AKRO Akero Therapeutics Inc.

21.44
-0.2  -1%
Previous Close 21.64
Open 21.55
52 Week Low 20.46
52 Week High 37.94
Market Cap $746,671,112
Shares 34,826,078
Float 21,988,326
Enterprise Value $505,456,327
Volume 241,609
Av. Daily Volume 235,876
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Upcoming Catalysts

Drug Stage Catalyst Date
Efruxifermin (Harmony)
Nonalcoholic Steatohepatitis
Phase 2b
Phase 2b
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Drug Pipeline

Drug Stage Notes
Efruxifermin
Nonalcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
Phase 2a Cohort C data announced March 22, 2021. 25% of EFX patients (3 of 12) showed NASH resolution. 4 of 12 patients (33%) achieved a one-stage improvement in fibrosis without worsening of NASH. Further data released at EASL meeting June 2021.

Latest News

  1. SOUTH SAN FRANCISCO, Calif., July 14, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the appointment of Judy Chou, Ph.D., to its board of directors as an independent director.

    "Dr. Chou's expertise in biomanufacturing and protein therapeutic development and experience managing regulatory filings and commercial launches make her an asset to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "Akero is fortunate to welcome Dr. Chou and benefit from her strategic insights, particularly as our investigational NASH drug efruxifermin progresses…

    SOUTH SAN FRANCISCO, Calif., July 14, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced the appointment of Judy Chou, Ph.D., to its board of directors as an independent director.

    "Dr. Chou's expertise in biomanufacturing and protein therapeutic development and experience managing regulatory filings and commercial launches make her an asset to our Board," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero Therapeutics. "Akero is fortunate to welcome Dr. Chou and benefit from her strategic insights, particularly as our investigational NASH drug efruxifermin progresses in the clinic."

    Judy Chou, Ph.D., is a biotech industry leader with a 25-year track record of driving drug development and biomanufacturing successes in established and emerging growth biopharmaceutical companies. Dr. Chou is currently President & CEO of AltruBio, Inc., a company focused on developing novel therapeutics for immunological diseases. Prior to AltruBio, she was senior vice president and global head of Biotech at Bayer Pharmaceuticals where she oversaw a more than $3 billion biotechnology product portfolio and led drug development and launch activities for the companies' biologics pipeline. Earlier in her career, Dr. Chou held senior pharmaceutical operations and manufacturing roles at Pfizer, Inc., formerly Medivation, and Tanvex Biopharma, Inc. Before joining the industry, Dr. Chou was a research faculty member at Harvard University Medical School, focused on cell biology and neuroscience research. She received her Ph.D. from Yale University and completed her post-doctoral training at Max-Planck Institute in Germany.

    "Akero's rapid progress advancing a differentiated and potentially best-in-class medicine capable of reversing the effects of NASH and restoring liver health is inspiring and compelling," said Dr. Chou. "I look forward to working with Akero's leadership team to guide this novel therapy through the clinic and, if efruxifermin is approved, to introduce it to patients and families."

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    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 or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; Akero's Phase 2b HARMONY clinical trial; and its growth as a company and the anticipated contribution of the members of our board of directors to our operations and progress. 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: risks related to the impact of COVID-19 on Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the 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.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    650.487.6488



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  2. SOUTH SAN FRANCISCO, Calif., July 08, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine.

    The manuscript, available at this link, provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with Akero's investigational drug, efruxifermin (EFX), an FGF21 analog, achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis…

    SOUTH SAN FRANCISCO, Calif., July 08, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced that full results of the main portion of its Phase 2a BALANCED trial in biopsy-confirmed NASH patients with F1-F3 fibrosis have been published in Nature Medicine.

    The manuscript, available at this link, provides a comprehensive analysis showing that pre-cirrhotic NASH patients treated for 16 weeks with Akero's investigational drug, efruxifermin (EFX), an FGF21 analog, achieved substantial reductions in liver fat, associated with decreases in markers of liver injury and inflammation, and reversal of fibrosis after only 16 weeks treatment. Numerous endpoints are reported for the first time in Nature Medicine.

    "This disclosure of EFX data in Nature Medicine marks the first published clinical evidence of fibrosis regression with an FGF21 analog and what we believe are the largest reductions in liver fat publicly reported to date across all NASH investigational drug classes," said Kitty Yale, chief development officer of Akero. "We're pleased to contribute to the field of NASH clinical research with publication of these data. We extend gratitude to the trial participants who made this study possible."

    NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. An estimated 17.3 million Americans had NASH in 2016, a number that is expected to increase to 27.0 million by 2030. There are currently no approved therapies for NASH. Weight loss of 10 percent or more has been shown to reverse NASH by restoring normal levels of liver fat and reducing insulin resistance. Unfortunately, achieving this degree of weight loss through lifestyle change is very challenging.

    "The holy grail for NASH drug development is a therapy that treats the whole person, addressing liver fat accumulation, insulin resistance, and liver cell stress that drive the disease, as well as reducing inflammation, and reversing fibrosis," said Stephen Harrison, MD, medical director of Pinnacle Clinical Research and lead author. "The magnitude and consistency of positive effects in all of these areas demonstrate potential for EFX to be a foundational NASH monotherapy."

    The BALANCED study was a randomized, controlled Phase 2a trial across 27 U.S. sites that enrolled 80 biopsy-confirmed, pre-cirrhotic NASH patients (F1 to F3 fibrosis stage) who received either placebo or EFX for 16 weeks as a weekly subcutaneous injection in one of three doses: 28 mg, 50 mg, or 70 mg. The study met its primary endpoint of absolute change from baseline in hepatic fat fraction measured at week 12, with 48 percent of EFX patients across dose groups achieving normal levels of liver fat (defined as less than 5 percent liver fat), compared with 5 percent of placebo patients. Reductions in liver fat were associated with substantial decreases in markers of liver injury and fibrosis. Consistent with these observations, 50 percent of EFX patients who had F2/F3 fibrosis at baseline and repeat biopsies after 16 weeks of treatment achieved a two-stage regression of fibrosis. Reflecting EFX's potential to have a beneficial impact on whole body metabolism, EFX patients were reported to have significantly improved levels of triglyceride, non HDL-cholesterol and HbA1c, along with a trend toward lower body weight.

    EFX was reported to be generally well tolerated. There were two Serious Adverse Events, one of which occurred prior to dosing, and there were no deaths in the study. Across EFX groups, the most frequent AEs were grade 1 or 2 gastrointestinal events, which were transient in nature.

    The BALANCED study also incorporated a 30-patient expansion cohort in late-stage (F4) cirrhotic NASH. Substantial improvements in fibrosis were evident after 16 weeks of treatment among patients with end-of-treatment biopsies, with 58 percent of EFX patients meeting one of two key biopsy endpoints. Specifically, 4 of 12 patients who received 50mg EFX achieved a one-stage improvement in fibrosis without worsening of NASH1 and 3 of 12 achieved NASH resolution2, in each case compared with 0 of 5 placebo patients. The expansion cohort data are not included in the Nature Medicine publication and will be submitted for potential publication in the future. Topline results are reported here.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. EFX is designed to offer convenient once-weekly subcutaneous dosing. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    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 or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial; and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. 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: risks related to the impact of COVID-19 on Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the 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.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    650.487.6488

    ______________________________

    1 No worsening of NASH mean no increase in NAFLD Activity Score (NAS) for ballooning, inflammation, or steatosis.

    2 NASH resolution is defined as having a NAS of 0 or 1 for lobular inflammation and a score of 0 for ballooning, out of a total possible NAS of 8 (0-3 for steatosis, 0-3 for lobular inflammation, and 0-2 for hepatocyte ballooning).



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  3. SOUTH SAN FRANCISCO, Calif., June 25, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which are being presented by Juan Frias, MD, medical director of the National Cancer Institute, as two posters at the American Diabetes Association's 81st Scientific Sessions (ADA). The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the company's website. The company's EFX program in NASH is also being featured in a video presentation at the ADA, which can…

    SOUTH SAN FRANCISCO, Calif., June 25, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which are being presented by Juan Frias, MD, medical director of the National Cancer Institute, as two posters at the American Diabetes Association's 81st Scientific Sessions (ADA). The posters are available starting at 11:30am ET on June 25, 2021 and will be posted to the company's website. The company's EFX program in NASH is also being featured in a video presentation at the ADA, which can be accessed from the company's website.

    In a poster presentation titled "Efruxifermin is associated with improved glucose metabolism in patients with NASH and type 2 diabetes" (Abstract 116-LB), Dr. Frias reports improvements in markers of glucose metabolism, insulin sensitivity and lipoprotein profile, with a trend to reduce body weight, in patients with NASH and type 2 diabetes mellitus after 16 weeks of treatment with EFX. These improvements, including a clinically meaningful and statistically significant reduction in HbA1c, were seen on top of concomitant anti-diabetic medications.

    "Improving insulin sensitivity and glucose metabolism is a critical component in the management of NASH because metabolic dysregulation plays a major role in the pathophysiology of this disorder, and because roughly one third of patients with type 2 diabetes also have NASH—often with suboptimal glycemic control," said Dr. Frias. "These preliminary data demonstrating improvements in glucose metabolism with EFX are very encouraging and indicate that EFX may play an important future role in the management of NASH in patients with glucose intolerance."

    In a second poster presentation titled "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" (Abstract 119-LB), Dr. Frias reports the contribution of FGFR1c activation by EFX in adipose tissue, as indicated by increased serum adiponectin, to the beneficial effects observed on liver health and glucose metabolism. These secondary analyses highlight the potential of FGFR1c-mediated reprogramming of adipose metabolism in NASH patients to improve liver health. Insulin-sensitizing therapeutics acting predominantly on adipose tissue, such as pioglitazone, have historically been associated with weight gain. A consistent trend toward weight loss in the BALANCED study suggests that EFX may redirect fat away from the liver to adipose tissue in a weight-neutral manner, contributing to the potentially unique therapeutic profile of EFX.   

    "The only way to really treat NASH is to treat the whole body and not just the liver," said Tim Rolph, chief scientific officer of Akero Therapeutics. "The breadth, consistency and magnitude of effects observed following treatment with EFX across clinical trials in patients with metabolic disease appear to derive from EFX's balanced agonism of FGF21's receptors in adipose tissue and liver."

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. In prior clinical trials, EFX has reversed fibrosis, resolved NASH, reduced liver fat, improved glycemic control, improved lipoprotein profile, and shown a trend to lower body weight. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    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 or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial; and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. 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: risks related to the impact of COVID-19 on Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the 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.

    Investor Contact:

    Christina Tartaglia

    212.362.1200

    Media Contact:

    650.487.6488

     



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  4. SOUTH SAN FRANCISCO, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which were presented in two posters at the 2021 International Liver Congress. These analyses show significant correlations between normalization of liver fat (≤ 5% liver fat content (LFC) by MRI-PDFF) and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism. The new analyses also show that combining ALT response of ≥ 17 U/L with normalization of liver fat increases…

    SOUTH SAN FRANCISCO, Calif., June 21, 2021 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic biotechnology company developing transformational treatments for non-alcoholic steatohepatitis (NASH), today announced additional analyses from its Phase 2a BALANCED study of efruxifermin (EFX) in NASH patients with F1-F3 fibrosis, which were presented in two posters at the 2021 International Liver Congress. These analyses show significant correlations between normalization of liver fat (≤ 5% liver fat content (LFC) by MRI-PDFF) and improvements in markers of liver injury and fibrosis, as well as whole-body metabolism. The new analyses also show that combining ALT response of ≥ 17 U/L with normalization of liver fat increases the power to predict resolution of NASH (0- or 1-point for lobular inflammation and 0 points for ballooning component of NAFLD Activity Score) and NASH resolution combined with a 1-stage improvement in fibrosis.

    • Abstract No. 1314: "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," presented by Rohit Loomba, M.D.
    • Abstract No. 1762: "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," presented by Stephen Harrison, M.D.

    "These analyses provide evidence that rapid and substantial liver fat reduction was associated with improvements in markers of liver metabolic health and improvement of NASH histopathology following treatment with efruxifermin," said Kitty Yale, chief development officer of Akero. "These analyses also make an important contribution toward the development of noninvasive markers that can predict histological improvements in NASH. Based on the strength of these correlations, as well as biopsy results from the BALANCED study, we believe treatment with EFX will result in sustained histological improvements in our ongoing and future clinical trials."

    Extent of Reduction of Liver Fat Content (LFC) at Week 12

    EndpointPlaceboa28mg EFX50mg EFX70mg EFX
     Relative Reduction in LFC
     ≥50%5%69%**100%***93%***
     ≥70%5%50%*53%**80%***
     Normalization of LFC
     ≤5% at Week 125%25%*53%**67%***

    *p<0.05, **p<0.01, ***p<0.001

    a A single placebo responder lost 25 pounds over 16 weeks (11% weight reduction)

    Summary of Key Odds Ratios for Liver Fat Normalizationa

    Histologic EndpointOdds Ratio (95% CI)bP valuec
     NASH Resolution14.1 (1.2, 13.2)0.0365
     NAS Reduction by ≥426.4 (1.8, 15.6)0.0068

    a ≤5% Liver Fat Content at Week 12; b Wald 95% Confidence Interval; cFisher's exact test;

    1 0- or 1-point for lobular inflammation and 0 points for ballooning components of NAFLD Activity Score

    2 At least 2 points in lobular inflammation and/or ballooning components of NAFLD Activity Score

    Summary of Key AUROC for Predicting Histological Response Among ALT Respondersa

    Histologic EndpointALT Responders (N=28)ALT Responders with ≤ 5%

    Liver Fat Content (N=16)
     NASH Resolution0.74 (0.56, 0.93)0.83 (0.61, 1)
     NASH Resolution and Fibrosis Improvement of ≥1 Stage0.62 (0.39, 0.86)0.79 (0.90, 70.2)

    a Among Patients with available MRI-PDFF and ALT change at Week 12, and end-of-treatment biopsy (N=54)

    "EFX is the first therapy to have shown at least a 70 percent relative reduction in liver fat in a majority of all patients evaluated, and normalization of liver fat in approximately half of all patients evaluated," said Stephen Harrison, MD, medical director of Pinnacle Clinical Research. "These analyses showing that large reductions or normalization of liver fat correlate with improvements in multiple non-invasive markers and histopathology of NASH suggest the potential of EFX to set a new threshold for magnitude of liver fat reduction and associated removal of the underlying driver of NASH."

    EFX is currently being evaluated in a Phase 2b clinical trial in patients with F2/F3 fibrosis, the HARMONY study. A second Phase 2b clinical trial in patients with Cirrhotic (F4) NASH is planned for the second half of 2021.

    About Akero Therapeutics

    Akero Therapeutics is a clinical-stage cardio-metabolic company developing transformational treatments for non-alcoholic steatohepatitis (NASH), a disease without any approved therapies. Akero's lead product candidate, efruxifermin (EFX) is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that alleviates cellular stress and regulates metabolism throughout the body. In prior clinical trials, EFX has reversed fibrosis, resolved NASH, reduced liver fat, improved glycemic control, improved lipoprotein profile, and reduced body weight. The consistency and magnitude of observed effects position EFX to be a potentially best-in-class medicine, if approved, for treatment of NASH. EFX is currently being evaluated in a Phase 2b clinical trial in NASH patients with F2/F3 fibrosis, the HARMONY study. Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.

    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 or expectations for EFX, upcoming milestones, and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; Akero's Phase 2a BALANCED clinical trial, including additional analysis of its data and potential therapeutic benefits; Akero's Phase 2b HARMONY clinical trial, including expected timing to complete enrollment and report preliminary results; and the potential impact of COVID-19 on strategy, future operations, enrollment and clinical trials. 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: risks related to the impact of COVID-19 on Akero's ongoing and future operations, including potential negative impacts on Akero's employees, third-parties, manufacturers, supply chain and production as well as on global economies and financial markets; 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, as filed with the Securities and Exchange Commission (SEC) and quarterly reports on Form 10-Q filed with the 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.



    Investor Contact:
    Christina Tartaglia
    212.362.1200
    
    
    Media Contact:
    650.487.6488
    

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  5. - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics…

    - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.

    "We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.

    "Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."

    "We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."

    "Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."

    Sidley Austin LLP served as legal adviser to venBio.

    About venBio

    Established in 2011, venBio is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception in 2011, venBio has raised nearly $1.5 billion in capital commitments and led investment rounds in 34 companies, including: venBio-founded Labrys Biologics (acquired by Teva) and ALX Oncology (NASDAQ:ALXO); Aragon Pharmaceuticals (acquired by Johnson & Johnson); Seragon Pharmaceuticals (acquired by Roche); Aurinia Pharmaceuticals (NASDAQ:AUPH); Apellis Pharmaceuticals (NASDAQ:APLS); Turning Point Therapeutics (NASDAQ:TPTX); Precision Biosciences (NASDAQ:DTIL); Akero Therapeutics (NASDAQ:AKRO); Harmony Biosciences (NASDAQ:HRMY); and Pharvaris (NASDAQ:PHVS). For more information, please visit www.venbio.com.

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