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Pfizer (PFE) Gets Fast Track Designation for NASH Therapy
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Pfizer (PFE - Free Report) recently announced that the FDA has granted Fast Track designation to its investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.
The investigational therapy comprises ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).
The designation from the regulatory body facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address the unmet medical need.
NASH is a serious, progressive form of non-alcoholic fatty liver disease (NAFLD) caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver.
The combination under investigation — diacylglycerol O-acyltransferase 2 (DGAT2) and ACC — are two key enzymes that regulate lipid metabolism. Inhibitors of ACC and DGAT2 have demonstrated the ability to lower liver fat in patients with NAFLD. Hence, Pfizer expects the combination to lead to direct improvements in inflammation and fibrosis.
Pfizer is currently evaluating the combination in an ongoing mid-stage study. The study is evaluating the impact of treatment on the resolution of NASH or improvement in liver fibrosis and is expected to complete in 2024. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential phase III development program.
Pfizer’s stock is down 8.5% this year so far against an increase of 5.8% for the industry.
Image Source: Zacks Investment Research
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same.
Intercept Pharmaceuticals is evaluating obeticholic acid for NASH. The company, however, suffered a setback when the FDA issued a complete response letter (CRL) for obeticholic acid as it was a frontrunner in receiving a potential approval for the treatment of NASH.
ICPT focuses on delivering new interim data analyses from its phase III REGENERATE study in patients with advanced fibrosis due to NASH later this quarter. Intercept is also planning a pre-submission meeting with FDA in June.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VK2809 is currently being evaluated in a phase IIb study in patients with NASH. Viking expects to complete enrollment in the second half of 2022.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
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Pfizer (PFE) Gets Fast Track Designation for NASH Therapy
Pfizer (PFE - Free Report) recently announced that the FDA has granted Fast Track designation to its investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.
The investigational therapy comprises ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi).
The designation from the regulatory body facilitates the development and expedites the review of new drugs and vaccines intended to treat or prevent serious conditions and address the unmet medical need.
NASH is a serious, progressive form of non-alcoholic fatty liver disease (NAFLD) caused by a buildup of fat in the liver and accompanied by inflammation, liver cell damage, and in some cases, scarring of the liver.
The combination under investigation — diacylglycerol O-acyltransferase 2 (DGAT2) and ACC — are two key enzymes that regulate lipid metabolism. Inhibitors of ACC and DGAT2 have demonstrated the ability to lower liver fat in patients with NAFLD. Hence, Pfizer expects the combination to lead to direct improvements in inflammation and fibrosis.
Pfizer is currently evaluating the combination in an ongoing mid-stage study. The study is evaluating the impact of treatment on the resolution of NASH or improvement in liver fibrosis and is expected to complete in 2024. The results of this study, which also includes arms investigating ervogastat as monotherapy, will inform a potential phase III development program.
Pfizer’s stock is down 8.5% this year so far against an increase of 5.8% for the industry.
Image Source: Zacks Investment Research
While the NASH market promises potential with no approved therapies yet, it is challenging.
Quite a few players are trying their hand at successfully developing a treatment for the same.
Intercept Pharmaceuticals is evaluating obeticholic acid for NASH. The company, however, suffered a setback when the FDA issued a complete response letter (CRL) for obeticholic acid as it was a frontrunner in receiving a potential approval for the treatment of NASH.
ICPT focuses on delivering new interim data analyses from its phase III REGENERATE study in patients with advanced fibrosis due to NASH later this quarter. Intercept is also planning a pre-submission meeting with FDA in June.
Another company, Viking Therapeutics (VKTX - Free Report) , is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. VK2809 is currently being evaluated in a phase IIb study in patients with NASH. Viking expects to complete enrollment in the second half of 2022.
Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare space is Alkermes (ALKS - Free Report) , which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.