share_log

Akero Therapeutics Reports Positive Results for Efruxifermin in Treating Metabolic Dysfunction-Associated Steatohepatitis at AASLD Liver Meeting 2024

Akero Therapeutics Reports Positive Results for Efruxifermin in Treating Metabolic Dysfunction-Associated Steatohepatitis at AASLD Liver Meeting 2024

akero therapeutics报告称,Efruxifermin在治疗代谢紊乱相关脂肪肝炎方面取得积极成果,该成果在2024年AASLD肝脏大会上公布。
Quiver Quantitative ·  2024/11/16 00:12

Over 40% of EFX 50mg participants experienced liver fibrosis regression after 96 weeks, demonstrating significant clinical efficacy.

超过40%的EFX 50mg参与者在96周后出现肝纤维化逆转,显示出显著的临床疗效。

Quiver AI Summary

Quiver AI 概要

Akero Therapeutics announced promising results from its clinical trial of efruxifermin (EFX) for treating metabolic dysfunction-associated steatohepatitis (MASH), presented at the 75th Annual AASLD Meeting. Over 40% of participants receiving EFX 50mg for 96 weeks showed regression of liver fibrosis through various established measures, contrasting with 0% in the placebo group. Additionally, 30% of those on EFX experienced near-complete reversal of MASH-related disease. Analysis using AI-based digital pathology supported conventional histopathology findings, showing significant improvements in liver fibrosis. The results demonstrate EFX's potential to be a differentiated therapy for MASH, with ongoing Phase 3 trials aiming to confirm its safety and efficacy.

akero therapeutics宣布其用于治疗代谢功能障碍相关脂肪肝炎(MASH)的efruxifermin(EFX)临床试验的初步结果,并在第75届AASLD年会上进行了展示。超过40%的接受EFX 50mg治疗96周的参与者通过多项已建立的指标显示肝纤维化逆转,而安慰剂组则无任何参与者表现出这种改善。此外,30%的EFX治疗者经历了MASH相关疾病的近乎完全逆转。基于人工智能的数字病理分析支持了传统组织病理学的发现,显示肝纤维化有显著改善。这些结果表明EFX有潜力成为治疗MASH的差异化治疗,正在进行的3期试验旨在确认其安全性和有效性。

Potential Positives

潜在的积极因素

  • Over 40% of participants treated with EFX 50mg for 96 weeks showed significant regression of liver fibrosis, highlighting the treatment's efficacy compared to placebo where no participants showed such improvement.
  • 30% of participants receiving EFX 50mg experienced almost complete reversal of MASH-related disease, indicating a substantial therapeutic benefit that is not observed in the placebo group.
  • Data analyses support positive clinical outcomes with consistent improvement across multiple established markers of liver health, reinforcing EFX's potential as a differentiated therapy for MASH.
  • 在接受EFX 50mg治疗96周的参与者中,超过40%显示出肝纤维化显著逆转,突显出该治疗相较于安慰剂的有效性,后者没有参与者表现出这样的改善。
  • 30%的接受EFX 50mg治疗的参与者经历了几乎完全的MASH相关疾病逆转,表明有显著的治疗益处,而在安慰剂组未观察到此情况。
  • 数据分析支持了积极的临床结果,并在多个已建立的肝健康指标上持续改善,进一步强化了EFX作为MASH差异化治疗的潜力。

Potential Negatives

潜在负面影响

  • Despite promising results, the press release relies heavily on clinical data from a Phase 2b study, which may not guarantee the same level of success in larger Phase 3 trials, introducing uncertainty regarding the efficacy and approval of EFX.
  • The company does not provide details about any adverse effects experienced by participants during the trial, raising concerns about the safety profile of EFX despite claims of a generally favorable safety outcome.
  • There is an implication of risk regarding regulatory developments and future market approvals due to the inclusion of multiple forward-looking statements, which indicates the potential for negative outcomes that could impact the company's future performance.
  • 尽管结果令人鼓舞,但新闻稿主要依赖于一项20亿阶段研究的临床数据,这可能无法保证在更大规模的3期试验中获得同样的成功,从而引入了EFX的有效性和批准的不确定性。
  • 公司没有提供关于参与者在试验期间经历的任何不良反应的细节,这引发了对EFX安全性特征的担忧,尽管声称整体安全结果令人满意。
  • 由于包含多个前瞻性声明,因此暗示了关于监管动态和未来市场批准的风险,这表明可能会出现负面结果,从而影响公司的未来表现。

FAQ

FAQ

What are the primary findings of the EFX treatment study?

EFX治疗研究的主要发现是什么?

Over 40% of participants treated with EFX 50mg showed significant regression in liver fibrosis after 96 weeks compared to placebo.

与安慰剂相比,接受EFX 50mg治疗的参与者中超过40%在96周后显示出肝纤维化显著回退。

How does EFX impact liver fibrosis in patients with MASH?

EFX对MASH患者的肝纤维化有何影响?

EFX treatment led to clinically meaningful improvements in liver fibrosis and a notable reduction in liver stiffness and serum biomarkers.

EFX治疗在肝纤维化方面带来了临床意义上的改善,并显著降低了肝脏硬度和血清生物标志物。

What percentage of participants achieved complete disease reversal with EFX?

使用EFX的参与者中,有多少百分比实现了完全的疾病逆转?

30% of participants treated with EFX 50mg experienced almost complete reversal of MASH-related disease after 96 weeks.

接受50mg EFX治疗的30%参与者在96周后几乎完全逆转了与MASH相关的疾病。

What is the significance of AI-based pathology in the study?

基于人工智能的病理在研究中有什么重要性?

AI-based digital pathology corroborated the improvements in liver fibrosis observed with conventional histopathology throughout the treatment period.

基于人工智能的数字病理与整个治疗期间观察到的常规组织学在肝纤维化改善方面相一致。

What are the implications of these EFX treatment results?

这些EFX治疗结果有什么影响?

The results suggest EFX has potential as a differentiated therapy for patients with pre-cirrhotic MASH based on substantial clinical effects.

结果表明,EFX在基于显著的临床效果的情况下,对患有前肝硬化MASH的患者具有作为差异化治疗的潜力。

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

免责声明:这是由GlobeNewswire分发的新闻稿的人工智能生成摘要。用于总结这份稿件的模型可能会出错。请在这里查看完整发布。


$AKRO Insider Trading Activity

$AKRO 内部交易活动

$AKRO insiders have traded $AKRO stock on the open market 52 times in the past 6 months. Of those trades, 0 have been purchases and 52 have been sales.

$AKRO内部联系人过去6个月在公开市场上交易了$AKRO股票52次。在这些交易中,没有购买,只有52次销售。

Here's a breakdown of recent trading of $AKRO stock by insiders over the last 6 months:

以下是过去6个月内部联系人对$AKRO股票最近交易的详细信息:

  • CATRIONA YALE (Chief Development Officer) has traded it 15 times. They made 0 purchases and 15 sales, selling 83,316 shares.
  • ANDREW CHENG (President and CEO) has traded it 8 times. They made 0 purchases and 8 sales, selling 209,632 shares.
  • JONATHAN YOUNG (Chief Operating Officer) has traded it 13 times. They made 0 purchases and 13 sales, selling 123,800 shares.
  • TIMOTHY ROLPH (Chief Scientific Officer) has traded it 2 times. They made 0 purchases and 2 sales, selling 2,917 shares.
  • WILLIAM RICHARD WHITE (Chief Financial Officer) has traded it 13 times. They made 0 purchases and 13 sales, selling 298,470 shares.
  • PATRICK LAMY (Senior VP, Commercial Strategy) sold 569 shares.
  • CATRIONA YALE (首席发展官) 共交易了15次。他们没有购买,进行了15次销售,卖出了83,316股。
  • ANDREW CHENG (总裁兼首席执行官) 共交易了8次。他们没有购买,进行了8次销售,卖出了209,632股。
  • JONATHAN YOUNG (首席运营官) 共交易了13次。他们没有购买,进行了13次销售,卖出了123,800股。
  • TIMOTHY ROLPH (首席科学官) 共交易了2次。他们没有购买,进行了2次销售,卖出了2,917股。
  • WILLIAm RICHARD WHITE (首席财务官) 共交易了13次。他们没有购买,进行了13次销售,卖出了298,470股。
  • PATRICk LAMY (高级副总裁,商业策略) 卖出了569股。

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

要跟踪内部交易,请查看Quiver Quantitative的内部交易特斯拉-仪表。

$AKRO Hedge Fund Activity

$AKRO对冲基金活动

We have seen 77 institutional investors add shares of $AKRO stock to their portfolio, and 100 decrease their positions in their most recent quarter.

我们看到77家机构投资者在最近一个季度增加了$AKRO股票的持仓,100家则减少了他们的持仓。

Here are some of the largest recent moves:

以下是一些最近最大的交易动态:

  • WELLINGTON MANAGEMENT GROUP LLP added 2,782,029 shares (+54.4%) to their portfolio in Q3 2024
  • FRED ALGER MANAGEMENT, LLC removed 1,213,093 shares (-90.7%) from their portfolio in Q2 2024
  • BRAIDWELL LP added 1,084,400 shares (+inf%) to their portfolio in Q2 2024
  • JANUS HENDERSON GROUP PLC added 754,283 shares (+12.3%) to their portfolio in Q2 2024
  • DEEP TRACK CAPITAL, LP added 689,784 shares (+inf%) to their portfolio in Q3 2024
  • YIHENG CAPITAL MANAGEMENT, L.P. removed 675,410 shares (-47.1%) from their portfolio in Q3 2024
  • MILLENNIUM MANAGEMENT LLC removed 622,984 shares (-78.6%) from their portfolio in Q2 2024
  • WELLINGTON MANAGEMENt GROUP LLP在2024年第三季度新增了2,782,029股(+54.4%)的股票。
  • FRED ALGER MANAGEMENt, LLC在2024年第二季度减持了1,213,093股(-90.7%)的股票。
  • BRAIDWELL LP在2024年第二季度新增了1,084,400股(+inf%)的股票。
  • JANUS HENDERSON GROUP PLC在2024年第二季度新增了754,283股(+12.3%)的股票。
  • DEEP TRACk CAPITAL, LP 在2024年第三季度增加了689,784股(+inf%)到他们的投资组合
  • YIHENG CAPITAL MANAGEMENt, L.P. 在2024年第三季度从他们的投资组合中移除了675,410股(-47.1%)
  • MILLENNIUm MANAGEMENt LLC 在2024年第二季度从他们的投资组合中移除了622,984股(-78.6%)

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

要追踪对冲基金的股票组合,请查看Quiver Quantitative的机构持股仪表板。

Full Release

全面发布




-- Over 40% of participants treated with EFX 50mg for 96 weeks, compared with 0% for placebo, showed regression of liver fibrosis by all of three orthogonal measures: (1) ≥1-stage fibrosis improvement by NASH-CRN stage (conventional histopathology), (2) 30% reduction of liver stiffness by FibroScan







(imaging fibrosis biomarker), and (3) 0.5 point decrease in ELF



TM



score (serum fibrosis biomarker) –



-- 超过40%的参与者在接受96周的50mg EFX治疗后,肝纤维化在所有三种正交测量方式中均显示回归,与安慰剂组的0%相比:(1) NASH-CRN阶段下≥1级纤维化改善(常规组织病理学),(2) FibroScan检测显示肝脏硬度降低30%







(影像学纤维化生物标志物),以及(3) ELF评分减少0.5分



是有资格参加FORTITUDE-OLE



score (serum fibrosis biomarker) –




-- Analysis of biopsies by AI-based Digital Pathology (qFibrosis



, Histoindex) corroborated the extent of improvement in fibrosis observed with conventional histopathology after 24 and 96 weeks of EFX treatment, including statistically significant reductions in fibrosis within the perisinusoidal and periportal zones of the liver –



-- Analysis of biopsies by AI-based Digital Pathology (qFibrosis



, Histoindex) corroborated the extent of improvement in fibrosis observed with conventional histopathology after 24 and 96 weeks of EFX treatment, including statistically significant reductions in fibrosis within the perisinusoidal and periportal zones of the liver –




-- 30% of participants receiving EFX 50mg for 96 weeks, compared to 0% for placebo, had almost complete reversal of MASH-related disease, as indicated by reversal of fibrosis to F≤1, resolution of steatohepatitis, and normalization of fat content to ≤5%



-- 30%的参与者在接受96周EFX 50mg治疗后几乎完全逆转了与MASH有关的疾病,这表现在纤维化逆转至F≤1,脂肪肝炎消退,以及脂肪含量正常化至≤5%–



SOUTH SAN FRANCISCO, Calif., Nov. 15, 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 results of analyses supporting the clinical activity of efruxifermin (EFX) in metabolic dysfunction-associated steatohepatitis (MASH) in one oral presentation and two late-breaking poster presentations at the 75

th

Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting





, held November 15-19, 2024, in San Diego.


SOUTH SAN FRANCISCO, Calif., Nov. 15, 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 results of analyses supporting the clinical activity of efruxifermin (EFX) in metabolic dysfunction-associated steatohepatitis (MASH) in one oral presentation and two late-breaking poster presentations at the 75



Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting





, held November 15-19, 2024, in San Diego.



"The data to be presented at The Liver Meeting





show that 96 weeks of treatment with EFX has the potential to drive substantial reversal of disease in patients living with pre-cirrhotic MASH," said Kitty Yale, chief development officer of Akero. "We are encouraged by consistent improvements observed across a number of clinically established markers of liver health and the corroboration of conventional histopathology assessments with Artificial Intelligence (AI)-based digital pathology. We believe these new analyses provide further evidence for the potential of EFX to be a differentiated therapy for MASH."


"The data to be presented at The Liver Meeting





show that 96 weeks of treatment with EFX has the potential to drive substantial reversal of disease in patients living with pre-cirrhotic MASH," said Kitty Yale, chief development officer of Akero. "We are encouraged by consistent improvements observed across a number of clinically established markers of liver health and the corroboration of conventional histopathology assessments with Artificial Intelligence (AI)-based digital pathology. We believe these new analyses provide further evidence for the potential of EFX to be a differentiated therapy for MASH."



An oral presentation will highlight findings from the completed 96-week Phase 2b HARMONY study in patients with pre-cirrhotic MASH, fibrosis stages F2-F3. These findings include assessment of liver biopsies by conventional histopathology and AI-based digital pathology, as well as analyses of individual participants' responses across clinically established measures of liver fibrosis:


一次口头报告将重点突出关于完成的96周相位20亿HARMONY研究的发现,该研究对象为肝硬化前MASH患者,纤维化阶段F2-F3。这些发现包括通过传统组织病理学和基于AI的数字病理学对肝脏活检的评估,以及对个体参与者在临床确立的肝纤维化测量中的反应分析:



  • AI-based digital pathology scoring of fibrosis (by HistoIndex, using their proprietary qFibrosis scoring) corroborated the EFX-associated histopathologic improvements scored by per-protocol consensus reads, and highlighted statistically significant EFX-associated reductions in qFibrosis



    in both the perisinusoidal and periportal zones of the liver after 24 and 96 weeks of treatment.

  • In addition, analysis of changes in multi-modal, non-invasive markers of liver fibrosis among individual participants showed that:

    • More than half of individuals treated with EFX 50mg experienced clinically meaningful reductions in

      both

      widely used non-invasive tests of fibrosis (liver stiffness by FibroScan



      vibration-controlled transient elastrography [VCTE] and Enhanced Liver Fibrosis [ELF

      TM

      ] Test), approximately nine-fold the rate of placebo.

    • Over 40% of individuals treated with EFX 50mg for 96 weeks experienced improved fibrosis by conventional histopathology,


      as well as


      clinically meaningful improvements in imaging (liver stiffness by FibroScan



      ) and serum (ELF

      TM

      score) biomarkers of liver fibrosis, compared with 0% of individuals on placebo.

    • The proportion of individuals who responded to EFX 28 mg was smaller than that for EFX 50mg based on these same measures:


  • AI-based digital pathology scoring of fibrosis (by HistoIndex, using their proprietary qFibrosis scoring) corroborated the EFX-associated histopathologic improvements scored by per-protocol consensus reads, and highlighted statistically significant EFX-associated reductions in qFibrosis



    in both the perisinusoidal and periportal zones of the liver after 24 and 96 weeks of treatment.

  • In addition, analysis of changes in multi-modal, non-invasive markers of liver fibrosis among individual participants showed that:

    • More than half of individuals treated with EFX 50mg experienced clinically meaningful reductions in

      这两个

      广泛使用的非侵入性纤维化检测(通过FibroScan检测肝脏硬度



      振动控制瞬态弹性成像[VCTE]和增强型肝纤维化[ELF

      是有资格参加FORTITUDE-OLE

      )测试,约为安慰剂的九倍。

    • 超过40%的接受EFX 50mg治疗96周的个体根据传统组织病理学检测到纤维化改善,


      以及


      在影像学(通过FibroScan检测肝脏硬度)上获得临床意义的改善,



      以及血清(ELF)

      是有资格参加FORTITUDE-OLE

      分数)肝纤维化的生物标志物,与0%接受安慰剂的个体相比。

    • 响应EFX 28毫克的个体比例小于响应EFX 50毫克的比例,这基于相同的测量标准:




Proportions of Participants with Improved Liver Fibrosis as Indicated by Congruence of Improvements in Non-Invasive Markers of Fibrosis


and Conventional Histopathology After EFX Treatment



改善肝纤维化的参与者比例,依据非侵入性纤维化标记物改善的一致性


以及EFX治疗后常规组织病理学















































Responder Type (Proportion of Participants)



1




Placebo


(N=32)



EFX 28mg


(N=26)



EFX 50mg


(N=24)



ELF



TM


(≥0.5 absolute reduction in score)

25

%

58

%

71

%


Liver Stiffness

(≥30% relative reduction by FibroScan



VCTE)

19

%

50

%

71

%


ELF



TM



+ Liver Stiffness


6

%

38

%

54

%


ELF



TM



+ Liver Stiffness + Histopathology



2



0

%

19

%

42

%


应答者类型(参与者比例)



1




安慰剂


(N=32)



EFX 28毫克


Movement Disorders



EFX 50毫克


(N=24)



e.l.f. beauty



是有资格参加FORTITUDE-OLE


(≥0.5分数的绝对减少)

25

%

58

%

71

%


肝脏硬度

(≥30% 相对减少通过FibroScan)



VCTE)

19

%

50

%

71

%


e.l.f. beauty



是有资格参加FORTITUDE-OLE



+ 肝脏硬度


6

%

38

%

54

%


e.l.f. beauty



是有资格参加FORTITUDE-OLE



+ 肝脏硬度 + 组织病理学



2



0

%

19

%

42

%



1

Based on those patients with baseline and Week 96 measurements of ELF

TM

score, liver stiffness (FibroScan



), and conventional histopathology

2

Fibrosis improvement ≥1 stage without MASH worsening, by conventional histopathology



1

基于那些在基线和第96周ELF测量的患者

是有资格参加FORTITUDE-OLE

评分、肝硬度(FibroScan



)和常规组织病理学

2

纤维化改善≥1级,且未伴随MASH恶化,通过常规组织学检查



One poster (#5047) presents an orthogonal analysis of baseline, week 24, and week 96 liver biopsies from HARMONY by HistoIndex. This analysis corroborates the pattern of anti-fibrotic effects observed with conventional pathology after treatment with EFX for 24 or 96 weeks. Specifically, a quantitative analysis by qFibrosis



across different zones of the liver revealed EFX-associated reductions in fibrosis primarily in the perisinusoidal and periportal zones that were sustained or expanded from weeks 24 through 96 for participants, regardless of baseline fibrosis stage.


一张海报(#5047)展示了HARMONY研究中HistoIndex对基线、24周和96周肝活检的正交分析。这项分析支持了在接受EFX治疗24或96周后,常规病理学观察到的抗纤维化作用模式。具体而言,通过qFibrosis进行的定量分析



揭示EFX相关的纤维化减少主要发生在窦周和门户区,且这种减少在24周至96周的参与者中保持或扩大,无论基线纤维化阶段如何。



The second poster (#5021) presentation shows that 30% of participants receiving EFX 50mg for 96 weeks had almost complete reversal of MASH-related disease, as indicated by reversal of fibrosis to F≤1, resolution of MASH, and normalization of liver fat content to ≤5%, compared to 0% of participants on placebo. In addition, 100% of participants who received EFX 50mg for 96 weeks were categorized as "low risk of progressive MASH" (i.e., MASH with F≥2, NAS≥4) by FibroScan



-AST (FAST) score. In contrast, 48% of participants receiving placebo remained at high or indeterminate risk of progressive MASH. Based on the same analyses, the extent of reversal of disease relative to placebo was smaller for participants receiving EFX 28mg than 50mg.


第二张海报(#5021)展示的结果显示,接受EFX 50mg治疗96周的参与者中有30%几乎完全逆转了与MASH相关的疾病,表现为纤维化逆转至F≤1、MASH的缓解,以及肝脏脂肪含量规范化至≤5%,相比之下,安慰剂组参与者则为0%。此外,接受EFX 50mg治疗96周的参与者中有100%被评估为“低风险进展MASH”(即MASH伴F≥2,NAS≥4),基于FibroScan



-ASt (FAST)评分。相对而言,48%接受安慰剂的参与者仍然处于高风险或不确定风险的进展MASH状态。根据相同的分析,接受EFX 28mg治疗的参与者相对于安慰剂的疾病逆转程度小于50mg组。



"We believe that, taken together, the suite of presentations provides evidence supporting the consistent anti-fibrotic effects of EFX observed to date in the HARMONY trial as well as the the clinical activity and generally favorable safety profile of EFX in patients with precirrhotic MASH (F2-F3). The ongoing Phase 3 SYNCHRONY program is designed to confirm a favorable benefit-risk profile and support marketing applications for EFX for the treatment of MASH," said Ms. Yale.


"我们相信,综合所有展示的内容提供证据,支持在HARMONY试验中观察到的EFX一致的抗纤维化效果,以及EFX在具有前肝硬化MASH(F2-F3)患者中的临床活性和总体良好的安全性。如今进行的第三阶段SYNCHRONY项目旨在确认EFX的有利获益风险特征,并为EFX在MASH治疗中的批准申请提供支持,"耶尔女士说道。



Details for the presentations are as follows:


演讲详情如下:




Title:

Efruxifermin Significantly Improved Liver Fibrosis at Week 96 in the HARMONY Study Across Subgroups and Improvements Were Associated With Changes in Biomarkers

Speaker:

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



职称:

在HARMONY研究中,Efruxifermin在第96周显著改善了不同亚组的肝纤维化,改善与生物标志物的变化相关。

发言人:

Mazen Noureddin万.D.万.H.Sc.,医学教授,休斯顿卫理公会医院,休斯顿研究院董事。

日期/时间:

2024年11月17日,星期日,下午2:00 - 下午2:15 PST

出版编号:

158

口头报告:

MASLD和MASH – 新疗法




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



职称:

人工智能和数字化病理与传统病理相辅相成,证实了在HARMONY研究中,对F2-F3 MASH患者进行efruxifermin治疗时观察到的纤维化减轻。

报告人:

Mazen Noureddin万.D.万.H.Sc.,休斯顿卫理公会医院内科教授及休斯顿研究所董事。

日期/时间:

2024年11月18日,星期一,太平洋标准时间上午8:00 – 下午5:00

出版编号:

5047

会议主题:

最新突破海报




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



职称:

Efruxifermin显著减少了有风险的MASH受试者比例,并在HARMONY研究第96周几乎完全逆转了组织学疾病

报告人:

Mazen Noureddin万.D.万.H.Sc.,医学教授,休斯顿卫理公会医院及休斯顿研究院主任

日期/时间:

2024年11月18日,星期一,太平洋标准时间上午8:00至下午5:00

出版编号:

5021

会议主题:

最新突破海报




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 three ongoing Phase 3 clinical trials in patients with pre-cirrhotic MASH (F2-F3) or compensated cirrhosis (F4) 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 completed HARMONY study in patients with pre-cirrhotic MASH (F2-F3) and the ongoing SYMMETRY study in patients with compensated cirrhosis (F4) due to MASH, in which more than 300 patients have been treated with EFX or placebo 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.



关于akero therapeutics

akero therapeutics是一家临床阶段公司,专注于开发变革性疗法,以满足重度代谢疾病患者的紧迫医疗需求,包括MASH。akero的首选产品候选EFX目前正在对三项正在进行的III期临床试验进行评估,参与者为患有前肝硬化MASH(F2-F3)或因MASH导致的代偿性肝硬化(F4)的患者:同步SYNCHRONY。

组织

, SYNCHRONY

真实世界研究的患者是患有MASH(F1-F3纤维化)或MASLD的患者。

, 以及SYNCHRONY

研究是针对患有因MASH(F4纤维化)引起的代偿性肝硬化患者进行的SYNCHRONY

. SYNCHRONY项目基于两个20亿阶段临床试验的结果,该试验在患有前肝硬化MASH (F2-F3) 的患者中完成的HARMONY研究,以及在由于MASH导致的代偿性肝硬化 (F4) 患者中进行的SYMMETRY研究,已有超过300名患者接受了EFX或安慰剂治疗,持续时间最长可达96周。akero therapeutics总部位于南旧金山。请访问我们

akerotx.com

并关注我们

LinkedIn



X

此链接。




Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding Akero's business plans and objectives, including future plans orexpectations for EFX and its potential differentiated profile; the therapeutic effects of EFX; as well as the dosing, clinical activity,safety and tolerability of EFX. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Akero's product candidate development activities and planned clinical trials; Akero's ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; Akero's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in Akero's other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Akero undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



前瞻性声明

本新闻稿中关于非历史性事实事项的声明为1995年《私人证券诉讼改革法》所指的“前瞻性陈述”。由于此类陈述存在风险和不确定性,实际结果可能与此类前瞻性陈述所表达或暗示的结果存在重大差异,包括但不限于,关于akero therapeutics的业务计划和目标的陈述,包括对EFX及其潜在差异化特征的未来计划或期望;EFX的治疗效果;以及EFX的剂量、临床活性、安全性和耐受性。本新闻稿中任何前瞻性陈述均基于管理层对未来事件的当前预期,并受到一系列风险和不确定性的影响,这些风险和不确定性可能导致实际结果与此类前瞻性陈述所设定或暗示的结果存在显著不利差异。导致前瞻性陈述的不确定性特征的风险包括:akero therapeutics的产品候选开发活动和计划临床试验的成功、成本和时间安排;akero therapeutics执行其策略的能力;临床研究的积极结果不一定能预测未来或正在进行的临床研究的结果;美国及其他国家的监管动态;akero therapeutics资助运营的能力;以及在akero therapeutics最近提交给证券交易委员会(SEC)的10-k表格年度报告和10-Q表格季度报告中的“风险因素”标题下更详细列出的风险和不确定性,以及akero therapeutics与SEC其他文件和报告中讨论的潜在风险、不确定性和其他重要因素。所有包含在本新闻稿中的前瞻性陈述仅在作出时有效。akero therapeutics没有义务更新此类陈述以反映作出日期后发生的事件或存在的情况。




Investor Contact:

Christina Tartaglia
Precision AQ
212.362.1200
christina.tartaglia@precisionaq.com



投资者联系人:

Christina Tartaglia
Josh.Rappaport@precisionaq.com
Amanda Sellers
christina.tartaglia@precisionaq.com




Media Contact:

Peg Rusconi
Deerfield Group
Peg.rusconi@deerfieldgroup.com



媒体联系:

Peg Rusconi
迪尔菲尔德集团
Peg.rusconi@deerfieldgroup.com



声明:本内容仅用作提供资讯及教育之目的,不构成对任何特定投资或投资策略的推荐或认可。 更多信息
    抢沙发