes of using multiple noninvasive test to best identify NASH-related fibrosis.

Stopping NASH in its tracks: Lifestyle Intervention Key from Day 1

In this guest editorial, Joel E. Lavine, MD, PhD, chief of pediatric gastroenterology, hepatology, and nutrition at the Columbia College of Physicians and Surgeons , discusses the future of treating nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, as these epidemics accompany with increasing obesity prevalence. He explains that even with upcoming therapeutics and noninvasive screening methods, appropriate diet and exercise are vital to avoiding and treating these diseases. Read more

CymaBay hopeful for seladelpar despite missing one trial endpoint

Interim data from an ongoing phase 2b trial of CymaBay’s seladelpar as a treatment for nonalcoholic steatohepatitis showed that the PPAR agonist did not reduce hepatic fat compared with placebo, but did show significant reductions in transaminase levels, according to Sujal Shah, president and CEO of the company.

At 12 weeks, alanine aminotransferase decreased by 25% to 37.5% in patients who received 10 mg or 15 mg of seladelpar and by approximately 32 U/L in those who received 50 mg. Similarly, gamma-glutamyl transferase decreased by 28% to 43% in the 10 mg and 15 mg groups. Read more

Liver health advocates declare NASH a ‘hidden epidemic’

As liver health advocates continue seeking opportunities to increase public awareness about liver diseases, the Global Liver Institute declared nonalcoholic steatohepatitis a “hidden epidemic” as they led this year’s International NASH Day.

“We feel an urgent need to raise awareness for and educate on nonalcoholic fatty liver disease and nonalcoholic steatohepatitis so that these liver diseases are included in every health care conversation when obesity and diabetes are mentioned,” Donna R. Cryer, JD, president and CEO of the Global Liver Institute, said in a press release. “We are spearheading a global effort for adoption of non-invasive tests so that early detection and diagnosis of these diseases is easier, and we can begin to stem the tide of this global epidemic.” Read more

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Multiple noninvasive test procedure identifies NASH-fibrosis

Fibrosis-4 index followed by measurement of liver stiffness with vibration-controlled transient elastography or Enhanced Liver Fibrosis test maintained acceptable noninvasive performance in identifying advanced fibrosis due to nonalcoholic steatohepatitis while reducing the rate of indeterminate results, according to an analysis of the STELLAR trial outcomes.

“Even the most effective treatment will not be able to address this large unmet medical need without a practical method to identify patients most in need of treatment,” Quentin M. Anstee, PhD, from Newcastle University in the United Kingdom, and colleagues wrote. “Such a method would have the additional benefit of reducing unnecessary drug exposure and costs in patients least likely to benefit from therapy.” Read more

NASH PASS clinical trial enrollment initiative gains partner

High Point Clinical Trials Center announced a 3-year collaboration with ProSciento to join NASH PASS as a site partner, according to a press release.

NASH PASS is Prosciento’s program designed to combine select qualified sites and a proprietary methodology to improve enrollment outcomes in nonalcoholic steatohepatitis clinical trials. Read more