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- |||| efruxifermin (AKR-001) / Amgen, lanifibranor (IVA337) / Inventiva
MORE: https://t.co/tfO3g8dXra #89bio @akerolabs @bmsnews #efruxifermin #Elastography #lanifibranor #MRIPDFF #NAFLD #NASH #noninvasivelivertesting #Semaglutide @MayoClinic Dr. @AlinaAllenMD #Histopathology @NaturePortfolio (Twitter) - Sep 30, 2021
- || efruxifermin (AKR-001) / Amgen
Clinical, P2a data, Journal: Efruxifermin in non-alcoholic steatohepatitis: a randomized, double-blind, placebo-controlled, phase 2a trial. (Pubmed Central) - Sep 25, 2021
P2a
The most commonly reported drug-related TEAEs were grade 1-2 gastrointestinal (36 (46%)). Treatment with efruxifermin significantly reduced HFF in patients with F1-F3 stage NASH, with an acceptable safety profile.
- ||||| efruxifermin (AKR-001) / Akero Therap
New P2b trial: A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry) (clinicaltrials.gov) - Sep 8, 2021
P2b, N=200, Recruiting, Sponsor: Akero Therapeutics, Inc
- ||| efruxifermin (AKR-001) / Amgen
Clinical, P3 data: Topics : @akerolabs @bmsnews #cirrhosis #DiagnosticTests #DrugTrial #EASL #efruxifermin #ELF #FattyLiver #FGF21 #FibroScan #FibrosisLevel3 #FibrosisLevel4 @GlobalLiver #MRIPDFF #NAFLD #NASH #noninvasivelivertesting @novonordisk #Phase3 #Semaglutide #MRElastography #Resoundant (Twitter) - Aug 26, 2021
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Increased Adiponectin following Efruxifermin Treatment Is Associated with Improvements in Dyslipidemia, Glucose Metabolism, and Liver Health in a 16-Week, Randomized, Placebo-Controlled NASH Trial () - May 29, 2021 - Abstract #ADA2021ADA_1721;
These data suggest adipose tissue-mediated effects of EFX contribute substantially to restoration of liver health, healthy lipoprotein profiles, insulin sensitivity and glucose tolerance. 1 Harrison 2020 Hepatol 72 1S; 6A
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Efruxifermin Is Associated with Improved Glucose Metabolism in Patients with NASH and Type 2 Diabetes () - May 29, 2021 - Abstract #ADA2021ADA_1718;
2020. Hepatology, 72; 1S; 6A
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Efruxifermin (EFX) improved markers of fibrosis, liver injury and metabolism in F4 NASH patients with compensated cirrhosis () - May 26, 2021 - Abstract #EASLILC2021EASL_ILC_1345;
EFX 50mg was safe and well-tolerated in F4 NASH patients, who have the greatest risk of progressing to ESLD. EFX showed trends to reverse cirrhosis on semi-quantitative histopathologic assessment with significant reductions in key non-invasive markers of liver injury and fibrosis, and improved markers of glucose and lipid metabolism, consistent with results of the main study in F1–F3 NASH patients.
- | efruxifermin (AKR-001) / Amgen
Trial completion date: Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 11, 2021
P2b, N=160, Recruiting, Sponsor: Akero Therapeutics, Inc
EFX showed trends to reverse cirrhosis on semi-quantitative histopathologic assessment with significant reductions in key non-invasive markers of liver injury and fibrosis, and improved markers of glucose and lipid metabolism, consistent with results of the main study in F1–F3 NASH patients. Trial completion date: Mar 2027 --> Feb 2024
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Correlation between changes in liver fat content and improvements in serum markers of liver injury, fibrosis, metabolism, and in histologic parameters following treatment with efruxifermin (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_917;
Treatment with EFX resulted in a significant reduction in LFC which correlatedwith improvements inmarkers of liver injury, fibrosis, metabolic parameters and histologic features. EFX treatment has the potential to significantly improve all aspects of the pathophysiology of NASH with fibrosis.
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] The role of reduction in liver fat content (MRI-PDFF) and ALT in predicting treatment response in NASH: A secondary analysis of the randomized, controlled BALANCED trial (Poster area) - Apr 9, 2021 - Abstract #EASLILC2021EASL_ILC_914;
Background and aims: Efruxifermin (EFX) treatment resulted in significantly greater reduction in liver fat content (LFC) as assessed by MRI-PDFFafter 12wks compared to placebo, andwas associatedwith NASH resolution and fibrosis improvement at wk 16–20 liver biopsy assessment.1 Because of the consistently large reductions of liver fat, this study provides a unique dataset to evaluate the utility of a decline in serum ALTof ≥17 U/L among MRI-PDFF responders (≥30% decline) for predicting histologic response in NASH when used alone or combined with normalization of liver fat (≤5% by MRI-PDFF) at wk 12... Among MRI-PDFF responders, a decline in serum ALT of at least 17 U/L is a robust marker in predicting NASH resolution for EFX and potentially other metabolic therapies with a potent anti- steatotic effect.
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Generation of Affinity Purified Antibody Reagents for Specific Determination of Efruxifermin in Biological Matrices () - Mar 27, 2021 - Abstract #ENDO2021ENDO_3211;
For oral presentations, the abstracts are embargoed until the session begins. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021.
- ||||| efruxifermin (AKR-001) / Amgen
Efruxifermin (FGF-21) by #Akero in #NASH #cirrhosis. Only 16 wks! Very Small numbers, voluntary biopsy at endpoint, but fibroscan/ELF included. Too good too be true? @IanARowe @phil_newsome7 @DrLoomba (Twitter) - Mar 23, 2021
- || efruxifermin (AKR-001) / Amgen
Trial completion date, Trial primary completion date: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Mar 12, 2021
P2a, N=110, Active, not recruiting, Sponsor: Akero Therapeutics, Inc
The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO 2021. Trial completion date: Feb 2021 --> Aug 2021 | Trial primary completion date: Mar 2020 --> Feb 2021
- efruxifermin (AKR-001) / Amgen
Efruxifermin () - Mar 7, 2021 - Abstract #NASHTAG2021NASH-TAG_70;
- ||| efruxifermin (AKR-001) / Amgen
Enrollment open: Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 25, 2021
P2b, N=160, Recruiting, Sponsor: Akero Therapeutics, Inc
Trial completion date: Feb 2021 --> Aug 2021 | Trial primary completion date: Mar 2020 --> Feb 2021 Not yet recruiting --> Recruiting
- ||||| efruxifermin (AKR-001) / Amgen
New P2b trial: Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 22, 2021
P2b, N=160, Not yet recruiting, Sponsor: Akero Therapeutics, Inc
- || AKR-001 / Amgen
I'm wondering instead if glycogenolysis is involved. The study by Kaufman et al. also proposes an increase in hepatic glucose output due to increased glucagon levels following AKR-001 administration. Not sure about the glucagon part, but something may be going on with glycogen. (Twitter) - Dec 28, 2020
- || AKR-001 / Amgen
Clinical, PK/PD data, Journal: AKR-001, an Fc-FGF21 Analog, Showed Sustained Pharmacodynamic Effects on Insulin Sensitivity and Lipid Metabolism in Type 2 Diabetes Patients. (Pubmed Central) - Nov 21, 2020
Positive trends in lipoprotein profile, including triglycerides, non-high-density lipoprotein (non-HDL) cholesterol, HDL-C, and apolipoproteins B and C3 are consistent with other FGF21 analogs. AKR-001's clinical profile supports further evaluation as a treatment for metabolic diseases.
- || efruxifermin (AKR-001) / Amgen
Enrollment closed: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Oct 19, 2020
P2a, N=110, Active, not recruiting, Sponsor: Akero Therapeutics, Inc
AKR-001's clinical profile supports further evaluation as a treatment for metabolic diseases. Recruiting --> Active, not recruiting
- AKR-001 / Amgen
[VIRTUAL] FGF21 directly modulates human liver and adipose physiology in vitro, displaying a range of biological activities independent of FGFR4 agonism (Poster Area) - Aug 31, 2020 - Abstract #EASLILCI2020EASL-ILC-I-2274;
These actions appeared to be mediated by receptors FGFR1c/2c/3c, since agonism of FGFR4 by FGF19 did not seem to contribute additional activity in these tissues. We believe these findings support the potential use of AKR-001 as a therapeutic in NASH patients, which we are currently evaluating in a phase 2a clinical trial.
- ||| efruxifermin (AKR-001) / Amgen
Enrollment open: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - May 11, 2020
P2a, N=110, Recruiting, Sponsor: Akero Therapeutics, Inc
We believe these findings support the potential use of AKR-001 as a therapeutic in NASH patients, which we are currently evaluating in a phase 2a clinical trial. Active, not recruiting --> Recruiting
- || efruxifermin (AKR-001) / Amgen
Enrollment closed, Trial completion date: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Apr 13, 2020
P2a, N=110, Active, not recruiting, Sponsor: Akero Therapeutics, Inc
Active, not recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Sep 2020 --> Dec 2020
- | pegbelfermin (BMS-986036) / BMS, AKR-001 / Amgen
Journal: Fibroblast growth factor (FGF)-21 based therapies: A magic bullet for nonalcoholic fatty liver disease (NAFLD)? (Pubmed Central) - Feb 15, 2020
Targeting of the FGF21/FGFR/β-Klotho pathway may halt or reverse hepatic fat infiltration, inflammation and fibrosis.Areas Covered: This article summarizes preclinical and clinical data on the efficacy and safety of two FGF21 agonist therapies in developmentExpert Opinion: Preclinical and clinical data justify further investigation of FGF21 agonist therapies for the treatment of NAFLD. However, issues including injection site reactions and possible effects on bone homeostasis means that safety must be evaluated carefully.
- AKR-001 / Amgen
Akr-001, an engineered fc-fgf21 variant, directly modulates human liver and adipose tissue physiology, exerting beneficial metabolic, anti-inflammatory, and anti-fibrotic effects without fgfr4 agonism (Poster Area) - Feb 2, 2020 - Abstract #EASLILC2020EASL-ILC_1770;
- ||| efruxifermin (AKR-001) / Amgen
Enrollment change, Trial completion date: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jan 18, 2020
P2a, N=110, Recruiting, Sponsor: Akero Therapeutics, Inc
However, issues including injection site reactions and possible effects on bone homeostasis means that safety must be evaluated carefully. N=80 --> 110 | Trial completion date: Jun 2020 --> Sep 2020
- | efruxifermin (AKR-001) / Amgen
New P2a trial: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Jun 5, 2019
P2a, N=80, Recruiting, Sponsor: Akero Therapeutics, Inc
- efruxifermin (AKR-001) / Akero Therap
Enrollment change, Trial termination, Trial primary completion date: Multiple Ascending Dose Study in Subjects With Type 2 Diabetes (clinicaltrials.gov) - Oct 10, 2014
P1, N=86, Terminated, Sponsor: Amgen
N=124 --> 86 | Recruiting --> Terminated | Trial primary completion date: Mar 2015 --> Sep 2014; This study was terminated on August 29th, 2014 due to a business decision by the Sponsor. The study was not terminated due to a safety reason.
- || efruxifermin (AKR-001) / Akero Therap
Trial primary completion date: Multiple Ascending Dose Study in Subjects With Type 2 Diabetes (clinicaltrials.gov) - Jul 30, 2014
P1, N=124, Recruiting, Sponsor: Amgen
The study was not terminated due to a safety reason. Trial primary completion date: Sep 2014 --> Mar 2015
- || efruxifermin (AKR-001) / Akero Therap
Enrollment change: Multiple Ascending Dose Study in Subjects With Type 2 Diabetes (clinicaltrials.gov) - Feb 27, 2014
P1, N=124, Recruiting, Sponsor: Amgen
Trial primary completion date: Sep 2014 --> Mar 2015 N=48 --> 124
- ||| efruxifermin (AKR-001) / Akero Therap
New P1 trial: Multiple Ascending Dose Study in Subjects With Type 2 Diabetes (clinicaltrials.gov) - May 16, 2013
P1, N=124, Recruiting, Sponsor: Amgen
- efruxifermin (AKR-001) / Akero Therap
Trial termination: Single Ascending Dose Trial in Patients With Type 2 Diabetes (clinicaltrials.gov) - Feb 12, 2013
P1, N=47, Terminated, Sponsor: Amgen
N=48 --> 124 Recruiting --> Terminated; Decision by Sponsor
- efruxifermin (AKR-001) / Akero Therap
New P1 trial: Single Ascending Dose Trial in Patients With Type 2 Diabetes (clinicaltrials.gov) - Dec 13, 2011
P1, N=47, Terminated, Sponsor: Amgen