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Gilead (GILD), Novo Nordisk Post Upbeat Data From NASH Study
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Gilead Sciences, Inc. (GILD - Free Report) and partner Novo Nordisk A/S (NVO - Free Report) announced positive results from a phase II proof-of-concept study at The Liver Meeting Digital Experience.
The five-arm study evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocost over 24 weeks in 108 patients with non-alcoholic steatohepatitis (NASH).
Both companies had collaborated in 2019 for evaluating combination treatments to treat NASH.
The study showed that all regimens were well tolerated in NASH patients and those with mild-to-moderate fibrosis. As a result, the study met its primary endpoint. The most common adverse events (AEs) were gastrointestinal. In addition, minimal pruritus (itching) was observed in people treated with cilofexor. However, 5-14% of patients discontinued any trial treatment due to AEs.
Meanwhile, exploratory efficacy endpoints assessing biomarkers of liver health at the 24th week in post-hoc analyses showed statistically significant improvements in hepatic steatosis and liver injury in the combination arms compared to only semaglutide. Although liver stiffness measured by vibration-controlled transient elastography (VCTE) and enhanced liver fibrosis (ELF) score declined in all groups, statistically significant differences among groups were not observed.
Both companies also presented preclinical data supporting the development of combination approaches to NASH. Semaglutide alone and in combination with cilofexor and/or GS-834356 (an analog of firsocostat) were administered daily for 12 weeks to a murine model of diet-induced NASH (n=15-16/group). The results from this preclinical study demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction.
We note that semaglutide is approved for the treatment of type 2 diabetes under the brand name Rybelsus.
While the NASH market promises potential, it is quite challenging as well. Quite a few companies are developing treatments for NASH, sparking competition in the space.
Notably, Intercept Pharmaceuticals is developing obeticholic acid for the treatment of fibrosis due to NASH while clinical-stage biopharmaceutical company Galmed Pharmaceuticals Ltd. (GLMD - Free Report) is developing Aramchol for patients with NASH and fibrosis.
The stock has lost 5.9% in the year so far against the industry's growth of 0.5%.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
Image: Bigstock
Gilead (GILD), Novo Nordisk Post Upbeat Data From NASH Study
Gilead Sciences, Inc. (GILD - Free Report) and partner Novo Nordisk A/S (NVO - Free Report) announced positive results from a phase II proof-of-concept study at The Liver Meeting Digital Experience.
The five-arm study evaluated combinations of Novo Nordisk’s semaglutide, a GLP-1 receptor agonist, with Gilead’s investigational FXR agonist cilofexor and/or Gilead’s investigational ACC inhibitor firsocost over 24 weeks in 108 patients with non-alcoholic steatohepatitis (NASH).
Both companies had collaborated in 2019 for evaluating combination treatments to treat NASH.
The study showed that all regimens were well tolerated in NASH patients and those with mild-to-moderate fibrosis. As a result, the study met its primary endpoint. The most common adverse events (AEs) were gastrointestinal. In addition, minimal pruritus (itching) was observed in people treated with cilofexor. However, 5-14% of patients discontinued any trial treatment due to AEs.
Meanwhile, exploratory efficacy endpoints assessing biomarkers of liver health at the 24th week in post-hoc analyses showed statistically significant improvements in hepatic steatosis and liver injury in the combination arms compared to only semaglutide. Although liver stiffness measured by vibration-controlled transient elastography (VCTE) and enhanced liver fibrosis (ELF) score declined in all groups, statistically significant differences among groups were not observed.
Both companies also presented preclinical data supporting the development of combination approaches to NASH. Semaglutide alone and in combination with cilofexor and/or GS-834356 (an analog of firsocostat) were administered daily for 12 weeks to a murine model of diet-induced NASH (n=15-16/group). The results from this preclinical study demonstrated that while semaglutide significantly improved NASH and fibrosis-related endpoints, the addition of either cilofexor or the firsocostat analog further improved liver fat reduction.
We note that semaglutide is approved for the treatment of type 2 diabetes under the brand name Rybelsus.
While the NASH market promises potential, it is quite challenging as well. Quite a few companies are developing treatments for NASH, sparking competition in the space.
Notably, Intercept Pharmaceuticals is developing obeticholic acid for the treatment of fibrosis due to NASH while clinical-stage biopharmaceutical company Galmed Pharmaceuticals Ltd. (GLMD - Free Report) is developing Aramchol for patients with NASH and fibrosis.
The stock has lost 5.9% in the year so far against the industry's growth of 0.5%.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>