AKRO Akero Therapeutics Inc.

28.85
+0.07  (+0%)
Previous Close 28.78
Open 28.94
52 Week Low 10.78
52 Week High 41.16
Market Cap $1,001,725,228
Shares 34,721,845
Float 19,036,725
Enterprise Value $709,291,699
Volume 157,124
Av. Daily Volume 191,240
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Drug Stage Catalyst Date
AKR-001
Nonalcoholic steatohepatitis (NASH)
Phase 2a
Phase 2a
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Latest News

  1. Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will participate in a fireside chat at Evercore's 3rd Annual HealthCONx virtual conference at 11:20 a.m. ET on Thursday, December 3, 2020.

    A live webcast of the fireside chat and Q&A 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 for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic…

    Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will participate in a fireside chat at Evercore's 3rd Annual HealthCONx virtual conference at 11:20 a.m. ET on Thursday, December 3, 2020.

    A live webcast of the fireside chat and Q&A 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 for 30 days.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

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  2. Data to be presented at the Presidential Plenary Talk at The Liver Meeting®

    100% of patients in 50mg group demonstrated more than 50% relative reduction in liver fat

    50% of patients with F2/F3 fibrosis at baseline achieved two stage improvement in fibrosis score

    Type 2 diabetic patients showed improved glycemic control with HbA1c reduced by up to 0.9%

    Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced the presentation of additional data analysis from the Phase 2a BALANCED study at the Presidential Oral Plenary Session at The Liver Meeting®. The data continue to demonstrate the potential of efruxifermin (EFX) as a foundational monotherapy for patients with non-alcoholic steatohepatitis (NASH).

    Overall, the data show large magnitudes…

    Data to be presented at the Presidential Plenary Talk at The Liver Meeting®

    100% of patients in 50mg group demonstrated more than 50% relative reduction in liver fat

    50% of patients with F2/F3 fibrosis at baseline achieved two stage improvement in fibrosis score

    Type 2 diabetic patients showed improved glycemic control with HbA1c reduced by up to 0.9%

    Akero Therapeutics, Inc. (NASDAQ:AKRO) today announced the presentation of additional data analysis from the Phase 2a BALANCED study at the Presidential Oral Plenary Session at The Liver Meeting®. The data continue to demonstrate the potential of efruxifermin (EFX) as a foundational monotherapy for patients with non-alcoholic steatohepatitis (NASH).

    Overall, the data show large magnitudes of reduction in liver fat across all EFX dose groups with 100% of participants in the 50mg EFX dose group achieving more than 50% relative reduction in liver fat and 53% of patients in the same dose group achieving more than 70% relative reduction in liver fat.

    Among all EFX-treated patients who were fibrosis stage F2 or F3 at baseline (n=22), 50% experienced a two-stage improvement in fibrosis (n=11), while 68% experienced at least a one-stage improvement in fibrosis (n=15).

    Additional analysis of the BALANCED data showed substantial improvement in glycemic control for patients with both NASH and Type 2 diabetes, a group that comprises about half of all NASH patients. The company previously reported mean absolute reductions in HbA1c among all study participants of 0.1% for the 28mg dose, 0.4% (p<0.05) for the 50mg dose and 0.5% (p<0.01) for the 70mg dose. In patients with both NASH and Type 2 diabetes, researchers observed decreases of 0.6% in the 50mg dose and 0.9% (p<0.01) in the 70mg dose. Among EFX patients with NASH and Type 2 diabetes, the relative decreases in mean C-peptide levels ranged from 27 to 33% across EFX dose groups, compared to 22 to 29% for all EFX patients.

    "Additional analyses from the BALANCED study, including the proportion of subjects with at least 50 and 70% reductions in liver fat and the high proportion of subjects with F2/F3 fibrosis at baseline with fibrosis improvement, strengthens the potential of EFX to be truly transformative for people living with NASH, with improvements across multiple parameters for NASH and cardio-metabolic conditions," said Andrew Cheng, M.D., Ph.D., president and CEO of Akero. "With some of the strongest results reported to date in NASH, we eagerly anticipate the initiation of our adaptive Phase 2b/3 study of efruxifermin with hopes of improving lives of the more than 17 million Americans who are living with this disease."

    EFX has received European Medicines Agency Priority Medicines (PRIME) designation as a treatment for NASH. Akero plans to begin a Phase 2b/3 adaptive clinical trial in biopsy confirmed NASH patients in the first half of 2021. The company will be using 28mg and 50mg doses for that trial.

    Akero previously reported data from the BALANCED study demonstrating that each of the 28, 50 and 70mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12%, 13% and 14% of liver fat, respectively, compared with 0.3% for placebo, and relative reductions of 63%, 71% and 72% percent, compared to 0% for placebo. All of these results were highly statistically significant at p<0.001.

    Prior Reporting of secondary and exploratory endpoints revealed that of the 40 EFX treatment responders who had end-of-treatment biopsies, 48% achieved at least a one-stage improvement in fibrosis without worsening of NAFLD activity score (NAS) and 28% achieved at least a two-stage improvement in fibrosis. Additionally, 48% of responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss, were also observed across all dose groups. Treatment with EFX was generally reported to be well tolerated.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. NASH is a leading cause of liver transplants in the US and Europe.

    About the BALANCED Study

    The Phase 2a BALANCED study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult patients with NASH. The main study enrolled a total of 80 patients. Participants were randomized to receive weekly subcutaneous doses of efruxifermin (EFX), formerly known as AKR-001, or placebo for up to 16 weeks, with safety and tolerability followed through week 20. The primary efficacy endpoint for the study is absolute change from baseline in hepatic fat fraction measured by magnetic resonance imaging – proton density fat fraction (MRI-PDFF) at week 12. Secondary measures include change from baseline in ALT at 12 weeks, the number of patients who had a decrease of ≥2 points in the NAFLD activity score (NAS) at 24 weeks and safety and tolerability measures.

    About Efruxifermin

    Efruxifermin (EFX), formerly known as AKR-001, is Akero's lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. EFX is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. This holistic approach offers the potential to address the complex, multi-system disease state of NASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX offers convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance to improve overall health. The company's lead product candidate, Efruxifermin (EFX), formerly known as AKR-001, is currently being evaluated in an ongoing Phase 2a clinical trial. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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. Such statements include, but are not limited to, statements regarding: Akero's guidance regarding its business plans and objectives for EFX, including the therapeutic potential and clinical benefits thereof, as well as the safety and tolerability of EFX and future clinical development plans; Akero's Phase 2a BALANCED clinical trial, including its results and Akero's analysis of such results; Akero's design, implementation and expected timing of the Phase 2b/3 trial; the potential benefits conferred by the EMA on Akero's PRIME designation; and the potential impact of COVID-19 on patient retention, strategy, future operations and clinical trials.

    Any forward-looking statements in this statement 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 public health epidemics affecting countries or regions in which we have operations or do business, such as COVID-19, including potential negative impacts on Akero's employees, manufacturers, supply chain and production as well as on global economies and financial markets; the company'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 risks related to the competitive landscape. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Akero's actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in the company's 2019 Annual Report on Form 10-K filed with the United States 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 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.

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  3. SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today reported third quarter financial results for the period ending September 30, 2020.

    "On the heels of reporting strongly positive histological data from our FGF21 analog, efruxifermin (EFX), we executed a number of important objectives in the third quarter that position us for continued success," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "In addition to raising more than $216 million to enable continued development of EFX, we received feedback from the FDA that enables us to continue to pursue EFX development with our proposed adaptive Phase 2b/3 clinical trial design. EFX also received PRIME designation from EMA for development as a NASH therapy. Each of these milestones represents a large step forward in the development of EFX, which we believe has the potential to be a foundational monotherapy for NASH."

    Third Quarter Business Highlights

    • On July 10th, the Company closed an upsized underwritten public offering of 6,012,390 shares of common stock at a price of $36.00 per share. Gross proceeds from the offering, before deducting underwriting discounts, commissions and offering expenses, were approximately $216.4 million.
    • On July 21st, the Company announced publication of data in the journal Cell Reports Medicine from the Phase 1b clinical trial of EFX, which showed its potential to modulate biomarkers associated with metabolic diseases, including NASH.
    • On Sept. 24th, the Company announced that written guidance from the U.S. Food and Drug Administration (FDA) enables implementation of an innovative combined Phase 2b/3 study design for a pivotal EFX clinical trial in NASH patients with F2-F3 fibrosis. Under the planned adaptive trial design, the Company will evaluate the 28 and 50mg EFX doses in a 24-week Phase 2b portion of the trial to inform selection of one of these doses for evaluation in the Phase 3 portion of the study.
    • On Sept. 30th, the Company announced enrollment had been completed for a cohort of the BALANCED study (Cohort C), which is investigating the effects of 16 weeks of EFX treatment on patients with NASH who have compensated cirrhosis (F4), Child-Pugh Class A. The Company expects results from this study cohort to inform long-term development plans for EFX to treat cirrhotic NASH patients, who are at greatest risk of progressing to end-stage liver disease. The Company expects to report the results of the F4 expansion cohort in the first half of 2021.
    • On Oct. 16th, the Company announced that the European Medicines Agency (EMA) granted Priority Medicines (PRIME) designation to EFX for treatment of NASH. The designation was based on the positive efficacy data reported from the Company's Phase 2a BALANCED study. The PRIME program is designed to enhance regulatory support in the EU for the development of promising investigational medicines that target unmet medical need.

    Manufacturing Update

    • Manufacture of GMP drug substance (API) at commercial scale was completed in April 2020. GMP drug product for the Company's anticipated Phase 2b clinical trial was manufactured from this API in September 2020.
    • A new lyophilized formulation is being developed for commercial drug product. This formulation will be used for the Phase 3 portion of the adaptive clinical trial design. Scale-up of manufacturing for this new drug product formulation began during the third quarter of 2020 and is expected to be completed in 2022.

    Regulatory Update

    • Submission of multiple Investigational New Drug (IND) amendments are ongoing to support the Phase 2b portion of the adaptive Ph2b/3 study design. The Company remains on track to initiate Phase 2b in the first half of 2021.

    Financial Highlights

    • Akero's cash, cash equivalents and short-term marketable securities at September 30, 2020 were $291.9 million, which includes the net proceeds from the July 10th equity offering.
    • Research and development expenses for the three-month and nine-month periods ended September 30, 2020 were $17.4 million and $39.2 million, respectively, compared to $13.9 million and $23.9 million for the comparable periods in 2019. These increases are attributable to higher costs related to Akero's EFX program, including third-party contract manufacturing and contract research organization costs associated with the BALANCED study and internal personnel costs, including non-cash stock-based compensation.
    • General and administrative expenses for the three-month and nine-month periods ended September 30, 2020 were $4.2 million and $11.2 million, respectively, compared to $2.4 million and $5.5 million for the comparable periods in 2019. These increases are attributable to higher internal personnel costs, including non-cash stock-based compensation and professional services and other costs associated with operating as a public company.
    • Total operating expenses for the three-month and nine-month periods ended September 30, 2020, were $21.5 million and $50.4 million, respectively, compared to $16.3 million and $29.4 million for the comparable periods in 2019.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX has been shown to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverse fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week  Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.  

    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 the Company'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; the potential benefits resulting from the PRIME designation of EFX;  Akero's Phase 2a BALANCED study and Phase 2b/3 study including results and expected timing to complete Cohort C; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; expectations regarding successful scale-up of drug substance manufacturing and release of new drug product for use in clinical trials, including new product formulations; expectations regarding the Company's use of capital, expenses and other future financial results; statements regarding the timing of Company's efforts regarding the IND amendments; the Company's planned efforts to prepare for commercialization of EFX, if approved 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 the Company'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 the Company's product candidate development activities and planned clinical trials; the Company'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; the Company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 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.

    Akero Therapeutics, Inc.

    Condensed Consolidated Balance Sheets

    (Unaudited)

    (In thousands)







    September 30, 2020



    December 31, 2019

    Assets













    Cash and cash equivalents and short-term marketable securities



    $

    291,870



    $

    136,400

    Other current assets





    6,163





    1,649

    Non-current assets





    2,003





    69

    Total assets



    $

    300,036



    $

    138,118















    Liabilities and Stockholders' Equity













    Current liabilities



    $

    12,014



    $

    9,369

    Non-current liabilities





    1,564





    23

    Stockholders' equity





    286,458





    128,726

    Total liabilities and stockholders' equity



    $

    300,036



    $

    138,118

     

    Akero Therapeutics, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In thousands, except share and per share amounts)







    Three Months Ended September 30, 



    Nine Months Ended September 30, 





    2020



    2019



    2020



    2019

    Operating expenses:

























    Research and development



    $

    17,379



    $

    13,885



    $

    39,207



    $

    23,908

    General and administrative





    4,159





    2,424





    11,164





    5,522

    Total operating expenses





    21,538





    16,309





    50,371





    29,430

    Loss from operations





    (21,538)





    (16,309)





    (50,371)





    (29,430)

    Other income





    135





    755





    875





    1,286

    Net loss



    $

    (21,403)



    $

    (15,554)



    $

    (49,496)



    $

    (28,144)

    Comprehensive loss



    $

    (21,477)



    $

    (15,554)



    $

    (49,474)



    $

    (28,144)

    Net loss per common share, basic and diluted



    $

    (0.63)



    $

    (0.56)



    $

    (1.63)



    $

    (2.66)

    Weighted-average number of shares used in

    computing net loss per common share, basic and

    diluted





    34,002,769





    28,024,779





    30,381,671





    10,589,119

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akero-therapeutics-reports-third-quarter-2020-financial-results-301172303.html

    SOURCE Akero Therapeutics, Inc.

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  4. SOUTH SAN FRANCISCO, Calif., Oct. 21, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with non-alcoholic steatohepatitis (NASH) and other serious metabolic disorders, today announced that management will present at the following investor conferences next month:

    • 29th Annual Credit Suisse Healthcare Conference on Monday, November 9th at 1:15PM EST
    • Jefferies Global Healthcare Conference on Tuesday, November 17th at 1:45PM EST

    A live webcast of each presentation and Q&A will be available through the investor relations section of the Company's website at www.akerotx.com. Following the live webcasts, archived replays will be available on the Company's website.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/akero-therapeutics-to-present-at-upcoming-conferences-in-november-301157248.html

    SOURCE Akero Therapeutics, Inc.

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  5. SOUTH SAN FRANCISCO, Calif., Oct. 16, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational FGF21 analog for the treatment of NASH. The designation was granted based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study. Based on available published data, EFX is believed to be the first drug candidate to receive a PRIME designation for treatment of NASH.

    SOUTH SAN FRANCISCO, Calif., Oct. 16, 2020 /PRNewswire/ -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a cardio-metabolic non-alcoholic steatohepatitis (NASH) company developing pioneering medicines designed to restore metabolic balance and improve the overall health of NASH patients, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) designation to efruxifermin (EFX), an investigational FGF21 analog for the treatment of NASH. The designation was granted based on the positive efficacy data recently reported from the company's Phase 2a BALANCED study. Based on available published data, EFX is believed to be the first drug candidate to receive a PRIME designation for treatment of NASH.

    "We believe the EMA PRIME designation for efruxifermin provides important validation for the potential of EFX to become a foundational NASH monotherapy," said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. "This designation underscores not only the high level of unmet need for therapeutics to treat this life-threatening disease, but also EFX's potential to address multiple aspects of NASH and its associated comorbidities. We are grateful to the EMA for considering our application and for recognizing the potential benefits EFX could provide to patients, if approved."

    In reaching its decision, the EMA's Committee on Human Medicinal Products (CHMP) indicated preliminary 16-week data from Akero's Phase 2a clinical trial, the BALANCED study of EFX in biopsy-confirmed NASH patients, show EFX's potential to meet unmet medical need for NASH therapies by addressing multiple aspects of NASH-related morbidity and mortality. The CHMP also expressed that the totality of data, including histology data as well as biomarker data, together with better glycemic control and amelioration of dyslipidemia, suggest potential benefit not only for treatment of NASH but also the broader context of metabolic syndrome common in NASH patients.

    The BALANCED study, which evaluated EFX in treatment of biopsy-confirmed NASH patients for just 16 weeks, showed that 48% of all EFX-treated patients achieved at least a one-stage improvement in fibrosis without worsening of NASH, and 48% of all EFX patients achieved resolution of NASH without worsening of fibrosis. Patients treated with EFX also achieved relative reductions of liver fat ranging from 63-72% across three dose groups, compared to 0% for placebo. The study also showed that EFX improved multiple NASH comorbidities, including better glycemic control and improved lipoprotein profile as well as weight loss.

    The PRIME program is designed to enhance regulatory support in the EU for the development of promising investigational medicines that, based on early clinical data, may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. PRIME aims to provide multiple benefits so that these medicines can reach patients earlier: enhanced interaction and early dialogue with EMA, guidance on the overall development plan and regulatory strategy, and the potential for accelerated assessment of the marketing authorization application. For more information please visit the EMA website at www.ema.europa.eu.

    The company plans to initiate a Phase 2b/3 adaptive trial of EFX in biopsy-confirmed NASH patients in the first half of 2021 based on guidance received from the U.S. Food and Drug Administration.

    About NASH

    NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease) and is estimated to affect 17 million Americans and impacts more than a third of people with type 2 diabetes worldwide. NASH is closely linked to the obesity and diabetes epidemics seen around the world. NASH is characterized by an excessive accumulation of fat in the liver that causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer and eventually death. As a result, NASH has become a leading cause of liver transplants in the US and Europe.

    About Efruxifermin

    Efruxifermin (EFX), formerly AKR-001, is Akero's lead product candidate for NASH. EFX has been shown to increase insulin sensitivity, improve lipoproteins, reduce liver fat and inflammation, and reverses fibrosis. The breadth of desirable metabolic effects offers potential to address the complex, multi-organ/tissue pathogenesis of NASH, including risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Engineered to mimic the biological activity profile of native human FGF21, EFX offers convenient once-weekly dosing.

    About Akero Therapeutics

    Akero is a cardio-metabolic NASH company dedicated to reversing the escalating NASH epidemic by developing pioneering medicines designed to restore metabolic balance and improve overall health of NASH patients. The Company's lead product candidate, efruxifermin, has been evaluated in a 16-week Phase 2a clinical trial, the BALANCED study. Akero Therapeutics is headquartered in South San Francisco, CA. For more information, please visit www.akerotx.com.

    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 the Company'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; expectations regarding the design, implementation, timing, and success of its current and planned clinical trials for EFX; the PRIME designation of EFX, potential benefits resulting from such designation and related implications; and the potential impact of COVID-19 on strategy, future operations, 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 the Company'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 the Company's product candidate development activities and planned clinical trials; the Company'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; the Company's ability to fund operations; as well as those risks and uncertainties set forth more fully under the caption "Risk Factors" in Akero's Annual Report on Form 10-K for the year ended December 31, 2019 and most recently filed Quarterly Report on 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.

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    SOURCE Akero Therapeutics, Inc.

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