A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Compensated Cirrohosis Due to NASH/MASH

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.

Start Date04 Sep 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

CTIS2023-505141-48-00 / Recruiting

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/MetabolicDysfunction-Associated Steatohepatitis (MASH) and Fibrosis - AK-US-001-0105

Start Date15 Mar 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

CTRI/2023/11/060385 / RecruitingPhase 3

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH) And Fibrosis - NIL

Start Date06 Mar 2024

Sponsor / Collaborator

Akero Therapeutics, Inc.

100 Clinical Results associated with Efruxifermin

100 Translational Medicine associated with Efruxifermin

100 Patents (Medical) associated with Efruxifermin

Literatures (Medical) associated with Efruxifermin

01 Dec 2024·Environmental Pollution

Swine wastewater co-exposed with veterinary antibiotics enhanced the antibiotic resistance of endophytes in radish (Raphanus sativus L.)

Article

Author: Song, Chao ; White, Jason C. ; Chuan-Xin, Ma ; Chen, Chang-Er ; White, Jason C ; Gao, Fang-Zhou ; Ma, Chuan-Xin ; Jia, Wei-Li ; Ying, Guang-Guo

The widespread utilization of antibiotics in livestock has promoted the accumulation and diffusion of antibiotics and antibiotic resistance in agricultural soils and crops. Here we investigated the mechanisms of antibiotic uptake and accumulation in swine wastewater (SW)-treated radish (Raphanus sativus L.) and subsequent impacts on endophyte antibiotic resistance. Under SW treatments, exposure to 500 μg/L sulfamethazine (SMZ) and enrofloxacin (EFX) significantly affected radish biomass, with SMZ causing 63.0% increases and EFX causing 36.3% decreases relative to the untreated control. EFX uptake by radish were from 5 to 100-folds over SMZ. Passive diffusion through anion channel proteins on cell membranes was an important route for SMZ uptake, while both passive diffusion and energy-dependent processes contributed to the uptake of EFX. Bacterial community was time-dependent as a function of both antibiotics and SW, the bacterial alpha diversity in liquid solution co-treated with antibiotics and SW increased over time. The abundance of antibiotic resistance genes (ARGs) in the roots was positively correlated with ARGs in the Hoagland's solution under antibiotic-alone treatments. EFX co-exposure with SW enhanced the dissemination of ARGs from swine wastewater into plant roots, and significant correlations existed between ARGs and integrons in both Hoagland's solution and roots. These findings increased our understanding of the fate of antibiotics in crops and their subsequent impacts on antibiotic resistance of endophytic bacteria.

01 Jul 2024·Clinical Pharmacology & Therapeutics

Efficacy and Safety of Fibroblast Growth Factor‐21 Analogs for the Treatment of Metabolic Dysfunction‐Associated Steatohepatitis: A Systematic Review and Meta‐Analysis

Review

Author: Baek, In‐hwan ; Jeon, Nakyung ; Han, Nayoung ; Jeong, Changhyeon ; Rhee, Su‐jin ; Kim, Min‐Soo ; Staatz, Christine E.

Fibroblast growth factor (FGF)‐21 analogs are potential therapeutic candidates for metabolic dysfunction‐associated steatohepatitis (MASH). This systematic review and meta‐analysis aimed to assess the efficacy and safety of the FGF‐21 analogs, efruxifermin, pegbelfermin, and pegozafermin for MASH treatment. A comprehensive systematic review and meta‐analysis of randomized controlled trials from five major databases was conducted. Primary efficacy outcomes focused on liver histological improvement, while secondary efficacy outcomes encompassed reductions in liver fat content and improvements in biochemical parameters. Safety outcomes examined included treatment‐emergent adverse events (TEAEs), treatment‐related TEAEs, TEAEs leading to discontinuation, and serious TEAEs. Eight eligible studies involving 963 patients were included in this review. Compared with the placebo group, the FGF‐21 analog‐treated group exhibited significantly improved primary efficacy outcomes, specifically ≥1 stage improvement in fibrosis with no worsening of MASH (risk ratio [RR] = 1.83; 95% confidence interval [CI] = 1.27–2.62) and at least two‐point improvement in the non‐alcoholic fatty liver disease activity score with no worsening of fibrosis (RR = 2.85; 95% CI = 2.06–3.95). Despite an increased risk of TEAEs (RR = 1.17; 95% CI = 1.08–1.27) and treatment‐related adverse events (RR = 1.75; 95% CI = 1.40–2.19), FGF‐21 analogs exhibited an acceptable safety profile. 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.

01 Jul 2024·Journal of Gastroenterology and Hepatology

Efficacy of pharmacologic interventions on magnetic resonance imaging biomarkers in patients with nonalcoholic fatty liver disease: systematic review and network meta‐analysis

Review

Author: Liakos, Aris ; Sarakapina, Anna ; Malandris, Konstantinos ; Bekiari, Eleni ; Papandreou, Stylianos ; Giouleme, Olga ; Kakotrichi, Panagiota ; Karagiannis, Thomas ; Kalopitas, Georgios ; Iatridi, Fotini ; Sinakos, Emmanouil ; Paschos, Paschalis ; Tsapas, Apostolos ; Vasilakou, Despoina

AbstractBackground and AimSeveral agents are under investigation for nonalcoholic fatty liver disease (NAFLD). We assessed the comparative efficacy of pharmacologic interventions for patients with NAFLD focusing on magnetic resonance imaging (MRI) biomarkers.MethodsWe searched Medline, Embase, and CENTRAL. We included randomized controlled trials of more than 12 weeks of intervention that recruited patients with biopsy‐confirmed or MRI‐confirmed NAFLD and assessed the efficacy of interventions on liver fat content (LFC) and fibrosis by means of MRI. We performed random‐effects frequentist network meta‐analyses and assessed confidence in our estimates using the CINeMA (Confidence in Network Meta‐Analysis) approach.ResultsWe included 47 trials (8583 patients). Versus placebo, thiazolidinediones were the most efficacious for the absolute change in LFC, followed by vitamin E, fibroblast growth factor (FGF) analogs, and glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) with mean differences ranging from −7.46% (95% confidence interval [−11.0, −3.9]) to −4.36% (−7.2, −1.5). No differences between drug classes were evident. Patients receiving GLP‐1 RAs or glucose‐dependent insulinotropic polypeptide (GIP)/GLP‐1 RAs were more likely to achieve ≥30% relative reduction in LFC. Among agents, efruxifermin produced the largest reduction in LFC compared to placebo [−13.5% (−18.5, −8.5)], followed by pioglitazone, while being superior to most interventions. The effect of interventions on magnetic resonance elastography assessed fibrosis was small and insignificant. The confidence in our estimates was low to very low.ConclusionsSeveral 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.

126

News (Medical) associated with Efruxifermin

21 Oct 2024

·www.globenewswire.com

Akero Therapeutics to Present Data Reinforcing the Efficacy of Efruxifermin at the 75th Annual AASLD The Liver Meeting® 2024

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced an upcoming oral presentation and two late-breaking poster presentations at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® 2024 taking place from November 15-19, 2024, in San Diego. The presentations will highlight findings from the 96-week Phase 2b HARMONY study evaluating the efficacy and safety of lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3), along with insights from an analysis using AI and digital-based pathology. Details for the presentations are as follows: Title: Efruxifermin Significantly Improved Liver Fibrosis at Week 96 in the HARMONY Study Across Subgroups and Improvements Were Associated With Changes in Biomarkers Presenter: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute Date/Time: Sunday, November 17, 2024, from 2:00 PM – 2:15 PM PST Publication Number: 158 Oral Session: MASLD and MASH – New Therapies Title: Efruxifermin significantly reduced proportion of subjects with at-risk MASH and led to near-complete histological disease reversal at week 96 in the HARMONY study Presenter: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute Date/Time: Monday, November 18, 2024, from 8:00 AM – 5:00 PM PST Publication Number: 5021 Session: Late Breaking Posters Title: AI and digital-based pathology corroborate reduction in fibrosis observed by conventional pathology with efruxifermin treatment of patients with F2-F3 MASH in the HARMONY study Presenter: Mazen Noureddin, M.D., M.H.Sc., Professor of Medicine, Houston Methodist Hospital and Director, Houston Research Institute Date/Time: Monday, November 18, 2024, from 8:00 AM – 5:00 PM PST Publication Number: 5047 Session: Late Breaking Posters About Akero Therapeutics Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH or compensated cirrhosis due to MASH: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. The SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY study in patients with compensated cirrhosis due to MASH (F4) in which patients have been treated for up to 96 weeks. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information. Investor Contact:Christina TartagliaPrecision AQ212.362.1200christina.tartaglia@precisionaq.com Media Contact:Peg RusconiDeerfield GroupPeg.rusconi@deerfieldgroup.com

Phase 2

01 Oct 2024

·www.prnewswire.com

INVESTOR ACTION NOTICE: Moore Law PLLC Encourages Investors in Akero Therapeutics, Inc. to Contact Law Firm

NEW YORK, Sept. 30, 2024 /PRNewswire/ -- Moore Law, PLLC, a shareholder litigation law firm located on Wall Street, is investigating potential claims against: Akero Therapeutics, Inc. ("Akero") (NASDAQ:AKRO) Shareholders should email [email protected]; please contact only if shares acquired before September 13, 2022 The investigation concerns misrepresentations to investors as to the true nature of the patient population that was being tested in Akero's SYMMETRY study. Specifically, despite telling investors that the study's patient population was limited to those with NASH induced cirrhosis (a fact that was key for data integrity and the likelihood of study success), for approximately 20% of those being tested Akero had not confirmed that the patients had NASH and that NASH had in fact caused their cirrhosis. Akero shocked the market on October 10, 2023 when the company posted disappointing interim data from its Phase 2b SYMMETRY trial for EFX. Specifically, Akero stated that 22% (28mg) and 24% (50mg) of those on EFX and 14% on placebo indicated at least one stage improvement in fibrosis with no worsening of NASH at week 36, the trial's primary endpoint, but that these changes were not statistically significant. In addition, Akero added that 12 patients, including 11 in EFX groups, discontinued the trial due to drug-related adverse events. On this news, Akero's stock price fell $30.39 per share, or 62.61%, to close at $18.15 per share on October 10, 2023. If you own Akero Therapeutics, Inc. ("Akero") (NASDAQ:AKRO), please contact Fletcher Moore by email at [email protected] or (212) 709-8245. ABOUT MOORE LAW PLLC Moore Law is a NYC plaintiff litigation law firm for investors. We hold officers and directors accountable for breaches of fiduciary duty, fraud, insider trading, wasteful spending, and other corporate malfeasance. There is no cost to you. Our investor cases are contingency only. Fletcher Moore, Esq. Moore Law, PLLC [email protected] SOURCE Moore Law PLLC WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical Result

30 Sep 2024

·www.globenewswire.com

Akero Therapeutics to Present at the H.C. Wainwright 8th Annual MASH Virtual Conference

SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, today announced that management will participate in a fireside chat at the H.C. Wainwright 8th Annual MASH Virtual Conference on Monday, October 7, 2024, at 11:00 a.m. E.T. A live webcast of the Company presentation will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcast, an archived replay will be available on the Company's website. About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including MASH. Akero's lead product candidate, EFX, is currently being evaluated in the ongoing SYMMETRY study, a 96-week Phase 2b clinical trial in patients with compensated cirrhosis due to MASH (F4 fibrosis), as well as three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH or compensated cirrhosis due to MASH: SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes. The SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the SYMMETRY study in patients with compensated cirrhosis due to MASH (F4) in which patients have been treated for up to 96 weeks. Akero is headquartered in South San Francisco. Visit us at akerotx.com and follow us on LinkedIn and X for more information. Investor Contact:Christina TartagliaPrecision AQ212.362.1200christina.tartaglia@precisionaq.com Media Contact:Peg Rusconi617.910.6217peg.rusconi@deerfieldgroup.com

Phase 2

100 Deals associated with Efruxifermin

External Link

KEGG	Wiki	ATC	Drug Bank
D11868	-	-	-

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Nonalcoholic fatty liver	Phase 3	AU	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	CH	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	AR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	KR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	US	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	TR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	CA	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	IL	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	PR	Akero Therapeutics, Inc.	10 Nov 2023
Nonalcoholic fatty liver	Phase 3	IN	Akero Therapeutics, Inc.	10 Nov 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04767529 (HARMONY, Corporate Publications) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	128	efruxifermin 28mg (Primary Analysis)	(bnolbmcdhj) = fgdyiywtzr scdzmmjfsk (lkoearvwpv ) View more	Positive	04 Mar 2024
				efruxifermin 50mg (Primary Analysis)	(bnolbmcdhj) = mygzzvcpoh scdzmmjfsk (lkoearvwpv ) View more
NCT05039450 (AK-US-001-0103, Pubmed) Manual	Phase 2	Diabetes Mellitus, Type 2 \| Nonalcoholic Steatohepatitis	31	Efruxifermin 50 mg+GLP-1 Receptor Agonist	(jpewmkxxwb) = The addition of efruxifermin to a GLP-1RA appeared safe and well-tolerated. The most frequent efruxifermin-related adverse events were mild to moderate gastrointestinal events. pcgtqyyfse (fdtfhuczwf )	Positive	01 Mar 2024
				Placebo+GLP-1 Receptor Agonist
NCT04767529 (HARMONY, Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 2	Nonalcoholic Steatohepatitis	128	Efruxifermin 28 mg	(kdoqmrsoiw) = rarldubdgu tpgpomykle (qrgwxtrdvm ) View more	Positive	01 Dec 2023
				Efruxifermin 50 mg	(kdoqmrsoiw) = xthmdijizz tpgpomykle (qrgwxtrdvm ) View more
NCT05039450 (SYMMETRY, Corporate Publications) Manual	Phase 2	Nonalcoholic Steatohepatitis	182	Efruxifermin 28 mg	(xfafmjdvhk) = cnvriynzbb uwoyslalfy (irjztqrxhk ) View more	Negative	10 Oct 2023
				Efruxifermin 50 mg	(xfafmjdvhk) = rqjmyqznhn uwoyslalfy (irjztqrxhk ) View more
NCT03976401 (Pubmed)	Phase 2	Nonalcoholic Steatohepatitis \| Fibrosis	30	Efruxifermin 50 mg	(auhmyzfhrd) = Significant improvements were noted in key markers of liver injury (alanine aminotransferase) and glucose and lipid metabolism eeaiiuakjc (cvdzhdrgwl )	-	01 Jan 2023
				Placebo
BALANCED study (EASL2021)	Phase 2	Fibrosis \| Fatty Liver \| Liver Injury	80	Efruxifermin	atwhdqbfmj(aextzrhter): Odds Ratio = 4.083 (95% CI, 1.122 - 14.863), P-Value = 0.0365 View more	-	23 Jun 2021
				Placebo

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