NASH update: 6 recent reports on treatment development

Researchers continue efforts to study and develop safe and effective therapeutics to treat nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, including several collaborative efforts between clinical development companies and societies.

Healio Gastroenterology and Liver Disease presents the following reports on recent NASH studies including data on a newly formed “NASH Roundtable,” positive results from recent clinical trials, and a new LiverMultiScan tool for identifying NASH.

Vitamin E lowers mortality, transplant rates in patients with NASH

Vitamin E supplementation correlated with lower rates of all-cause mortality, liver transplantation and development of hepatic decompensation in patients with nonalcoholic steatohepatitis and advanced fibrosis, according to a study published in Hepatology.

“Beyond antioxidant effects, vitamin E has also been implicated in the regulation of inflammatory response via several enzymes involved in signal transduction as well as expression of specific genes closely related to inflammatory pathways, cellular trafficking and proliferation,” Eduardo Vilar-Gomez, MD, PhD, from the Indiana University School of Medicine, and colleagues wrote. Read more

ProSciento forms NASH Roundtable of experts to guide clinical research

ProSciento organized and funded the formation of the “NASH Roundtable,” a collaborative forum of leading academic and clinical developments experts designed to advise drug development programs, according to a press release.

“Nonalcoholic steatohepatitis is a serious disease with currently no approved therapies for patients, in part while the scientific and clinical research communities are still working towards robust clinical and regulatory development frameworks,” Marcus Hompesch, MD, CEO of ProSciento, said in the release. Read more

New LiverMultiScan mapping tool identifies NASH

Perspectum Diagnostics released details regarding the latest version of its LiverMultiScan magnetic resonance imaging technology which identified nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, according to a press release.

The latest version of LiverMultiScan will feature machine learning-based, automatic segmentation of cT1 and proton density fat fraction parametic maps of the liver parenchyma and be accessible on more field strengths across major scanner manufacturers. Read more

Thyroid receptor agonist shows sustained response in NASH

A novel thyroid receptor agonist — MGL-3196 — showed a sustained reduction in liver fat and other markers of nonalcoholic steatohepatitis in a 36-week study, according to data presented at The Liver Meeting 2018.

“Ultimately, we saw sustained statistically significant reduction in liver fat on MRI-PDFF compared with placebo, sustained statistically significant lowering of multiple atherogenic lipids including as well as statistically significant lowering and normalization of serum liver transferases and, overall, well tolerated and safe,” Stephen A. Harrison, MD, of the University of Oxford, said during his presentation. “There was statistically significant resolution of NASH that is correlated with reduction in liver fat on MRI-PDFF and we believe this provides evidence to move forward to a registrational phase 3 trial.” Read more

Aramchol reduces liver fat, improves histology in NASH

Results from a phase 2b trial showed that Aramchol— a stearoyl coenzyme desaturase A inhibitor — significantly reduced liver fat and improved histology with excellent safety and tolerability in patients with nonalcoholic fatty liver disease, according to data presented at The Liver Meeting 2018.

“Aramchol is a novel, first in class SCD1 modulator, targeted to the liver to reduce liver fat and collagen production,” Vlad Ratziu, MD, from Sorbonne University in France, said in his presentation. “In 1 year of study, Aramchol showed liver fat reduction, biochemical improvement, NASH resolution and fibrosis reduction in a dose response pattern.” Read more

NGM282 shows equivalent efficacy in NASH at lower dose

Although previously reported effective at a 3 mg dose, NGM282 showed similar efficacy in treating nonalcoholic steatohepatitis at 1 mg, according to data presented at The Liver Meeting 2018.

“NGM282 demonstrates improvement across histologic and noninvasive endpoints in NASH. There’s potent target engagement with C4 suppression and bile acids. There’s significant meaningful reductions across all noninvasive markers of NASH-related disease. And, ultimately, we see unprecedented antifibrotic activity at week 12 with both the 1 mg and 3 mg dose,” Stephen A. Harrison, MD, of University of Oxford, said during his presentation. Read more

Researchers continue efforts to study and develop safe and effective therapeutics to treat nonalcoholic fatty liver disease and its progressive form, nonalcoholic steatohepatitis, including several collaborative efforts between clinical development companies and societies.

Healio Gastroenterology and Liver Disease presents the following reports on recent NASH studies including data on a newly formed “NASH Roundtable,” positive results from recent clinical trials, and a new LiverMultiScan tool for identifying NASH.

Vitamin E lowers mortality, transplant rates in patients with NASH

Vitamin E supplementation correlated with lower rates of all-cause mortality, liver transplantation and development of hepatic decompensation in patients with nonalcoholic steatohepatitis and advanced fibrosis, according to a study published in Hepatology.

“Beyond antioxidant effects, vitamin E has also been implicated in the regulation of inflammatory response via several enzymes involved in signal transduction as well as expression of specific genes closely related to inflammatory pathways, cellular trafficking and proliferation,” Eduardo Vilar-Gomez, MD, PhD, from the Indiana University School of Medicine, and colleagues wrote. Read more

ProSciento forms NASH Roundtable of experts to guide clinical research

ProSciento organized and funded the formation of the “NASH Roundtable,” a collaborative forum of leading academic and clinical developments experts designed to advise drug development programs, according to a press release.

“Nonalcoholic steatohepatitis is a serious disease with currently no approved therapies for patients, in part while the scientific and clinical research communities are still working towards robust clinical and regulatory development frameworks,” Marcus Hompesch, MD, CEO of ProSciento, said in the release. Read more

New LiverMultiScan mapping tool identifies NASH

Perspectum Diagnostics released details regarding the latest version of its LiverMultiScan magnetic resonance imaging technology which identified nonalcoholic fatty liver disease and nonalcoholic steatohepatitis, according to a press release.

The latest version of LiverMultiScan will feature machine learning-based, automatic segmentation of cT1 and proton density fat fraction parametic maps of the liver parenchyma and be accessible on more field strengths across major scanner manufacturers. Read more

Thyroid receptor agonist shows sustained response in NASH

A novel thyroid receptor agonist — MGL-3196 — showed a sustained reduction in liver fat and other markers of nonalcoholic steatohepatitis in a 36-week study, according to data presented at The Liver Meeting 2018.

“Ultimately, we saw sustained statistically significant reduction in liver fat on MRI-PDFF compared with placebo, sustained statistically significant lowering of multiple atherogenic lipids including as well as statistically significant lowering and normalization of serum liver transferases and, overall, well tolerated and safe,” Stephen A. Harrison, MD, of the University of Oxford, said during his presentation. “There was statistically significant resolution of NASH that is correlated with reduction in liver fat on MRI-PDFF and we believe this provides evidence to move forward to a registrational phase 3 trial.” Read more

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Aramchol reduces liver fat, improves histology in NASH

Results from a phase 2b trial showed that Aramchol— a stearoyl coenzyme desaturase A inhibitor — significantly reduced liver fat and improved histology with excellent safety and tolerability in patients with nonalcoholic fatty liver disease, according to data presented at The Liver Meeting 2018.

“Aramchol is a novel, first in class SCD1 modulator, targeted to the liver to reduce liver fat and collagen production,” Vlad Ratziu, MD, from Sorbonne University in France, said in his presentation. “In 1 year of study, Aramchol showed liver fat reduction, biochemical improvement, NASH resolution and fibrosis reduction in a dose response pattern.” Read more

NGM282 shows equivalent efficacy in NASH at lower dose

Although previously reported effective at a 3 mg dose, NGM282 showed similar efficacy in treating nonalcoholic steatohepatitis at 1 mg, according to data presented at The Liver Meeting 2018.

“NGM282 demonstrates improvement across histologic and noninvasive endpoints in NASH. There’s potent target engagement with C4 suppression and bile acids. There’s significant meaningful reductions across all noninvasive markers of NASH-related disease. And, ultimately, we see unprecedented antifibrotic activity at week 12 with both the 1 mg and 3 mg dose,” Stephen A. Harrison, MD, of University of Oxford, said during his presentation. Read more