89bio Presents New Analyses Evaluating Pegozafermin and Potential Benefit of Non-Invasive Tests from the ENLIVEN Phase 2b Trial in MASH Patients at AASLD The Liver Meeting® 2024
89bio presented new analyses from the Phase 2b ENLIVEN trial evaluating pegozafermin in MASH patients with advanced fibrosis at The Liver Meeting® 2024. The post-hoc analyses demonstrate pegozafermin's potential anti-fibrotic effects and the utility of non-invasive tests (NITs) in correlating with histological endpoints. The data, presented in four poster sessions, showed that pegozafermin improved FAST scores and achieved both MASH resolution and fibrosis improvement, suggesting its effectiveness in preventing progression to cirrhosis in advanced MASH patients. The findings support the design of upcoming Phase 3 trials for both cirrhotic and non-cirrhotic MASH.
89bio ha presentato nuove analisi del trial di Fase 2b ENLIVEN che valuta pegozafermin in pazienti con MASH e fibrosi avanzata al The Liver Meeting® 2024. Le analisi post-hoc dimostrano il potenziale effetto anti-fibrotico di pegozafermin e l'utilità dei test non invasivi (NITs) nella correlazione con i risultati istologici. I dati, presentati in quattro sessioni di poster, hanno mostrato che pegozafermin ha migliorato i punteggi FAST e ha raggiunto sia la risoluzione della MASH che il miglioramento della fibrosi, suggerendo la sua efficacia nel prevenire la progressione verso la cirrosi nei pazienti con MASH avanzata. I risultati supportano la progettazione dei prossimi trial di Fase 3 sia per pazienti cirrotici che non cirrotici con MASH.
89bio presentó nuevos análisis del ensayo de Fase 2b ENLIVEN que evalúa pegozafermin en pacientes con MASH y fibrosis avanzada en The Liver Meeting® 2024. Los análisis post-hoc demuestran el potencial efecto antifibrótico de pegozafermin y la utilidad de las pruebas no invasivas (NITs) en la correlación con los resultados histológicos. Los datos, presentados en cuatro sesiones de póster, mostraron que pegozafermin mejoró los puntajes FAST y logró tanto la resolución de MASH como la mejora de la fibrosis, sugiriendo su efectividad en la prevención de la progresión a cirrosis en pacientes con MASH avanzada. Los hallazgos apoyan el diseño de los próximos ensayos de Fase 3 tanto para pacientes cirróticos como no cirróticos con MASH.
89bio는 The Liver Meeting® 2024에서 MASH 환자의 진행된 섬유증과 관련하여 pegozafermin을 평가한 2b상 ENLIVEN 시험의 새로운 분석 결과를 발표했습니다. 사후 분석 결과는 pegozafermin의 잠재적인 항 섬유화 효과와 조직학적 최종 결과와의 상관 관계에 대한 비침습적 검사(NIT)의 유용성을 보여줍니다. 네 개의 포스터 세션에서 발표된 데이터는 pegozafermin이 FAST 점수를 개선하고 MASH 해결 및 섬유증 개선을 달성했으며, 이는 진행된 MASH 환자에서 간경화로의 진행을 예방하는 데 효과적임을 시사합니다. 이 발견은 진행된 MASH 환자에 대한 간경화 및 비간경화 환자 모두를 위한 향후 3상 시험의 설계를 지지합니다.
89bio a présenté de nouvelles analyses de l'essai de Phase 2b ENLIVEN évaluant pegozafermin chez des patients atteints de MASH avec fibrose avancée lors du The Liver Meeting® 2024. Les analyses post-hoc démontrent le potentiel effet anti-fibrotique de pegozafermin et l'utilité des tests non-invasifs (NIT) dans la corrélation avec les résultats histologiques. Les données, présentées lors de quatre sessions d'affichage, ont montré que pegozafermin améliorait les scores FAST et atteignait à la fois la résolution de la MASH et l'amélioration de la fibrose, suggérant son efficacité à prévenir la progression vers la cirrhose chez les patients atteints de MASH avancée. Les résultats soutiennent la conception des futurs essais de Phase 3 tant pour les patients cirrhotiques que non cirrhotiques atteints de MASH.
89bio präsentierte neue Analysen aus der Phase-2b-Studie ENLIVEN, die pegozafermin bei MASH-Patienten mit fortgeschrittener Fibrose auf dem The Liver Meeting® 2024 auswertet. Die post-hoc Analysen zeigen das potenzielle anti-fibrotische Effekt von pegozafermin und die Nützlichkeit nicht-invasiver Tests (NITs) zur Korrelation mit histologischen Endpunkten. Die in vier Poster-Sitzungen präsentierten Daten zeigten, dass pegozafermin die FAST-Werte verbesserte und sowohl eine MASH-Resolution als auch eine Verbesserung der Fibrose erreichte, was auf seine Wirksamkeit zur Verhinderung der Progression zur Zirrhose bei fortgeschrittenen MASH-Patienten hinweist. Die Ergebnisse unterstützen das Design der bevorstehenden Phase-3-Studien sowohl für zirrhosische als auch nicht-zirrhosische MASH.
- Post-hoc analyses showed pegozafermin's effectiveness in reversing fibrosis
- Data demonstrated prevention of progression to cirrhosis in advanced MASH patients
- Treatment achieved both MASH resolution and fibrosis improvement
- None.
Insights
The new post-hoc analyses from the ENLIVEN Phase 2b trial provide compelling evidence for pegozafermin's therapeutic potential in MASH patients. Key findings demonstrate the drug's ability to prevent progression to cirrhosis and improve fibrosis, which are critical outcomes for patients with advanced liver disease. The validation of non-invasive tests (NITs) like FAST and AGILE3+ scores represents a significant advancement in patient care, potentially reducing reliance on invasive liver biopsies.
The machine learning integration for biomarker assessment strengthens the scientific rigor of the findings. These results are particularly significant for the upcoming Phase 3 trials, as they provide robust support for the trial design and patient selection criteria. The correlation between NITs and histological endpoints could streamline future patient monitoring and treatment response assessment, potentially accelerating the path to market.
New post-hoc analyses reinforce pegozafermin’s potential anti-fibrotic effects and the potential utility of non-invasive tests which correlate to histological endpoints
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 www.89bio.com 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
FAQ
What were the key findings of 89bio's ENLIVEN Phase 2b trial presentations at AASLD 2024?
How did pegozafermin perform in treating MASH patients in the ENLIVEN trial (ETNB)?
What role did non-invasive tests play in 89bio's ENLIVEN trial analysis?
