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89bio, Inc. (Nasdaq: ETNB) is a clinical-stage biopharmaceutical company headquartered in San Francisco, California. Since its founding in 2018, 89bio has been committed to developing and commercializing innovative therapies for the treatment of liver and cardio-metabolic diseases, addressing critical unmet medical needs.
The company’s lead product candidate is pegozafermin (formerly BIO89-100), a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). Pegozafermin has shown promise in treating nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). This candidate targets metabolic dysfunction-associated steatohepatitis (MASH), which can lead to severe liver complications, including cirrhosis and liver failure.
89bio is actively advancing pegozafermin through various phases of clinical trials. Recently, the company announced a successful end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), allowing them to proceed to Phase 3 trials. Two Phase 3 trials, ENLIGHTEN-Cirrhosis and ENLIGHTEN-Fibrosis, are set to enroll patients in 2024. The ENLIGHTEN program aims to evaluate the efficacy and safety of pegozafermin in patients with different stages of liver fibrosis.
Pegozafermin has demonstrated strong anti-fibrotic and anti-inflammatory properties in the liver, as well as improved lipid metabolism, insulin resistance, and glycemic control. It has received Breakthrough Therapy designation from the FDA and Priority Medicines (PRIME) status from the European Medicines Agency (EMA), emphasizing its therapeutic potential and the urgency for such treatments.
Financially, 89bio reported substantial cash reserves, ensuring robust support for ongoing clinical activities. As of December 31, 2023, the company had $578.9 million in cash and equivalents. This strong financial position enables continued development and potential scaling up for commercial production.
89bio maintains strategic partnerships to bolster its clinical and commercialization efforts. These collaborations are crucial as the company aims to bring pegozafermin to market, providing solutions for patients with liver and cardio-metabolic diseases who lack effective treatment options.
For more detailed updates, recent financial results, and upcoming milestones, visit their official website or follow their LinkedIn profile.
89bio, Inc. (ETNB) announced positive results from its Phase 2b ENLIVEN trial of pegozafermin in patients with nonalcoholic steatohepatitis (NASH). The trial demonstrated statistically significant improvements in fibrosis and NASH resolution, with the 44mg Q2W and 30mg QW doses achieving placebo-adjusted effect sizes of 20% and 19% for fibrosis improvement, and 24% and 21% for NASH resolution, respectively. The study's results support progression to Phase 3 trials, highlighting pegozafermin’s potential as a differentiated treatment for NASH. The company’s rigorous methodology adds credibility to the findings.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its late-stage development program for pegozafermin. Key updates include topline results from the ENLIVEN Phase 2b trial for NASH, anticipated in Q1 2023, and FDA feedback supporting a Phase 3 program for severe hypertriglyceridemia (SHTG), with trials set to begin in Q2 2023. Financially, the company held $188.2 million in cash as of December 31, 2022, a rise from $150.7 million in 2021. However, net losses increased to $102 million for the year, driven by higher R&D and G&A expenses.
89bio, a clinical-stage biopharmaceutical company, presented additional findings from the Phase 2 ENTRIGUE trial at ACC.23/WCC, demonstrating that pegozafermin significantly reduced triglycerides and atherogenic lipids in patients with severe hypertriglyceridemia (SHTG).
The study involved 85 participants, showing a 62% reduction in triglycerides for patients not on background therapy and 68% for those on lipid-modifying therapy, compared to placebo. The overall success of pegozafermin supports advancing to a Phase 3 trial. This treatment is expected to offer new therapeutic options for SHTG, which affects millions in the U.S., presenting a compelling profile for cardiovascular risk reduction.
89bio, Inc. (Nasdaq: ETNB), a biopharmaceutical company, announced new data from its Phase 2 ENTRIGUE study on pegozafermin for treating severe hypertriglyceridemia (SHTG). The findings will be showcased at the American College of Cardiology's 72nd Annual Scientific Session in New Orleans from March 4-6, 2023. The study, titled 'Pegozafermin Provides Beneficial Lipid Effects in Subjects with Severe Hypertriglyceridemia,' indicates that the treatment could yield significant lipid benefits, regardless of patients' background lipid-modifying therapy. The poster presentation is scheduled for March 4, 2023.
89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company, announced participation in the SVB Securities Global Biopharma Conference on February 15, 2023, at 12:00 PM ET. Management will engage in a fireside chat and hold one-on-one investor meetings. The event will be available for viewing via a webcast, accessible on their website. 89bio is focused on developing innovative therapies for liver and cardio-metabolic diseases, rapidly advancing its lead candidate, pegozafermin, aimed at treating non-alcoholic steatohepatitis (NASH) and severe hypertriglyceridemia (SHTG). The company is headquartered in San Francisco.
89bio, a clinical-stage biopharmaceutical company, reported significant advancements in its clinical programs for pegozafermin. The company expects topline data from the ENLIVEN Phase 2b NASH trial in Q1 2023 and plans to initiate a Phase 3 trial for severe hypertriglyceridemia (SHTG) in H1 2023, following FDA feedback. Additionally, 89bio secured a $100 million credit facility from K2 HealthVentures, enhancing its financial position with pro forma cash of $188.4 million as of December 31, 2022. These steps signal a positive trajectory for the company's ongoing development of therapies targeting liver and cardio-metabolic diseases.
89bio, a clinical-stage biopharmaceutical company, announced positive results from its Phase 1b/2a study of pegozafermin for treating nonalcoholic steatohepatitis (NASH). Data published in The Lancet Gastroenterology & Hepatology revealed that up to 88% of patients showed a significant reduction in hepatic fat fraction. The treatment was well-tolerated with no severe adverse events, indicating its potential as a leading therapy for NASH. The company is advancing to the Phase 2b ENLIVEN trial, with topline results expected in Q1 2023.
89bio, Inc. (Nasdaq: ETNB) recently reported its Q3 2022 financial results, highlighting completion of enrollment in the Phase 2b ENLIVEN trial for NASH, with topline data expected in Q1 2023. The company also presented encouraging data from its Phase 1b/2a NASH study and the ENTRIGUE Phase 2 trial at major conferences. As of September 30, 2022, 89bio had cash and equivalents of $193.3 million, reporting a net loss of $26.8 million for Q3 2022. The firm anticipates initiating a Phase 3 trial for severe hypertriglyceridemia patients in the first half of 2023.
89bio, Inc. (Nasdaq: ETNB) presented new data from the Phase 1b/2a study on pegozafermin for treating nonalcoholic steatohepatitis (NASH) at the AASLD Liver Meeting 2022. In a post-hoc analysis of cohort 7, it was found that excluding patients with fibrosis stage 4 (F4) improved histological response rates. Out of 19 patients, 6 were identified as F4. Key findings included a 77% response rate for ≥ 2 point reduction in NAS after excluding F4 patients. The company aims to report topline data from the Phase 2b ENLIVEN trial in Q1 2023, further evaluating pegozafermin's efficacy.
89bio, a clinical-stage biopharmaceutical company focusing on therapies for liver and cardio-metabolic diseases, will participate in the H.C. Wainwright 6th Annual NASH Investor Conference on October 17, 2022, at 11:30 AM ET.
Management will engage in a fireside chat and one-on-one investor meetings. The presentation will be available via webcast, accessible here.
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