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- MASH 2B TRIALS- A SYSTEMATIC REVIEW () - Oct 15, 2024 - Abstract #AASLD2024AASLD_2363;
Lanifibranor and icosabutate showed promise, especially in T2D patients. FGF21 analogues like efruxifermin improved fibrosis, while FGF19 trials had variable results.
- COMPARATIVE EFFICACY OF PHARMACOLOGIC THERAPIES FOR MASH IN REDUCING LIVER FAT CONTENT: SYSTEMATIC REVIEW AND NETWORK META-ANALYSIS () - Oct 15, 2024 - Abstract #AASLD2024AASLD_2328;
This study provides an updated, relative rank-order efficacy of therapies for MASH in reducing hepatic fat as assessed by MRI-PDFF. These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy.
- pegozafermin (BIO89-100) / 89Bio
DIAGNOSTIC POTENTIAL OF FAST AND AGILE3+ SCORES FOR F2/F3 FIBROSIS: AN ANALYSIS OF THE PHASE 2 ENLIVEN STUDY () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1463;
Because AGILE3+ was designed to identify F3+ patients, it was less accurate in identifying the overall F2/F3 population. These data suggest the FAST score would likely be a viable tool to reduce screen failures in clinical trials targeting F2/F3 fibrosis and/or to aid in treatment-making decisions, in the real-world setting.
- pegozafermin (BIO89-100) / 89Bio
QUANTITATIVE ANALYSIS AND INTEGRATION OF MACHINE LEARNING FOR BIOMARKER ASSESSMENTS AND THEIR ASSOCIATION WITH TREATMENT RESPONSE: INSIGHTS FROM THE ENLIVEN PHASE 2B TRIAL OF PEGOZAFERMIN () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1457;
The cluster analysis identified three distinct groups which remained consistent across both unsupervised and supervised ML approaches. Longer treatment duration (>24 weeks) can have different or better histological treatment effect; the relationship associated with the identified biomarkers shall be further explored.
- pegozafermin (BIO89-100) / 89Bio
PEGOZAFERMIN REDUCED PROGRESSION TO CIRRHOSIS: A POST-HOC ANALYSIS FROM THE PHASE 2B ENLIVEN STUDY () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1330;
Relative to PBO F3 progressors, PGZ-treated progressors demonstrated improvement in histological disease activity and multiple liver-related NITs, indicating that PGZ may have clinical benefits even in patients with histological fibrosis progression. PGZ is currently being studied in Phase 3 studies in non-cirrhotic and cirrhotic MASH.
- pegozafermin (BIO89-100) / 89Bio
BIOMARKER RESPONSE IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) PATIENTS WITH HIGH-RISK BASELINE FAST SCORES: OBSERVATIONS FROM THE ENLIVEN PHASE2B TRIAL WITH PEGOZAFERMIN () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1314;
PGZ treatment in patients with a high FAST score at baseline shifted the majority to low-risk and was associated with benefit across various NITs over 48 weeks. These data suggest PGZ can be highly efficacious in non-cirrhotic patients with the greatest need for treatment.
- pegozafermin (BIO89-100) / 89Bio
"Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH" (Convention Center: Room 28ABCD) - Sep 29, 2024 - Abstract #AASLD2024AASLD_588;
- pegozafermin (BIO89-100) / 89Bio
Safety and Efficacy of Pegozafermin for Treatment of MASH and Hypertriglyceridemia: A Meta-Analysis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_5136;
The results showed that Pegozafermin increased adiponectin levels and decreased ALT levels, serum triglyceride levels. Moreover, it also showed that the Pegozafermin group had decreased liver volume (Combined effect: -208.96 ml, p < 0.0001) and decreased liver fat content (-8.36%) as compared to the placebo as shown in figure 1.
- aldafermin (NGM282) / NGM Biopharma, efruxifermin (AKR-001) / Akero Therap, pegozafermin (BIO89-100) / 89Bio
Fibroblast Growth Factor Analogues in Metabolic Dysfunction Associated Steatotic Liver Disease: A Network Meta-Analysis (Exhibit Hall E) - Aug 20, 2024 - Abstract #ACG2024ACG_3435;
Twelve RCTs comprising 1,420 patients with MASLD were included, involving four FGF agonists: efruxifermin, aldafermin, pegbelfermin, and pegozafermin at various doses. Most significant mean reduction in hepatic fat fraction (HFF) [MD = -67.98, 95% CI [-102.12; -33.84], P 30% [RR=4.68, 95% CI [2.57; 7.97], P1 stage without MASH worsening followed by efruxifermin at 50 mg ( P =0.04).
- || Retrospective data, Review, Journal: Comparative efficacy of pharmacologic therapies for MASH in reducing liver fat content: Systematic review and network meta-analysis. (Pubmed Central) - Jul 19, 2024
This study provides an updated, relative rank-order efficacy of therapies for MASH in reducing hepatic fat. These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy.
- || efruxifermin (AKR-001) / Akero Therap, pegozafermin (BIO89-100) / 89Bio
Retrospective data, Review, Journal: Efficacy and Safety of Fibroblast Growth Factor-21 Analogs for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis: A Systematic Review and Meta-Analysis. (Pubmed Central) - Jun 16, 2024
FGF-21 analogs were significantly better in achieving liver histological improvements and beneficial biochemical outcomes compared with placebo, with a tolerable safety pattern. These findings shed light on the efficacy and safety of FGF-21 analogs and provide valuable evidence for their application as MASH therapeutics.
- |||| pegozafermin (BIO89-100) / 89Bio
Trial primary completion date: Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH (clinicaltrials.gov) - Jun 13, 2024
P3, N=762, Recruiting, Sponsor: 89bio, Inc.
These findings shed light on the efficacy and safety of FGF-21 analogs and provide valuable evidence for their application as MASH therapeutics. Trial primary completion date: Apr 2030 --> Jun 2028
- pegozafermin (BIO89-100) / 89Bio
Study Design of a Phase 3 Randomized Controlled Trial Evaluating the Efficacy and Safety of Pegozafermin in Patients with Severe Hypertriglyceridemia (Kiosk 28) - Jun 12, 2024 - Abstract #NLA2024NLA_249;
P3
ENTRUST is a pivotal Phase 3 clinical trial designed to confirm the efficacy and safety of PGZ in the treatment of SHTG. Expected clinical benefits include significant reductions of triglycerides and hepatic steatosis, as well as other metabolic improvements.
- |||||||||| pegozafermin (BIO89-100) / 89Bio
New P3 trial: Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH (clinicaltrials.gov) - May 20, 2024
P3, N=762, Not yet recruiting, Sponsor: 89bio, Inc.
- Fibroblast Growth Factor 21 in the Diagnosis and Treatment of Metabolic Disorders (ENDOExpo PosterArea - BCEC) - May 5, 2024 - Abstract #ENDO2024ENDO_1910;
Serum FGF21 levels are increased in several metabolic disorders including obesity, NAFLD, dyslipidemia, and type 2 diabetes. FGF21 is an attractive target for the treatment of these metabolic disorders.
- || Mounjaro (tirzepatide) / Eli Lilly, pegozafermin (BIO89-100) / 89Bio
Review, Journal: NAFLD in the 21st Century: Current Knowledge Regarding Its Pathogenesis, Diagnosis and Therapeutics. (Pubmed Central) - Apr 27, 2024
Finally, we explore future perspectives regarding the administration of GLP-1 analogues, GIP agonists, and probiotics/prebiotics as a means to prevent and combat NAFLD. The newest drugs pegozafermin and resmetiron, which seem to be very promising, arealso discussed.
- pegozafermin (BIO89-100) / 89Bio
Week 48 results from the phase 2b ENLIVEN extension study investigating pegozafermin for the treatment of metabolic dysfunction-associated steatohepatitis with fibrosis (Space 1+2) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2329;
PGZ continues to demonstrate a favorable safety and tolerability profile. Confirmatory phase 3 studies are planned for 2024.
- efruxifermin (AKR-001) / Akero Therap, pegozafermin (BIO89-100) / 89Bio
Efficacy and safety of FGF21 analogues in the treatment of metabolic dysfunction-associated steatohepatitis: an updated systematic review and meta-analysis (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2117;
FGF21 analogues seem effective and safe in obese patients with biopsy-confirmed MASH, but the clinical benefit may be restricted to non-cirrhotic patients. New RCTs are necessary establish FGF21 analogues as a therapy for MASH.
- pegozafermin (BIO89-100) / 89Bio
Pegozafermin added to background GLP-1 therapy in patients with metabolic dysfunction-associated steatohepatitis with F2/F3 fibrosis: ENLIVEN 48-week extension data (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2101;
In MASH patients with F2/F3 fibrosis who were receiving background GLP-1 therapy, addition of PGZ demonstrated additional and sustained improvement in markers of liver and metabolic health compared to GLP-1 therapy alone. Confirmatory phase 3 studies are planned to begin in 2024 and will include patients on background incretin therapies per local standard of care.
- pegozafermin (BIO89-100) / 89Bio
Prediction of metabolic dysfunction-associated steatohepatitis resolution (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_606;
This prospective study included 163 participants (64% female) with biopsy-proven MASH and stage 2 or stage 3 fibrosis from a randomized, multicenter, placebo-controlled trial of pegozafermin, a fibroblast growth factor 21 analog... The MASH Resolution Index has superior diagnostic accuracy for MASH Resolution, compared to the FAST score.
- |||||| pegozafermin (BIO89-100) / 89Bio
Enrollment open: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants with MASH and Fibrosis (ENLIGHTEN-Fibrosis) (clinicaltrials.gov) - Mar 24, 2024
P3, N=1050, Recruiting, Sponsor: 89bio, Inc.
The MASH Resolution Index has superior diagnostic accuracy for MASH Resolution, compared to the FAST score. Not yet recruiting --> Recruiting
- |||||||||| pegozafermin (BIO89-100) / 89Bio
New P3 trial: A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants with MASH and Fibrosis (ENLIGHTEN-Fibrosis) (clinicaltrials.gov) - Mar 18, 2024
P3, N=1050, Not yet recruiting, Sponsor: 89bio, Inc.
- pegozafermin (BIO89-100) / 89Bio
SINGLE CELL RNASEQ ANALYSIS OF FIBROBLAST GROWTH FACTOR RECEPTOR (FGFR) EXPRESSION IN FIBROTIC LIVER PATHOLOGY (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_5880;
In a randomized trial involving patients with MASH and moderate or severe fibrosis, pegozafermin, an FGF21 analogue, demonstrated significant improvements in fibrosis compared to placebo...The data presented contribute to the growing body of evidence supporting the exploration of FGF analogues in clinical trials, emphasizing their potential as a therapeutic approach for fibrotic liver diseases. Future research should focus on the implications of FGFR overexpression and the therapeutic potential of modulating these pathways.
- | Parmodia (pemafibrate) / Kowa
Journal: Pemafibrate and other triglyceride-lowering therapies to reduce risk of cardiovascular and metabolic disease. (Pubmed Central) - Mar 14, 2024
Taken together, HTG is associated with increased risk of CVD and attendant adverse metabolic sequalae. To this end, a potentially promising and evidence-based landscape is emerging for treating a clinical phenotype that in the past has been insufficiently addressed.
- || pegozafermin (BIO89-100) / 89Bio
Review, Journal: NAFLD and NASH: etiology, targets and emerging therapies. (Pubmed Central) - Mar 11, 2024
(THR?) agonist resmetriom on hepatic fat content, NASH resolution and/or fibrosis regression. Future directions of NAFLD and NASH research are also discussed in this state-of-the-art review.
- Comparative efficacy of pharmacologic therapies in MASH: Systematic review and meta-analysis (New Hall) - Jan 6, 2024 - Abstract #APASL2024APASL_707;
For MRI-PDFF response, Aldafermin (SUCRA = 92.61), Efruxifermin (SUCRA = 81.00) and Resmetirom (SUCRA = 55.54) had the highest probability of being ranked the most effective intervention for achieving MRI-PDFF response at week 12. These data provide relative rank-order efficacy of various MASH therapies in terms of improvements in MRI-PDFF.
- | pegozafermin (BIO89-100) / 89Bio
Journal: Randomized Trial of Pegozafermin in NASH. Reply. (Pubmed Central) - Dec 6, 2023
These data provide relative rank-order efficacy of various MASH therapies in terms of improvements in MRI-PDFF. No abstract available
- | pegozafermin (BIO89-100) / 89Bio
Journal: Randomized Trial of Pegozafermin in NASH. (Pubmed Central) - Dec 6, 2023
No abstract available No abstract available
- | pegozafermin (BIO89-100) / 89Bio
Journal, Biopsy: Clinical trial: Effects of pegozafermin on the liver and on metabolic comorbidities in subjects with biopsy-confirmed nonalcoholic steatohepatitis. (Pubmed Central) - Oct 30, 2023
P1/2
No abstract available Pegozafermin treatment for 20?weeks had beneficial effects on hepatic and metabolic parameters and was well tolerated in subjects with NASH.
- || pegozafermin (BIO89-100) / 89Bio
Review, Journal: Pegozafermin Is a Potential Master Therapeutic Regulator in Metabolic Disorders: A Review. (Pubmed Central) - Oct 27, 2023
This emerging pharmaceutical compound has shown promise in treating liver fibrosis and inflammation linked to nonalcoholic steatohepatitis. The ENTRIGUE trial, a phase 2 clinical trial of PGZ, has demonstrated a 57% reduction in triglyceride level compared to placebo; a 45% reduction in liver hepatic steatosis; improved insulin sensitivity; reductions in nonhigh-density lipoprotein-cholesterol; and reductions in apolipoprotein B-100.
- pegozafermin (BIO89-100) / 89Bio
FIBROSIS IMPROVEMENT WITH PEGOZAFERMIN TREATMENT IN MASH PATIENTS WITH F4 FIBROSIS: ANALYSIS FROM A 24-WEEK RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2 TRIAL (ENLIVEN) (Ballroom BC) - Oct 11, 2023 - Abstract #AASLD2023AASLD_848;
In addition to regression of fibrosis, reductions were observed in liver specific biomarkers of fibrogenesis/ fibrosis (ProC3 and FAST) and inflammation (ALT). Pegozafermin appears to maintain a safety and tolerability profile in patients with compensated cirrhosis comparable to those with less advanced disease (MASH with F2/F3 fibrosis).
- | pegozafermin (BIO89-100) / 89Bio
Journal: Pegozafermin for NASH - A Sprint to Start a Marathon. (Pubmed Central) - Sep 17, 2023
Pegozafermin appears to maintain a safety and tolerability profile in patients with compensated cirrhosis comparable to those with less advanced disease (MASH with F2/F3 fibrosis). No abstract available
- || pegozafermin (BIO89-100) / 89Bio
PK/PD data, Journal: Population Pharmacokinetics and Pharmacodynamics of Pegozafermin in Patients with Nonalcoholic Steatohepatitis (NASH). (Pubmed Central) - Sep 11, 2023
P1/2, P2
Furthermore, 44 mg Q2W dosing (~22 mg QW) appeared to be an effective regimen for HFF reduction. Our modeling supports the feasibility of QW and Q2W dosing for achieving favorable treatment outcomes in patients with NASH, and provides the rationale for dose selection for the phase 2b ENLIVEN study (NCT04929483).
- | pegbelfermin (BMS-986036) / BMS, pegozafermin (BIO89-100) / 89Bio
Journal: The Novel GlycoPEGylated FGF21 Analog Pegozafermin Activates Human FGF Receptors and Improves Metabolic and Liver Outcomes in Diabetic Monkeys and Healthy Human Volunteers. (Pubmed Central) - Aug 10, 2023
Studies presented here demonstrate that a novel long-acting FGF21 analog, pegozafermin, has similar pharmacologic properties as FGF21 and that repeated, subcutaneous-dosing of pegozafermin in diabetic monkeys and healthy humans improves lipid metabolism, glucose metabolism, weight and liver transaminases. These results support future development of pegozafermin for the treatment of metabolic diseases, including nonalcoholic steatohepatitis and severe hypertriglyderidemia.
- || pegozafermin (BIO89-100) / 89Bio
Trial completion date, Biopsy: ENLIVEN: Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jul 28, 2023
P2, N=222, Active, not recruiting, Sponsor: 89bio, Inc.
These results support future development of pegozafermin for the treatment of metabolic diseases, including nonalcoholic steatohepatitis and severe hypertriglyderidemia. Trial completion date: Sep 2023 --> Sep 2024
- || pegozafermin (BIO89-100) / 89Bio
P2b data, Journal: Pegozafermin for NASH and fibrosis: phase IIb results. (Pubmed Central) - Jul 26, 2023
Trial completion date: Sep 2023 --> Sep 2024 No abstract available
- || pegozafermin (BIO89-100) / 89Bio
P2 data, Journal: The FGF21 analog pegozafermin in severe hypertriglyceridemia: a randomized phase 2 trial. (Pubmed Central) - Jul 21, 2023
No serious adverse events were observed to be related to the study drug. If these results are confirmed in a phase 3 trial, pegozafermin could be a promising treatment for SHTG (ClinicalTrials.gov registration: NCT0441186).
- |||| pegozafermin (BIO89-100) / 89Bio
On summer vacay? @EASLCongress 2023 recap for beach reading: What you may have missed; alcohol use, NASH data top agenda. via @HealioGastro #NASH #MASH #Pegozafermin @DrLoomba https://t.co/F8u4LAmRuE (Twitter) - Jul 17, 2023
- ||||| pegozafermin (BIO89-100) / 89Bio
Clinical, Biopsy: For patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage F2 or F3 fibrosis, treatment with pegozafermin leads to improvements in fibrosis. Study in @NEJMGroup. @DrLoomba @KowdleyMd @DLBHATTMD https://t.co/bSEYUP7Nzm (Twitter) - Jul 14, 2023
- |||| pegozafermin (BIO89-100) / 89Bio
Clinical: The authors concluded Pegozafermin significantly improved: Fibrosis improvement without worsening of NASH NASH resolution without worsening of fibrosis Non-invasive tests Efficacy similar with weekly and every-two-week dosing intervals Favorable safety and tolerability profile (Twitter) - Jul 11, 2023
- |||| pegozafermin (BIO89-100) / 89Bio
Pegozafermin Demonstrated Significant Improvements on Non-Invasive Markers (NITs) for Fibrosis (Twitter) - Jul 11, 2023
- ||| pegozafermin (BIO89-100) / 89Bio
Pegozafermin Demonstrated Robust Liver Fat Reduction with High Responder Rates by MRI-PDFF at Week 24 (Twitter) - Jul 11, 2023
- ||| pegozafermin (BIO89-100) / 89Bio
Pegozafermin Treatment Led to a Significant Improvement on Primary Endpoints at Week 24 #livertwitter #GITwitter (Twitter) - Jul 11, 2023
- ||||| pegozafermin (BIO89-100) / 89Bio
Emerging data suggests a long-acting FGF21 analogue (pegozafermin) has therapeutic potential for NASH #89Bio (Twitter) - Jul 11, 2023
- ||| pegozafermin (BIO89-100) / 89Bio
“@DrLoomba and team found that the drug Pegozafermin mimics fibroblast growth factor 21 (FGF21)—a liver-secreted peptide hormone that is naturally produced in the body. FGF21 controls energy use in the body and lipid metabolism in the liver. It has also been shown in previous… https://t.co/JnrUMGxtZB (Twitter) - Jul 2, 2023
- |||| pegozafermin (BIO89-100) / 89Bio
Clinical, Late-breaking abstract: #Pegozafermin significantly improved #fibrosis without worsening of #NASH, and vice versa, with similar efficacy reported at weekly and biweekly dosing intervals, according to late-breaker data presented by @DrLoomba at #EASLCongress. https://t.co/XDpKQqmAKw (Twitter) - Jun 26, 2023
- ||| pegozafermin (BIO89-100) / 89Bio
#Pegozafermin improves #fibrosis, shows promise as ‘mainstay treatment’ for #NASH @DrLoomba #EASLCongress #EASL23 #LiverTwitter https://t.co/PrrfrRngNV (Twitter) - Jun 26, 2023
- |||| pegozafermin (BIO89-100) / 89Bio
Clinical: In a phase 2 randomized clinical trial in patients with severe hypertriglyceridemia, pegozafermin, a long-acting analog of human FGF21, was safe and met the primary endpoint of the trial for reducing serum triglyceride levels @DLBHATTMD @IcahnMountSinai https://t.co/fVDZjMI2Bo (Twitter) - Jun 26, 2023
- | pegozafermin (BIO89-100) / 89Bio
Journal: Randomized, Controlled Trial of the FGF21 Analogue Pegozafermin in NASH. (Pubmed Central) - Jun 25, 2023
P2
These results support the advancement of pegozafermin into phase 3 development. (Funded by 89bio; ENLIVEN ClinicalTrials.gov number, NCT04929483.).
- ||| resmetirom (MGL-3196) / Madrigal Pharma, pegozafermin (BIO89-100) / 89Bio
Thanks for reporting from EASL-Vienna❗ Noticed two RCTs showing 👇 fibrosis in NASH: 1⃣ Resmetirom (THRb agonist), MAESTRO-NASH trial, Stephen Harrison 2️⃣ Pegozafermin (FGF21 analog), ENLIVEN trial @DrLoomba also in @NEJM Any other such RCTs❓ Heady times❗ https://t.co/88YpxaFLr4 (Twitter) - Jun 25, 2023