89bio (ETNB) Up 25% on Upbeat Data From Mid-Stage NASH Study
Shares of 89bio ETNB were up 25.2% on Mar 22 after management reported positive data from the phase IIb ENLIVEN study which is evaluating its lead candidate, pegozafermin, in patients with nonalcoholic steatohepatitis (NASH).
The ENLIVEN study met both the primary histology endpoints with high statistical significance. To advance the development of a drug in NASH indication, the FDA issued guidance stating that a study must achieve at least one of the two endpoints. Either the drug must improve fibrosis by one stage while patients show no worsening of NASH symptoms, or it must completely resolve NASH symptoms but not lead to a worsening of fibrosis.
Data from the study showed that treatment with pegozafermin achieved both endpoints at two different dose levels — 44mg every two week (Q2W) and 30mg weekly (QW) doses. Treatment with pegozafermin showed at least one-stage fibrosis improvement without worsening of NASH at 3.5 times the placebo rate and NASH resolution without worsening of fibrosis between 12-14 times the placebo rate.
27% and 26% of participants who were dosed in the 44mg Q2W and 30mg QW groups, respectively, showed at least one-stage fibrosis improvement without worsening of NASH, compared to 7% of participants in the placebo group. Meanwhile, 26% and 23% of participants dosed in the 44mg Q2W and 30mg QW groups, respectively, showed at least one-stage fibrosis improvement without worsening of NASH, compared to 2% of participants in the placebo group.
Based on the above results, 89bio intends to advance pegozafermin in phase III development.
In the year so far, shares of 89bio have risen 7.5% against the industry’s fall of 7.5%.
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NASH is a progressive form of non-alcoholic fatty liver disease characterized by excessive fat buildup in the liver, accompanied by inflammation and fibrosis, which may progress to cirrhosis, liver failure, cancer and death.
Apart from NASH, management is also evaluating pegozafermin in severe hypertriglyceridemia (SHTG) indication. In this regard, 89bio intends to start a late-stage study in second-quarter 2023 following positive FDA feedback.
While the NASH market holds potential with no approved therapies yet, it is challenging as several companies are trying to develop a successful treatment for the same.
Last December, Madrigal Pharmaceuticals MDGL reported positive top-line data from the pivotal phase III MAESTRO-NASH study evaluating its lead candidate resmetirom for treating NASH and liver fibrosis.
Data from the 52-week serial liver biopsy phase III study showed that patients treated with both daily oral doses of Madrigal’s resmetirom (80 mg and 100 mg) achieved both primary endpoints and potentially clinically meaningful effects as compared to placebo. The MAESTRO-NASH study achieved both liver histological improvement endpoints as proposed by the FDA, which is likely to predict clinical benefit to support accelerated approval of Madrigal’s resmetirom for the treatment of NASH with liver fibrosis.
Based on this data, Madrigal will file initiate a new drug application (NDA) filing for resmetirom in NASH indication by first-half 2023.
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Zacks Rank & Stocks to Consider
89bio currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Atara Biotherapeutics ATRA and AVITA Medical RCEL, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Atara Biotherapeutics’ 2023 loss per share have narrowed from $2.28 to $2.17. During the same period, the loss per share estimates for 2024 narrowed from $1.81 to $1.62. Shares of Atara Biotherapeutics have declined 12.5% in the year-to-date period.
Earnings of Atara Biotherapeutics beat estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing an earnings surprise of 13.50%, on average. In the last reported quarter, Atara Biotherapeutics’ earnings missed estimates by 18.03%.
In the past 30 days, estimates for AVITA Medical’s 2023 loss per share narrowed from $1.26 to 99 cents. During the same period, the loss per share estimates for 2024 narrowed from 92 cents to 79 cents. In the year so far, shares of AVITA Medical have surged 100.9%.
Earnings of AVITA Medical beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 22.16%, on average. In the last reported quarter, AVITA Medical’s earnings beat estimates by 34.38%.
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