89bio presented new Phase 2b trial data on pegozafermin for treating advanced MASH, highlighting potential benefits in fibrosis reversal.
Quiver AI Summary
89bio, Inc. announced new analyses from its Phase 2b ENLIVEN trial of pegozafermin, aimed at treating metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis. The findings, presented at The Liver Meeting in San Diego, suggest pegozafermin's effectiveness in reversing fibrosis and preventing progression to cirrhosis. Chief Medical Officer Hank Mansbach expressed excitement over the results, while Dr. Naim Alkhouri emphasized the potential of non-invasive tests to identify high-risk patients. The trial showed positive outcomes in fibrosis improvement and MASH resolution, with pegozafermin demonstrating a favorable safety profile. The company is advancing into Phase 3 trials for both cirrhotic and non-cirrhotic patients, building on the promising results of the ENLIVEN study.
Potential Positives
- Presentation of new analyses from the Phase 2b ENLIVEN trial at a major medical conference highlights the company's ongoing research and commitment to addressing liver diseases.
- Positive data may enhance investor confidence and support the progression of pegozafermin through clinical trials, potentially leading to further development milestones.
- Pegozafermin's designation as a Breakthrough Therapy by the FDA and Priority Medicines status by the EMA underscores its significant therapeutic potential in treating MASH, attracting attention and credibility to 89bio's pipeline.
Potential Negatives
- Potential overreliance on post-hoc analyses from the Phase 2b ENLIVEN trial, which may not be as robust as primary clinical trial results.
- Risks and uncertainties are highlighted in the forward-looking statements, indicating potential challenges with future trial outcomes and regulatory approvals.
- Possible dependence on a single product candidate (pegozafermin), leading to increased vulnerability if it fails to receive expected approvals or positive results from ongoing trials.
FAQ
What is the ENLIVEN trial about?
The ENLIVEN trial is a Phase 2b study evaluating the safety and efficacy of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH).
What are the key findings from the recent analyses?
The analyses indicated pegozafermin's effectiveness in reversing fibrosis and preventing cirrhosis in advanced MASH patients.
What is pegozafermin?
Pegozafermin is a glycoPEGylated analog of FGF21, developed for treating metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG).
How was the trial designed?
The trial was a multicenter, randomized, double-blind study involving 192 patients dosed with varying amounts of pegozafermin or placebo.
What does "Breakthrough Therapy" designation mean?
The "Breakthrough Therapy" designation from the FDA indicates pegozafermin shows significant potential to treat serious conditions like MASH with fibrosis.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ETNB Insider Trading Activity
$ETNB insiders have traded $ETNB stock on the open market 1 times in the past 6 months. Of those trades, 0 have been purchases and 1 have been sales.
Here's a breakdown of recent trading of $ETNB stock by insiders over the last 6 months:
- QUOC LE-NGUYEN (See Remarks) sold 27,955 shares.
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
$ETNB Hedge Fund Activity
We have seen 84 institutional investors add shares of $ETNB stock to their portfolio, and 72 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- BVF INC/IL added 3,521,125 shares (+87.0%) to their portfolio in Q2 2024
- HOLOCENE ADVISORS, LP removed 3,450,689 shares (-100.0%) from their portfolio in Q2 2024
- SUVRETTA CAPITAL MANAGEMENT, LLC added 1,733,841 shares (+27.5%) to their portfolio in Q2 2024
- RA CAPITAL MANAGEMENT, L.P. added 1,408,450 shares (+11.0%) to their portfolio in Q2 2024
- MPM BIOIMPACT LLC removed 791,736 shares (-70.6%) from their portfolio in Q3 2024
- ORCHARD CAPITAL MANAGEMENT, LLC removed 697,334 shares (-94.3%) from their portfolio in Q3 2024
- WESTFIELD CAPITAL MANAGEMENT CO LP added 686,673 shares (+29.6%) to their portfolio in Q3 2024
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
SAN FRANCISCO, Nov. 15, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, announced new analyses of data from the Phase 2b ENLIVEN trial evaluating pegozafermin in metabolic dysfunction-associated steatohepatitis (MASH) patients with advanced fibrosis. The findings were presented in four poster sessions at The American Association for the Study of Liver Diseases (AASLD) The Liver Meeting
being held in San Diego, California.
"We are excited to present additional analyses from our Phase 2b ENLIVEN trial at this year's Liver Meeting, which reinforce pegozafermin's potential effectiveness in reversing fibrosis and preventing progression to cirrhosis in patients with advanced MASH," said Hank Mansbach, Chief Medical Officer of 89bio. "These analyses strengthen our confidence in the design of our Phase 3 trials for both cirrhotic and non-cirrhotic MASH, and we look forward to building on this momentum as we advance these trials."
"MASH is often underdiagnosed and undertreated, which can lead to cirrhosis and severe complications like the need for liver transplantation," said Naim Alkhouri, MD, Chief Medical Officer, Chief of Transplant Hepatology, and Director of the Fatty Liver Program at Arizona Liver Health (ALH). "These post-hoc analyses demonstrate the potential of NITs like FAST and AGILE3+ to identify high-risk patients more conveniently, potentially reducing the need for liver biopsy. The results show that pegozafermin not only improved patients' FAST scores but also achieved both MASH resolution and fibrosis improvement, indicating its potential as a treatment option for patients with advanced MASH."
Publications Presented at the Meeting:
Pegozafermin reduced progression to cirrhosis: A post-hoc analysis from the Phase 2b ENLIVEN study (Publication 1563).
Biomarker response in metabolic dysfunction-associated steatohepatitis (MASH) patients with high-risk baseline FAST scores: Observations from the ENLIVEN Phase 2b trial with pegozafermin (Publication 1549).
Diagnostic potential of FAST and AGILE3+ scores for F2/F3 fibrosis: An analysis of the Phase 2 ENLIVEN study (Publication 2014).
Analysis and integration of machine learning for biomarker assessments and their association with treatment response: Insights from the ENLIVEN Phase 2b trial of pegozafermin (Publication 2008)
A copy of the AASLD posters will be accessible under "Scientific Publications" in the pipeline section of
89bio's website
.
About ENLIVEN
ENLIVEN was a multicenter, randomized, double-blind, placebo-controlled Phase 2b trial designed to evaluate the safety and efficacy of weekly or every-two-week dosing of pegozafermin for the treatment of patients with biopsy confirmed MASH and NAS ≥ 4 for 48 weeks. In the trial, 192 patients were dosed with pegozafermin 15mg QW, 30mg QW and 44mg Q2W, or placebo. Primary outcomes measured were proportion of participants with resolution of MASH without worsening of fibrosis and proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of MASH at week 24. Secondary measures included change from baseline in liver fat, liver enzymes, noninvasive markers of liver fibrosis, glycemic control, lipoproteins, and body weight as well as safety and tolerability measures. Patients who entered the blinded extension phase were subsequently treated for an additional 24 weeks for a total treatment period of 48 weeks. Some patients who were on placebo (n=19) were re-randomized to receive pegozafermin in the extension phase. Key endpoints in the extension phase include liver fat and noninvasive markers of liver fibrosis and inflammation. ENLIVEN achieved high statistical significance on primary histology endpoints with 30mg QW and 44mg Q2W dosing at week 24 and the results were published in the New England Journal of Medicine. To learn more about the clinical trial, visit clinicaltrials.gov: NCT04929483.
About pegozafermin
Pegozafermin is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21) being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). FGF21 is an endogenous hormone that has broad effects such as regulating energy expenditure, glucose and lipid metabolism. In clinical trials, pegozafermin has demonstrated direct anti-fibrotic and anti-inflammatory effects on the liver, as well as reduced triglyceride levels, improved insulin resistance and glycemic control, and continued to demonstrate a favorable safety and tolerability profile. Pegozafermin received Breakthrough Therapy designation (BTD) status from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) status from the European Medicines Agency (EMA) for the treatment of MASH with fibrosis. Pegozafermin is being studied in the Phase 3 ENLIGHTEN trial program for MASH and the Phase 3 ENTRUST trial for SHTG.
About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. The company is focused on rapidly advancing its lead candidate, pegozafermin, through clinical development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit
or follow the company on
LinkedIn
.
Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, statements regarding the therapeutic potential and utility, efficacy and clinical benefits of pegozafermin, the safety and tolerability profile of pegozafermin and trial designs, clinical development plans and timing for pegozafermin, including confirming the long-term efficacy, tolerability and sustained improvement in key liver health markers observed in the Phase 2b ENLIVEN trial evaluating pegozafermin in the current Phase 3 trials for both cirrhotic and non-cirrhotic MASH. Words such as "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "design," "estimate," "predict," "potential," "anticipate," "goal," "opportunity," "develop," "plan" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While 89bio believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in 89bio's filings with the Securities and Exchange Commission (SEC)), many of which are beyond 89bio's control and subject to change. Actual results could be materially different. Risks and uncertainties include: expectations regarding the design of the ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis trials; expectations regarding the timing and outcome of the ENTRUST Phase 3 trial in SHTG; 89bio's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; receipt of BTD for pegozafermin in MASH may not result in a faster development process, review or approval compared to drugs considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA; 89bio's substantial dependence on the success of its lead product candidate; competition from competing products; the impact of general economic, health, industrial or political conditions in the United States or internationally; the sufficiency of 89bio's capital resources and its ability to raise additional capital; and other risks and uncertainties identified in 89bio's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and other subsequent disclosure documents filed with the SEC. 89bio claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. 89bio expressly disclaims any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law.
Investor Contacts:
Annie Chang
89bio, Inc.
investors@89bio.com
PJ Kelleher
LifeSci Advisors, LLC
+1-617-430-7579
pkelleher@lifesciadvisors.com
Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com