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- || efruxifermin (AKR-001) / Akero Therap
P2 data, Journal, Combination therapy: Safety and Efficacy of Efruxifermin in Combination With a GLP-1 Receptor Agonist in Patients With NASH/MASH and Type 2 Diabetes in a Randomized Phase 2 Study. (Pubmed Central) - Dec 22, 2024
P2b
The tolerability profile of efruxifermin added to GLP-1RA appeared comparable to that of either drug alone, while also significantly reducing HFF and noninvasive markers of fibrosis in patients with MASH and T2D. Liver health in patients already on a GLP-1RA may be further improved by addition of efruxifermin.
- | efruxifermin (AKR-001) / Akero Therap
Preclinical, Journal: Construction and Expression of Fc-FGF21 by Different Expression Systems and Comparison of Their Similarity and Difference with Efruxifermin by In Vitro and In Vivo Studies. (Pubmed Central) - Dec 19, 2024
Taken together, this study demonstrates a good example of how to develop and validate a biosimilar for therapeutic purposes. In future, more efforts, such as mutation to FGF21 or linking FGF21 with effective antibody to form dual targets, could be done to obtain more effective FGF21 analogs.
- || pemvidutide (ALT-801) / Altimmune
Clinical, Journal: Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. (Pubmed Central) - Dec 18, 2024
P1
In future, more efforts, such as mutation to FGF21 or linking FGF21 with effective antibody to form dual targets, could be done to obtain more effective FGF21 analogs. In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo.
- ||||| efruxifermin (AKR-001) / Akero Therap
Enrollment change, Trial completion date, Trial primary completion date: AK-US-001-0105: A Study Evaluating Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis (clinicaltrials.gov) - Oct 16, 2024
P3, N=1650, Recruiting, Sponsor: Akero Therapeutics, Inc
In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to placebo. N=1000 --> 1650 | Trial completion date: Mar 2027 --> Nov 2032 | Trial primary completion date: Dec 2026 --> Nov 2032
- 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.
- efruxifermin (AKR-001) / Akero Therap
EFRUXIFERMIN SIGNIFICANTLY IMPROVED LIVER FIBROSIS AT WEEK 96 IN THE HARMONY STUDY ACROSS SUBGROUPS AND IMPROVEMENTS WERE ASSOCIATED WITH CHANGES IN BIOMARKERS () - Oct 15, 2024 - Abstract #AASLD2024AASLD_1348;
These data may help inform the design and sample size calculation of future clinical trials and assist selection of combination therapy. The anti-fibrotic effects observed at Week 24 in patients with MASH and F2
- 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).
- |||||||||| efruxifermin (AKR-001) / Akero Therap
New P3 trial: AK-US-001-0106: A Study Evaluating Efruxifermin in Subjects with Compensated Cirrhosis Due to NASH/MASH (clinicaltrials.gov) - Jul 29, 2024
P3, N=1150, Recruiting, Sponsor: Akero Therapeutics, Inc
- || 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.
- efruxifermin (AKR-001) / Akero Therap
Insulin-Sensitizing Effects of Efruxifermin Improve Glycemic Control in Patients with MASH and Type 2 Diabetes (Poster Hall (West A4-B2); 897) - May 20, 2024 - Abstract #ADA2024ADA_2904;
EFX has consistently improved markers of whole-body glucose and lipid metabolism in patients with MASH and T2D, even on top of stable T2D medications including GLP-1RA. EFX-mediated insulin sensitization may potentiate effects of insulin or insulin secretagogues, possibly enabling patients to reduce use of insulin and/or other T2D medications to mitigate weight gain, incidence of hypoglycemia, or other side effects.
- Mounjaro (tirzepatide) / Eli Lilly, efruxifermin (AKR-001) / Akero Therap
Tirzepatide and Efruxifermin Demonstrate Therapeutic Benefits for NASH in a Preclinical Metabolic Syndrome Animal Model, B6-Alms1-del Mice (Poster Hall (West A4-B2); 1639) - May 20, 2024 - Abstract #ADA2024ADA_2586;
Consistently, Efruxifermin treatment exhibited more significant NASH resolution than Tirzepatide treatment.In summary, we demonstrated the therapeutic effects of Tirzepatide and Efruxifermin in B6-Alms1-del mice, which aligned with recent clinical observations. Consequently, B6-Alms1-del mice could serve as a valuable model for preclinical studies of anti-NASH agents targeting GLP-1R/GIPR and FGF21.
- efruxifermin (AKR-001) / Akero Therap
Efruxifermin significantly reduced liver fibrosis in MASH patients with F2 (Gold Room) - Apr 29, 2024 - Abstract #EASLILC2024EASL_ILC_2712;
- || efruxifermin (AKR-001) / Akero Therap
Biomarker, Retrospective data, Review, Journal, MRI: Efficacy of pharmacologic interventions on magnetic resonance imaging biomarkers in patients with nonalcoholic fatty liver disease: systematic review and network meta-analysis. (Pubmed Central) - Apr 17, 2024
Consequently, B6-Alms1-del mice could serve as a valuable model for preclinical studies of anti-NASH agents targeting GLP-1R/GIPR and FGF21. Several drug classes may reduce LFC in patients with NAFLD without a significant effect on fibrosis; nevertheless, trial duration was small, and confidence in the effect estimates was low.
- efruxifermin (AKR-001) / Akero Therap
Efruxifermin treatment improved collagen biomarkers consistent with remodelling of the extracellular matrix in patients with F2-F3 fibrosis due to MASH (Poster Area) - Apr 2, 2024 - Abstract #EASLILC2024EASL_ILC_2131;
Several drug classes may reduce LFC in patients with NAFLD without a significant effect on fibrosis; nevertheless, trial duration was small, and confidence in the effect estimates was low. Together, these results suggest overall beneficial remodelling of the ECM and modulation of markers of pathological fibrosis consistent with improvements in metabolic health, liver health, and suppression of fibrogenesis following EFX treatment.
- 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.
- |||||||||| efruxifermin (AKR-001) / Akero Therap
New P3 trial: AK-US-001-0105: A Study Evaluating Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis (clinicaltrials.gov) - Jan 22, 2024
P3, N=1000, Recruiting, Sponsor: Akero Therapeutics, Inc
- 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.
- |||||||||| efruxifermin (AKR-001) / Akero Therap
New P3 trial: AK-US-001-0107: A Study Evaluating Efruxifermin in Subjects with Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) (clinicaltrials.gov) - Dec 8, 2023
P3, N=600, Recruiting, Sponsor: Akero Therapeutics, Inc
- | efruxifermin (AKR-001) / Amgen
Journal: Efruxifermin in non-alcoholic steatohepatitis. (Pubmed Central) - Nov 13, 2023
These data provide relative rank-order efficacy of various MASH therapies in terms of improvements in MRI-PDFF. No abstract available
- || efruxifermin (AKR-001) / Amgen
P2b data, Journal: Safety and efficacy of once-weekly efruxifermin versus placebo in non-alcoholic steatohepatitis (HARMONY): a multicentre, randomised, double-blind, placebo-controlled, phase 2b trial. (Pubmed Central) - Nov 13, 2023
P2b
No abstract available Efruxifermin improved liver fibrosis and resolved NASH over 24 weeks in patients with F2 or F3 fibrosis, with acceptable tolerability, supporting further assessment in phase 3 trials.
- efruxifermin (AKR-001) / Amgen
EFRUXIFERMIN IN COMPENSATED CIRRHOSIS DUE TO NASH/MASH: RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2b TRIAL (SYMMETRY) () - Nov 11, 2023 - Abstract #AASLD2023AASLD_2815;
P2b
Patients had significant rates of NASH resolution, reductions in markers of liver injury and fibrosis, and improvements in markers of glucose and lipid metabolism. These changes may translate to additional improvements in liver fibrosis by the end of the study (Week 96).
- || Lipaglyn (saroglitazar) / Zydus Lifesci, efruxifermin (AKR-001) / Amgen, lanifibranor (IVA337) / Inventiva
Review, Journal: Emerging therapeutic options for non-alcoholic fatty liver disease: A systematic review. (Pubmed Central) - Sep 13, 2023
The data analyzed in this review showed clinically significant improvement in individual histological features of NAFLD in both animal and human trials for all four classes, as well as good safety profiles (P < 0.05). We believe this compilation of information will have positive clinical implications in obtaining an FDA-approved therapy for NAFLD.
- || efruxifermin (AKR-001) / Amgen
Review, Journal: Efruxifermin, an investigational treatment for fibrotic or cirrhotic non-alcoholic steatohepatitis (NASH). (Pubmed Central) - Jul 17, 2023
While some other FGF-21 agonists (e.g. pegbelfermin) are currently not further investigated, available evidence supports the development of EFX as a promising anti-NASH drug in fibrotic and cirrhotic populations. However, antifibrotic efficacy, long-term safety and benefits (i.e. cardiovascular risk, decompensation events, disease progression, liver transplantation, mortality) remain to be determined.
- |||| efruxifermin (AKR-001) / Amgen
Go FGF21 agonism! Efruxifermin alone decreases A1C and improves glucose homeostasis. Being actively pursued by Boston Pharma and 89Bio as well. (Twitter) - Jun 5, 2023
- efruxifermin (AKR-001) / Amgen
Characterization of the patterns of resolution of histopathology after efruxifermin treatment of patients with NASH fibrosis (F2/3) for 24 weeks (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1943;
EFX 50mg demonstrated striking rates of ballooning resolution, associated with improved NAS, SAF-Activity and total SAF scores. Resolution of histopathology was mirrored by normalization of non-invasive biomarkers of NASH disease activity (ALT, AST) and fibrogenesis (Pro-C3) in the majority (>60%) of treated patients.3 Evaluation of qualitative patterns of regression of NASH and fibrosis with EFX may be useful in understanding the breadth of response across the NASH population and assessing the potential for further improvements with longer-term treatment.
- efruxifermin (AKR-001) / Amgen
Noninvasive tests of liver injury, inflammation and fibrosis are improved by efruxifermin and correlate with histological improvements in F2-F3 NASH patients: secondary analysis of Ph2b HARMONY study (Poster Area) - Apr 12, 2023 - Abstract #EASLILC2023EASL_ILC_1928;
In a substantial proportion of patients, EFX treatment for 24 weeks was associated with normalization of liver fat and serum ALT, which appeared to underlie improvements in NASH histopathology. Thus, changes in NITs with EFX therapy can be extrapolated to predict improvement in liver histology, enabling noninvasive monitoring of EFX response among patients with moderate-to-advanced fibrosis and NASH.
- || BOS-580 / Boston Pharma, efruxifermin (AKR-001) / Amgen
Review, Journal: Fibroblast Growth Factor-21 as a Potential Therapeutic Target of Nonalcoholic Fatty Liver Disease. (Pubmed Central) - Jan 31, 2023
However, the definite effect of FGF-21 on NAFLD may be clarified after the completion of the ongoing clinical trials with paired liver biopsies and histological endpoints. The aim of this review is to critically summarize experimental and clinical data of FGF-21 in NAFLD, in an attempt to highlight existing knowledge and areas of uncertainty, and subsequently, to focus on the potential therapeutic effects of FGF-21 and its analogs in NAFLD.
- || efruxifermin (AKR-001) / Amgen
Clinical, P2a data, Journal: A randomized, double-blind, placebo-controlled phase IIa trial of efruxifermin for patients with compensated NASH cirrhosis. (Pubmed Central) - Jan 17, 2023
P2a
This proof-of-concept randomized, double-blind clinical trial demonstrated the potential therapeutic benefit of efruxifermin treatment compared to placebo in patients with cirrhosis due to NASH. NCT03976401.
- || efruxifermin (AKR-001) / Akero Therap
Enrollment closed: A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry) (clinicaltrials.gov) - Dec 27, 2022
P2b, N=200, Active, not recruiting, Sponsor: Akero Therapeutics, Inc
NCT03976401. Recruiting --> Active, not recruiting
- ||| efruxifermin (AKR-001) / Amgen
Clinical, P2b data: Stephen Harrison reports results of the HARMONY ph2b RCT of efruxifermin in #NASH. 128 pts randomised 1:1:1 to pbo, 28mg weekly or 50mg weekly for 96 weeks, 1ry endpoint readout at wk 24 #TLM22 (Twitter) - Nov 7, 2022
- efruxifermin (AKR-001) / Amgen
EFRUXIFERMIN, A BIVALENT FC-FGF21 ANALOG, DEMONSTRATES IMPROVED BIOPHYSICAL AND PHARMACOLOGICAL ENGAGEMENT WITH LIVE CELLS COMPARED TO MONOVALENT FGF21 ANALOGS () - Nov 2, 2022 - Abstract #AASLD2022AASLD_2439;
EFX's bivalent-FGF21 structure, with two RGE variants per molecule, results in much stronger affinity-predominantly because of more stable binding, i.e. slower dissociation-which translates into greater potency compared to the monovalent FGF21 analogs RGE and ¾ EFX. This is likely due to avidity effects due to bivalent EFX having more high- and low-affinity interactions with the surface of target cells than monovalent FGF21 analogs.
- efruxifermin (AKR-001) / Amgen
EFRUXIFERMIN (EFX) IN NONALCOHOLIC STEATOHEPATITIS WITH FIBROSIS: RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2b TRIAL (HARMONY) (Ballroom ABC) - Nov 2, 2022 - Abstract #AASLD2022AASLD_2394;
EFX significantly improved liver histology, LFC, and noninvasive markers of liver injury, fibrosis, and glucose and lipid metabolism in patients with F2/F3 fibrosis due to NASH. Both doses of EFX were generally well-tolerated, with mild-to-moderate GI events the most frequent AEs, and few AE-related study discontinuations.
- BFKB8488A / Roche, efruxifermin (AKR-001) / Amgen, pegozafermin (BIO89-100) / 89Bio
GREATER EFFICACY PREDICTED FOR FGFR1/BETA-KLOTHO RECEPTOR AGONISTS THAT ACHIEVE 60% OR GREATER INCREASES IN SERUM ADIPONECTIN () - Oct 23, 2022 - Abstract #AASLD2022AASLD_1297;
Greater treatment-induced adiponectin production likely mediates enhanced predicted efficacy with FGFR1/KLB agonists. Compounds and doses that achieve >60% increases in serum adiponectin are predicted to have greatest benefits in multiple NASH patient measurements.
- | efruxifermin (AKR-001) / Amgen
Was surprised by falcon studies and pegbelfermin. Especially as efruxifermin is reading out right now. (Twitter) - Oct 22, 2022
- |||| efruxifermin (AKR-001) / Amgen
Clinical: Very promising for efruxifermin (fgf21) in #NASH fibrosis. Some of the most impressive % improvement to date, alongside a low placebo rate. I look for forward to the larger 2b/3 trial, as let’s hope that the results are replicated #livertwitter @IanARowe @phil_newsome7 @EASLnews (Twitter) - Sep 14, 2022
- efruxifermin (AKR-001) / Amgen
Development and Validation of a Noncompetitive Immunoassay Optimized for the Assessment of Pharmacokinetics of Biologically Active Efruxifermin in Humans () - Jul 16, 2022 - Abstract #ENDO2022ENDO_1378;
Upon pre-study validation, the assay has met analytical performance criteria outlined in BMV regulatory guidances. We conclude the optimized ECLIA will be useful for reliable assessment of EFX PK in patients with NASH.
- || Review, Journal: Comprehensive Review and Updates on Holistic Approach Towards Non-Alcoholic Fatty Liver Disease Management with Cardiovascular Disease. (Pubmed Central) - Jun 30, 2022
Apart from discussing the results of late stage clinical trials and the possible challenges in managing these patients with limited approved therapies, we also discussed the specific management of comorbidities (diabetes, hypertension, hyperlipidaemia, cardiovascular diseases) in NAFLD patients. Treatment strategy needs to target improvements in liver-related outcomes and cardiometabolic profile.
- || efruxifermin (AKR-001) / Amgen
$AKRO Akero Therapeutics to Present at Keystone Symposium on Efruxifermin as a Therapy for NASH https://t.co/R3K89KwxV8 (Twitter) - Jun 13, 2022
- | efruxifermin (AKR-001) / Amgen
Preclinical, Journal: Efruxifermin, a long-acting Fc-fusion FGF21 analogue, reduces body weight gain but does not increase sympathetic tone or urine volume in Sprague Dawley rats. (Pubmed Central) - Apr 14, 2022
In contrast to at least one other FGF21 analogue, efruxifermin decreased rather than increased urine volume. The absence of an increase in sympathetic tone in rats mirrors the unchanged salivary cortisol and systemic blood pressure following efruxifermin treatment in humans.
- efruxifermin (AKR-001) / Amgen
Efx treatment improved histopathology and noninvasive markers of liver injury and fibrogenesis to a similar extent in NASH patients with high-risk PNPLA3 genotypes, compared to those with lowest genetic risk: a post-hoc analysis of balanced study (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1676;
1. Barrata et al.
- PF-05231023 / Pfizer, efruxifermin (AKR-001) / Amgen
Metabolic, biochemical, histopathological and transcriptomic effects of long-acting FGF21 analogue in the GAN diet-induced obese and biopsy-confirmed mouse model of NASH (Poster Area) - Mar 16, 2022 - Abstract #EASLILC2022EASL_ILC_1615;
Consistent with clinical findings, PF-05231023 improved NAS and Fibrosis Stage. These findings further validate clinical translatability of the GAN DIO-NASH mouse model.
- PF-05231023 / Pfizer, efruxifermin (AKR-001) / Amgen
METABOLIC, BIOCHEMICAL, HISTOLOGICAL, AND TRANSCRIPTOMIC EFFECTS OF A LONG-ACTING FGF- 21 ANALOGUE IN THE GAN DIET-INDUCED OBESE AND BIOPSY-CONFIRMED MOUSE MODEL OF NASH () - Mar 3, 2022 - Abstract #NASHTAG2022NASH_TAG_90;
Furthermore, PF-05231023 treatment improved clinical- derived endpoints for NAS and Fibrosis Stage. These findings highlight FGF21 as a promising therapeutic agent for fibrosing NASH and further validate clinical translatability of the GAN DIO-NASH mouse model.
- ||| efruxifermin (AKR-001) / Amgen
Trial completion, Trial completion date: A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 28, 2022
P2a, N=110, Completed, Sponsor: Akero Therapeutics, Inc
These findings highlight FGF21 as a promising therapeutic agent for fibrosing NASH and further validate clinical translatability of the GAN DIO-NASH mouse model. Active, not recruiting --> Completed | Trial completion date: Oct 2021 --> Jan 2022
- || efruxifermin (AKR-001) / Amgen
Enrollment closed, Trial primary completion date: Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Feb 14, 2022
P2b, N=128, Active, not recruiting, Sponsor: Akero Therapeutics, Inc
Active, not recruiting --> Completed | Trial completion date: Oct 2021 --> Jan 2022 Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2022 --> Jul 2022
- || Farxiga (dapagliflozin) / Ono Pharma, AstraZeneca
Clinical, Review, Journal: Non-Alcoholic Steatohepatitis (NASH) - A Review of a Crowded Clinical Landscape, Driven by a Complex Disease. (Pubmed Central) - Feb 2, 2022
At the time of writing this review, only Zydus Cadila's new drug application for Saroglitazar had been approved (2020) for NASH therapy in India...Obeticholic acid (Intercept Pharmaceuticals), Cenicriviroc (Allergan), Aramchol (Galmed Pharmaceuticals), Resmetirom (Madrigal Pharmaceuticals), Dapagliflozin and Semaglutide (Novo Nordisk) are in advanced Phase 3 clinical trials, while Belapectin (Galectin Therapeutics), MSDC-0602K (Cirius Therapeutics), Lanifibranor (Inventiva), Efruxifermin (Akero) and Tesamorelin (Theratechnologies) are expected to start Phase 3 trials soon...Hence, the development of a single therapy for NASH seems challenging and unlikely, despite the plethora of later stage trials due to report. We therefore predict that clinical, patient and company interest in pipeline and next-generation therapies will remain high for some time to come.
- |||| efruxifermin (AKR-001) / Amgen
@DrLoomba presenting on FGF21 trials in #NASH at #2022NASHTAG @NashTagConf Very promising data with Efruxifermin and Bio89 @akerotx @novonordisk @Duke_liverdoc @nagachalasani @anitakohli @LiverArizona (Twitter) - Jan 7, 2022
- | efruxifermin (AKR-001) / Amgen
Trial completion date: Harmony: A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - Nov 24, 2021
P2b, N=160, Recruiting, Sponsor: Akero Therapeutics, Inc
We therefore predict that clinical, patient and company interest in pipeline and next-generation therapies will remain high for some time to come. Trial completion date: Feb 2024 --> May 2024
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] CHARACTERIZATION OF HISTOLOGIC PATTERNS OF IMPROVEMENT FOLLOWING TREATMENT WITH EFRUXIFERMIN (EFX) IN NASH PATIENTS WITH FIBROSIS () - Oct 21, 2021 - Abstract #AASLD2021AASLD_2125;
Histologic patterns appeared to be correlated with serum markers of liver injury and glucose metabolism . Identification of improvement or regression patterns of NASH may be useful in assessing disease regression beyond NASH resolution and ≥1 stage improvement in fibrosis.
- efruxifermin (AKR-001) / Amgen
[VIRTUAL] Normalization of Liver Fat Following Treatment with Efruxifermin & Relationship with Histologic & Metabolic Improvements () - Oct 9, 2021 - Abstract #NASHSummitUS2021NASH_Summit_US_85;
Identification of improvement or regression patterns of NASH may be useful in assessing disease regression beyond NASH resolution and ≥1 stage improvement in fibrosis. Learning about the six-fold higher probability of NASH resolution with liver fat normalization Investigating the correlation between change in liver fat and decrease in markers of liver stress, injury, and restoration of metabolic health Analyzing the consistent improvements in fibrosis as assessed by serum markers, imaging, and histology in NASH patients with F1-F4 fibrosis