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Intercept (ICPT) Down Ahead of GIDAC Meeting for NASH Treatment
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Shares of Intercept Pharmaceuticals were down 14.7% after the FDA publicly posted briefing documents in advance of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to review the information that supports the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
The meeting is scheduled for May 19, 2023.
The stock was probably down due to concerns about drug-induced liver injury. The document stated that, during the review, the FDA identified modest benefits and serious risks of OCA for treating NASH. The key issues for consideration in the benefit-risk assessment of OCA for NASH with fibrosis include the theoretical clinical benefits of a one-stage improvement in fibrosis, along with the risks of drug-induced liver injury, gallstone or bile duct stone/sludge and related complications, new-onset or worsening dyslipidemia, accelerating progression to developing prediabetes or diabetes and worsening of glycemic control in diabetic subjects.
The outcome of the meeting will provide insights to the FDA, which is scheduled to make a decision regarding the same on Jun 22, 2023. Investors are skeptical, as Intercept previously faced roadblocks in getting its NDA accepted.
In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its NDA for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that the FDA had determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for treating patients with liver fibrosis due to NASH. This analysis was based on the data reviewed by the agency. The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue.
Thereafter, in January 2023, the FDA accepted the NDA, indicating its consideration of this as a complete Class 2 resubmission and assigned a target action date of Jun 22, 2023.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Nevertheless, shares have gained 11.8% in the year so far against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
OCA is already approved under the brand name Ocaliva for treating primary biliary cholangitis (in combination with ursodeoxycholic acid [UDCA]) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
While the NASH market promises potential with no approved therapies, it is challenging as well.
Several players are attempting to develop a treatment for the same condition.
Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) announced that its pipeline candidate resmetirom received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES.
Shares of Viking Therapeutics (VKTX - Free Report) gained recently after the company announced positive top-line results from its phase IIb clinical study of VK2809 in patients with biopsy-confirmed NASH. The study achieved its primary endpoint with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 compared with placebo. VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins compared with placebo.
The majority (94%) of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. Viking Therapeutics plans to report 52-week biopsy data from the VOYAGE study in the first half of next year.
Image: Bigstock
Intercept (ICPT) Down Ahead of GIDAC Meeting for NASH Treatment
Shares of Intercept Pharmaceuticals were down 14.7% after the FDA publicly posted briefing documents in advance of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting to review the information that supports the company’s new drug application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).
The meeting is scheduled for May 19, 2023.
The stock was probably down due to concerns about drug-induced liver injury. The document stated that, during the review, the FDA identified modest benefits and serious risks of OCA for treating NASH. The key issues for consideration in the benefit-risk assessment of OCA for NASH with fibrosis include the theoretical clinical benefits of a one-stage improvement in fibrosis, along with the risks of drug-induced liver injury, gallstone or bile duct stone/sludge and related complications, new-onset or worsening dyslipidemia, accelerating progression to developing prediabetes or diabetes and worsening of glycemic control in diabetic subjects.
The outcome of the meeting will provide insights to the FDA, which is scheduled to make a decision regarding the same on Jun 22, 2023. Investors are skeptical, as Intercept previously faced roadblocks in getting its NDA accepted.
In June 2020, Intercept received a complete response letter (“CRL”) from the FDA stating that its NDA for OCA for the treatment of liver fibrosis due to NASH could not be approved in its present form. The CRL indicated that the FDA had determined that the predicted benefit of OCA, based on a surrogate histopathologic endpoint, remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for treating patients with liver fibrosis due to NASH. This analysis was based on the data reviewed by the agency. The FDA then recommended that Intercept submit additional post-interim analysis efficacy and safety data from the ongoing REGENERATE study in support of potential accelerated approval and that the long-term outcomes phase of the trial should continue.
Thereafter, in January 2023, the FDA accepted the NDA, indicating its consideration of this as a complete Class 2 resubmission and assigned a target action date of Jun 22, 2023.
NASH is a serious progressive liver disease caused by excessive fat accumulation in the liver that induces chronic inflammation, resulting in progressive fibrosis (scarring) that can lead to cirrhosis, eventual liver failure, cancer and death.
Nevertheless, shares have gained 11.8% in the year so far against the industry’s 7.2% decline.
Image Source: Zacks Investment Research
OCA is already approved under the brand name Ocaliva for treating primary biliary cholangitis (in combination with ursodeoxycholic acid [UDCA]) in adults with an inadequate response to UDCA alone or as a monotherapy for adults intolerant to UDCA.
While the NASH market promises potential with no approved therapies, it is challenging as well.
Several players are attempting to develop a treatment for the same condition.
Madrigal Pharmaceuticals, Inc. (MDGL - Free Report) announced that its pipeline candidate resmetirom received Breakthrough Therapy designation from the FDA for the treatment of patients with NASH with liver fibrosis. Madrigal is currently conducting four phase III clinical studies to demonstrate the safety and efficacy of resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE and MAESTRO-NASH-OUTCOMES.
Shares of Viking Therapeutics (VKTX - Free Report) gained recently after the company announced positive top-line results from its phase IIb clinical study of VK2809 in patients with biopsy-confirmed NASH. The study achieved its primary endpoint with patients receiving VK2809 experiencing statistically significant reductions in liver fat content from baseline to week 12 compared with placebo. VK2809-treated patients demonstrated statistically significant reductions in low-density lipoprotein cholesterol, triglycerides and atherogenic lipoproteins compared with placebo.
The majority (94%) of treatment-related adverse events among patients receiving VK2809 were reported as mild or moderate. Viking Therapeutics plans to report 52-week biopsy data from the VOYAGE study in the first half of next year.
Currently, Intercept has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.