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Akero (AKRO) Slumps 63% on Mixed Results From NASH Study
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Shares of Akero Therapeutics (AKRO - Free Report) plummeted 62.6% on Oct 10 after it announced data from the ongoing phase IIb SYMMETRY study on its lead candidate efruxifermin (“EFX”) in patients with compensated cirrhosis (F4) due to non-alcoholic steatohepatitis (“NASH”).
The SYMMETRY study did not achieve statistical significance in its primary endpoint of at least a one-stage improvement in liver fibrosis without the worsening of NASH, following 36 weeks of treatment with EFX compared with placebo. The study evaluated two doses of EFX — one at a lower dose of 28mg and another at a higher dose of 50 mg.
Data from the study showed that 22% of patients receiving a lower dose of EFX and 24% of patients receiving a higher EFX dose experienced at least a one-stage improvement in liver fibrosis with no worsening of NASH. However, this improvement wasn't statistically significant compared to the 14% in the placebo-treated group.
However, the SYMMETRY study did achieve statistical significance in one of its secondary endpoints of NASH resolution with no worsening of fibrosis. More than half of the patients receiving EFX – 63% in the lower dose group and 60% in the higher dose group – experienced NASH resolution, compared to 26% of patients on placebo.
Statistically significant improvements were also observed for EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins. In addition, 4% of patients in each dose group also showed a two-stage or three-stage improvement in fibrosis without worsening of NASH.
Despite the mixed results, shares fell significantly, likely due to the SYMMETRY study not being able to achieve its primary endpoint. The above results also wiped out investors' gains in the last year on positive data readouts from the company’s other clinical studies on EFX in NASH indication.
In the year so far, shares of Akero Therapeutics have plunged 66.9% against the industry’s 19.8% fall.
Image Source: Zacks Investment Research
Apart from cirrhotic NASH, Akero is evaluating EFX for pre-cirrhotic NASH (F2-F3 fibrosis) in the ongoing phase IIb HARMONY study. Last year, management reported that the HARMONY study met its primary and secondary endpoints.
Akero is also on track to initiate two phase III studies as part of the late-stage SYNCHRONY program in second-half 2023 to evaluate EFX for NASH indication. While one study will evaluate EFX in patients with biopsy confirmed pre-cirrhotic NASH, fibrosis stage 2 or 3 (F2-F3), another study will assess the drug in patients with non-invasively diagnosed NASH or non-alcoholic fatty liver disease (“NAFLD”).
NASH is a progressive form of NAFLD, characterized by excessive fat buildup in the liver, accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death. Currently, there are no approved therapies for NASH indication.
The SYMMETRY study results also dragged down its rival 89bio (ETNB - Free Report) , which plummeted 37.1% on Tuesday. Like Akero Therapeutics, 89bio is also evaluating its lead pipeline drug pegozafermin for NASH indication. Pegozafermin is based on a mechanism similar to EFX.
Last month, the FDA granted breakthrough therapy designation to the 89bio drug in NASH indication. 89bio intends to meet with the agency officials before 2023-end to seek regulatory feedback for late-stage clinical development of its lead drug in NASH indication.
Apart from Akero and 89bio, several companies like Madrigal Pharmaceuticals (MDGL - Free Report) and Viking Therapeutics (VKTX - Free Report) are also trying to develop a successful treatment.
Last month, the FDA accepted Madrigal Pharmaceuticals’ regulatory filing seeking approval for lead candidate resmetirom to treat NASH and liver fibrosis. The application has been granted priority review and a final decision is expected before March 2024-end. The potential approval and successful commercialization of resmetirom will be a massive boost for Madrigal. The market opportunity is substantially large, with no treatment currently approved to address this disease.
Viking Therapeutics is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Earlier this May, VKTX reported positive 12-week data from the ongoing phase IIb VOYAGE study, evaluating VK2809 in patients with biopsy-confirmed NASH. The study met its primary endpoint of a statistically significant reduction in liver fat content in NASH and significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic lipoproteins against placebo. Viking Therapeutics plans to report 52-week treatment data from the VOYAGE study in the first half of the following year.
Image: Bigstock
Akero (AKRO) Slumps 63% on Mixed Results From NASH Study
Shares of Akero Therapeutics (AKRO - Free Report) plummeted 62.6% on Oct 10 after it announced data from the ongoing phase IIb SYMMETRY study on its lead candidate efruxifermin (“EFX”) in patients with compensated cirrhosis (F4) due to non-alcoholic steatohepatitis (“NASH”).
The SYMMETRY study did not achieve statistical significance in its primary endpoint of at least a one-stage improvement in liver fibrosis without the worsening of NASH, following 36 weeks of treatment with EFX compared with placebo. The study evaluated two doses of EFX — one at a lower dose of 28mg and another at a higher dose of 50 mg.
Data from the study showed that 22% of patients receiving a lower dose of EFX and 24% of patients receiving a higher EFX dose experienced at least a one-stage improvement in liver fibrosis with no worsening of NASH. However, this improvement wasn't statistically significant compared to the 14% in the placebo-treated group.
However, the SYMMETRY study did achieve statistical significance in one of its secondary endpoints of NASH resolution with no worsening of fibrosis. More than half of the patients receiving EFX – 63% in the lower dose group and 60% in the higher dose group – experienced NASH resolution, compared to 26% of patients on placebo.
Statistically significant improvements were also observed for EFX groups in non-invasive markers of liver injury and fibrosis, insulin sensitization and lipoproteins. In addition, 4% of patients in each dose group also showed a two-stage or three-stage improvement in fibrosis without worsening of NASH.
Despite the mixed results, shares fell significantly, likely due to the SYMMETRY study not being able to achieve its primary endpoint. The above results also wiped out investors' gains in the last year on positive data readouts from the company’s other clinical studies on EFX in NASH indication.
In the year so far, shares of Akero Therapeutics have plunged 66.9% against the industry’s 19.8% fall.
Image Source: Zacks Investment Research
Apart from cirrhotic NASH, Akero is evaluating EFX for pre-cirrhotic NASH (F2-F3 fibrosis) in the ongoing phase IIb HARMONY study. Last year, management reported that the HARMONY study met its primary and secondary endpoints.
Akero is also on track to initiate two phase III studies as part of the late-stage SYNCHRONY program in second-half 2023 to evaluate EFX for NASH indication. While one study will evaluate EFX in patients with biopsy confirmed pre-cirrhotic NASH, fibrosis stage 2 or 3 (F2-F3), another study will assess the drug in patients with non-invasively diagnosed NASH or non-alcoholic fatty liver disease (“NAFLD”).
NASH is a progressive form of NAFLD, characterized by excessive fat buildup in the liver, accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death. Currently, there are no approved therapies for NASH indication.
The SYMMETRY study results also dragged down its rival 89bio (ETNB - Free Report) , which plummeted 37.1% on Tuesday. Like Akero Therapeutics, 89bio is also evaluating its lead pipeline drug pegozafermin for NASH indication. Pegozafermin is based on a mechanism similar to EFX.
Last month, the FDA granted breakthrough therapy designation to the 89bio drug in NASH indication. 89bio intends to meet with the agency officials before 2023-end to seek regulatory feedback for late-stage clinical development of its lead drug in NASH indication.
Apart from Akero and 89bio, several companies like Madrigal Pharmaceuticals (MDGL - Free Report) and Viking Therapeutics (VKTX - Free Report) are also trying to develop a successful treatment.
Last month, the FDA accepted Madrigal Pharmaceuticals’ regulatory filing seeking approval for lead candidate resmetirom to treat NASH and liver fibrosis. The application has been granted priority review and a final decision is expected before March 2024-end. The potential approval and successful commercialization of resmetirom will be a massive boost for Madrigal. The market opportunity is substantially large, with no treatment currently approved to address this disease.
Viking Therapeutics is developing a candidate, VK2809, for biopsy-confirmed NASH and fibrosis. Earlier this May, VKTX reported positive 12-week data from the ongoing phase IIb VOYAGE study, evaluating VK2809 in patients with biopsy-confirmed NASH. The study met its primary endpoint of a statistically significant reduction in liver fat content in NASH and significant reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides and atherogenic lipoproteins against placebo. Viking Therapeutics plans to report 52-week treatment data from the VOYAGE study in the first half of the following year.
Akero Therapeutics, Inc. Price
Akero Therapeutics, Inc. price | Akero Therapeutics, Inc. Quote
Zacks Rank
Akero Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.