NASH update: 5 reports on trials, meetings, upcoming collaborations

The beginning of 2019 has already seen several significant advancements for the field of nonalcoholic steatohepatitis, from the inaugural NASH-TAG meeting to the recently announced positive results from the phase 3 study of Ocaliva.

Healio Gastroenterology and Liver Disease presents the following reports including trial results for Ocaliva (obeticholic acid, Intercept Pharma), a take-home report from NASH-TAG, and an update for this year’s International NASH Day.

Ocaliva shows fibrosis improvement in NASH

Intercept Pharmaceuticals announced that Ocaliva met its phase 3 study primary endpoint of fibrosis improvement by 1 stage or more with no worsening of nonalcoholic steatohepatitis, according to a press release and investor call.

“Fibrosis is currently the only NASH histology endpoint that predicts liver-related adverse clinical outcomes and all-cause mortality,” Mark Pruzanski, MD, president and CEO of Intercept, said during the investor call. “We believe today’s results represent a historic milestone in the development of novel treatments for patients with progressive fibrosis due to NASH, an indication for which there are no approved therapies.” Read more

Take Home from NASH-TAG: On the precipice of the fatty liver pipeline

Four years ago, as Vlad Ratziu, MD, and I spent some time together, we reflected on the emerging field of nonalcoholic steatohepatitis, realizing it was starting down the same path that hepatitis C forged just years prior. Looking around, we realized we needed a meeting much like HEP-DART, a meeting dedicated to the development of therapeutic agents for viral hepatitis, and we seized the opportunity to start NASH-TAG.

We developed this meeting to fill what we felt was a gap in the NASH landscape. There are a lot of meetings on fatty liver disease, but we wanted one that was very focused on therapeutic agent development, hence the TAG (Therapeutic AGent) acronym. Read more

Global Liver Institute to head second annual International NASH Day

The second annual International NASH Day — a public education campaign for nonalcoholic steatohepatitis — will be led this year by the Global Liver Institute and take place on June 12, according to a press release.

“Fatty liver disease and NASH are impending public health epidemics that have gone virtually unrecognized and untreated, leading to unnecessary patient and family suffering and death,” Donna Cryer, CEO of the Global Liver Institute, said in the release. “We are grateful that International NASH Day was started and feel confident that under the leadership of the global liver advocacy community this initiative will continue to grow into a high-profile, high-impact movement sustained by the public, policymakers, clinicians, researchers, and patients around the world.” Read more

Echosens, NASHNET collaborate for real-world NAFLD screening study

Echosens announced a pilot study in collaboration with the NASH Network designed to appropriately identify patients with progressive nonalcoholic fatty liver disease using FibroScan, according to a press release.

“An estimated 30% of individuals in the U.S. are affected by NAFLD, with most patients undiagnosed,” Douglas Dieterich, MD, director of the Institute for Liver Medicine at Mount Sinai Health System, said in the release. “Given this high prevalence of disease, cost-effective risk stratification strategies need to be proven and adopted to target more effective assessments and interventions for those patients at greater risk of advancing liver disease.” Read more

Gilead announces negative results from phase 3 trial for NASH fibrosis

Results from the STELLAR-4 phase 3 study showed that selonsertib did not meet the pre-specified 48-week endpoint of histologic improvement by 1 or more stage in fibrosis without worsening of nonalcoholic steatohepatitis, according to a press release.

“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments,” John McHutchison, AO, MD, chief scientific officer and head of research and development at Gilead, said in the release. “Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases.” Read more

The beginning of 2019 has already seen several significant advancements for the field of nonalcoholic steatohepatitis, from the inaugural NASH-TAG meeting to the recently announced positive results from the phase 3 study of Ocaliva.

Healio Gastroenterology and Liver Disease presents the following reports including trial results for Ocaliva (obeticholic acid, Intercept Pharma), a take-home report from NASH-TAG, and an update for this year’s International NASH Day.

Ocaliva shows fibrosis improvement in NASH

Intercept Pharmaceuticals announced that Ocaliva met its phase 3 study primary endpoint of fibrosis improvement by 1 stage or more with no worsening of nonalcoholic steatohepatitis, according to a press release and investor call.

“Fibrosis is currently the only NASH histology endpoint that predicts liver-related adverse clinical outcomes and all-cause mortality,” Mark Pruzanski, MD, president and CEO of Intercept, said during the investor call. “We believe today’s results represent a historic milestone in the development of novel treatments for patients with progressive fibrosis due to NASH, an indication for which there are no approved therapies.” Read more

Take Home from NASH-TAG: On the precipice of the fatty liver pipeline

Four years ago, as Vlad Ratziu, MD, and I spent some time together, we reflected on the emerging field of nonalcoholic steatohepatitis, realizing it was starting down the same path that hepatitis C forged just years prior. Looking around, we realized we needed a meeting much like HEP-DART, a meeting dedicated to the development of therapeutic agents for viral hepatitis, and we seized the opportunity to start NASH-TAG.

We developed this meeting to fill what we felt was a gap in the NASH landscape. There are a lot of meetings on fatty liver disease, but we wanted one that was very focused on therapeutic agent development, hence the TAG (Therapeutic AGent) acronym. Read more

Global Liver Institute to head second annual International NASH Day

The second annual International NASH Day — a public education campaign for nonalcoholic steatohepatitis — will be led this year by the Global Liver Institute and take place on June 12, according to a press release.

“Fatty liver disease and NASH are impending public health epidemics that have gone virtually unrecognized and untreated, leading to unnecessary patient and family suffering and death,” Donna Cryer, CEO of the Global Liver Institute, said in the release. “We are grateful that International NASH Day was started and feel confident that under the leadership of the global liver advocacy community this initiative will continue to grow into a high-profile, high-impact movement sustained by the public, policymakers, clinicians, researchers, and patients around the world.” Read more

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Echosens, NASHNET collaborate for real-world NAFLD screening study

Echosens announced a pilot study in collaboration with the NASH Network designed to appropriately identify patients with progressive nonalcoholic fatty liver disease using FibroScan, according to a press release.

“An estimated 30% of individuals in the U.S. are affected by NAFLD, with most patients undiagnosed,” Douglas Dieterich, MD, director of the Institute for Liver Medicine at Mount Sinai Health System, said in the release. “Given this high prevalence of disease, cost-effective risk stratification strategies need to be proven and adopted to target more effective assessments and interventions for those patients at greater risk of advancing liver disease.” Read more

Gilead announces negative results from phase 3 trial for NASH fibrosis

Results from the STELLAR-4 phase 3 study showed that selonsertib did not meet the pre-specified 48-week endpoint of histologic improvement by 1 or more stage in fibrosis without worsening of nonalcoholic steatohepatitis, according to a press release.

“While we are disappointed that the STELLAR-4 study did not achieve its primary endpoint, we remain committed to advancing therapies for patients with advanced fibrosis due to NASH, where there is a significant unmet need for effective and well-tolerated treatments,” John McHutchison, AO, MD, chief scientific officer and head of research and development at Gilead, said in the release. “Gilead has a long-term commitment and proven track record of addressing significant challenges in the field of liver diseases.” Read more

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