Latest news with #SYMMETRY
Yahoo
20-05-2025
- Business
- Yahoo
Akero Therapeutics Announces Publication of Phase 2b SYMMETRY Trial in the New England Journal of Medicine
Results support potential benefit of efruxifermin (EFX) to elicit fibrosis improvement in patients with compensated cirrhosis (F4 fibrosis) due to MASH 96-week data from SYMMETRY trial presented at EASL Congress 2025 SOUTH SAN FRANCISCO, Calif., May 09, 2025 (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 publication of results from the Phase 2b SYMMETRY trial in the New England Journal of Medicine. The publication reports results from the 96-week SYMMETRY study evaluating the efficacy and safety of Akero's lead FGF21 analog efruxifermin (EFX), in participants with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, caused by metabolic dysfunction-associated steatohepatitis (MASH). 'Publication of the Phase 2b SYMMETRY trial results in the New England Journal of Medicine is a significant milestone that affirms the strength of our clinical data and the potentially transformative nature of EFX in the treatment of patients with compensated cirrhosis due to MASH,' said Kitty Yale, chief development officer of Akero. 'We remain encouraged by the potential benefits of treatment with EFX observed in the study, including unprecedented fibrosis improvement in patients with compensated cirrhosis due to MASH after 96 weeks of treatment, and look forward to continuing advancement of our ongoing Phase 3 SYNCHRONY program.' The primary endpoint was ≥1-stage fibrosis improvement without MASH worsening at 36 weeks of treatment, with secondary outcomes of fibrosis improvement without MASH worsening at week 96 and MASH resolution at weeks 36 and 96. Using an intent-to-treat (ITT) analysis of the 36 week results, for which participants with missing biopsies were included as non-responders, 19% of participants in the EFX 50mg group and 18% of participants in the EFX 28mg group met the primary endpoint, compared to 13% for placebo. At week 96, using the same ITT analysis, 29% of participants in the EFX 50mg group and 21% of participants in the EFX 28mg group had fibrosis improvement without MASH worsening, compared to 11% in the placebo group. Most participants in the EFX groups with a fibrosis improvement at week 36 appeared to maintain their response at week 96, with additional new responders observed at week 96, particularly for the EFX 50mg group. EFX was also associated with improvements in noninvasive markers of liver injury and fibrosis, as well as markers of insulin sensitivity and lipid metabolism compared with placebo at week 96. The safety and tolerability of EFX observed in the SYMMETRY trial was consistent with previous trials. Observed adverse events, more common with EFX than placebo, were primarily gastrointestinal (e.g., diarrhea and nausea) or injection site related, with the majority being mild or moderate and transient in nature. About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, efruxifermin (EFX), is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic (F2-F3 fibrosis) MASH, SYNCHRONY Outcomes in patients with compensated cirrhosis (F4) due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (metabolic dysfunction-associated steatotic liver disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. About MASHMASH is a serious form of MASLD that is estimated to affect 17 million Americans. MASH 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. Approximately 20% of patients with MASH will progress to cirrhosis, which has a higher risk of mortality. There are no approved treatments for the condition and MASH is the fastest growing cause of liver transplants and liver cancer in the US and Europe. About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer, and death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe. About the SYMMETRY Trial SYMMETRY was a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study randomized 182 patients, and 181 received once-weekly subcutaneous EFX 28mg or 50mg, or placebo for 96 weeks. The primary efficacy endpoint was the proportion of patients with ≥1-stage fibrosis improvement without worsening of MASH at Week 36. Secondary efficacy measures at Week 96 included ≥1 stage fibrosis improvement without worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, serum markers of glucose and lipid metabolism, as well as safety and tolerability measures. About EFXEfruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. 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; the potential transformative nature and therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; the future potential and long-term benefits of EFX following the preliminary topline week 96 results of Akero's Phase 2b SYMMETRY study; and the ongoing SYNCHRONY Phase 3 program,. 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 any of its clinical studies 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. Investor Contact:Christina TartagliaPrecision Media Contact:Peg RusconiDeerfield in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
24-03-2025
- Business
- Associated Press
Notice to Long-Term Shareholders of Akero Therapeutics, Inc. (Nasdaq: AKRO); Driven Brands Holdings, Inc. (Nasdaq: DRVN); Integra Lifesciences Holdings Corporation (Nasdaq: IART); and Kyverna Therapeutics, Inc. (Nasdaq: KYTX): Grabar Law Office is Investigating Claims on Your Behalf
PHILADELPHIA, March 24, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ: AKRO): Grabar Law Office is investigating whether certain officers and directors of Akero breached their fiduciary duties owed to the company. If you have held Akero Therapeutics, Inc. (NASDAQ: AKRO) shares since prior to September 13, 2022, you can seek corporate reforms, the return of money back to the company, and a court approved monetary award at no cost to you whatsoever. You are encouraged to learn more about the investigation and your rights by visiting You can also contact Joshua Grabar at [email protected] or call 267-507-6085. WHY: A recently filed underlying securities fraud class action Complaint alleges that Akero Therapeutics, via certain of its officers and directors, made false and/or misleading statements and/or failed to disclose to the investing public that: (i) approximately 20% of the patients enrolled in its SYMMETRY study had cryptogenic cirrhosis and did not have definitive NASH at baseline; (ii) the cryptogenic cirrhotic patients included in the SYMMETRY study did not have biopsy-proven compensated cirrhosis due to definitive NASH; (iii) the results from the cryptogenic cirrhosis patients were to be excluded from the calculation of the NASH resolution secondary endpoints; (iv) Akero had introduced a confounding factor into the SYMMETRY study's design, materially influencing the study's potential results and increasing the risks that the study would fail to meet its primary endpoint; (v) the SYMMETRY study did not align with U.S. Food & Drug Administration guidance for testing a drug in treating NASH cirrhotics because Akero had not ruled out potential causes of each patient's cirrhosis other than NASH; and (vi) consequently, Akero had materially misrepresented the nature of the SYMMETRY trial, its usefulness in supporting any new drug application, the likelihood that the SYMMETRY trial would be successful as measured by its primary endpoint, and the likelihood that EFX would become a commercial treatment for NASH cirrhotics. WHAT YOU CAN DO NOW: Current Akero shareholders who have held Akero shares since on or before September 13, 2022, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them whatsoever. If you would like to learn more about this matter, please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085. $AKRO #Akero Driven Brands Holdings, Inc. (NASDAQ: DRVN) Class Action Survives Motion to Dismiss: A securities fraud class action complaint against Driven Brands Holdings, Inc. (NASDAQ: DRVN) has survived defendants, attempts to dismiss the complaint. Grabar Law Office is now investigating claims on behalf of long-term Driven Brands shareholders. The investigation concerns whether certain officers of the company have breached their fiduciary duties they owed to the company. If you have held Driven Brands (NASDAQ: DRVN) shares continuously since prior to October 27, 2021, you can seek corporate reforms, the return of funds back to the Company, and a court approved incentive award at no cost you. Visit or contact Joshua H. Grabar at [email protected] or call 267-507-6085 to learn more. WHY: An underlying securities fraud class action complaint alleges that Driven Brands, through certain of its officers and directors, made numerous materially false and misleading statements and omissions pertaining to: (i) Driven Brands' ability to efficiently and effectively integrate a high volume of acquired businesses, including statements related to the status of integrating its U.S. auto glass businesses; and (ii) the performance and competitive position of Driven Brands' car wash business segment. On February 20, 2025, a Federal Court determined that the allegations in the plaintiff's underlying securities fraud class action complaint were adequately pleaded to survive defendants attempts to dismiss the complaint. WHAT TO DO NOW: If you are a current Driven Brands shareholder who has held Driven Brands shares since prior to October 27, 2021, you can seek corporate reforms, the return of funds back to the company, and a court approved incentive award at no cost to you whatsoever. If you would like to learn more about this matter, you are encouraged to visit contact Joshua H. Grabar at [email protected] or call 267-507-6085. $DRVN #DrivenBrands Integra LifeSciences Holdings Corp. (NASDAQ: IART): Grabar Law Office is investigating whether the Board of Directors of Integra LifeSciences Holdings Corp. (NASDAQ: IART) breached their fiduciary duties owed to the Company. Current Integra LifeSciences Holdings Corp. (NASDAQ: IART) shareholders who have held the stock since on or before March 11, 2019, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them. Learn more or join at: Contact Joshua H. Grabar at [email protected], or call 267-507-6085. WHY: An underlying securities fraud class action complaint alleges that Integra, via certain of his officers and directors, repeatedly touted that it was on track to grow SurgiMend's market by obtaining FDA approval for use in post-mastectomy reconstruction, yet on May 23, 2023, the Company was forced to announce a 'recall' of all products manufactured at its Boston Facility between March 1, 2018 and May 22, 2023. Integra LifeSciences explained that it had determined that the Boston Facility deviated from good manufacturing practices in testing for bacterial endotoxin and allowed the release of products with unsafe levels of endotoxins. As a result of the recall and manufacturing shutdown, the Company revised its guidance for the second quarter of 2023, lowering its revenue expectations by and disclosed that it expected to take a $22 million impairment due to the inventory write-off. WHAT TO DO NOW: Current Integra LifeSciences shareholders who have held Integra LifeSciences shares since on or before March 11, 2019, can seek corporate reforms, the return of funds spent defending litigation back to the company, and a court approved incentive award, at no cost to them. If you would like to learn more about this matter, you are encouraged to visit contact Joshua H. Grabar at [email protected], or call us at 267-507-6085. $IART #IntegraLifeSciences Kyverna Therapeutics, Inc. (NASDAQ: KYTX): Grabar Law Office is investigating claims on behalf of Kyverna Therapeutics, Inc. (NASDAQ: KYTX) shareholders. The investigation concerns whether certain officers and directors breached the fiduciary duties they owed to the company. If you are a current Kyverna (NASDAQ: KYTX) shareholder who purchased Kyverna shares on or near its February 8, 2024 IPO and still hold shares today, you may be able to seek corporate reforms, the return of money back to the company, and a court approved incentive award at no cost to you whatsoever. Please visit contact Joshua Grabar at [email protected] or call us at 267-507-6085 Why? On February 8, 2024, Kyverna Therapeutics, Inc. (NASDAQ: KYTX) conducted its IPO, offering 14.5 million shares of its common stock to the public at a price of $22 per share for anticipated proceeds of over $296 million. Kyverna granted the Underwriter Defendants a 30-day option to purchase up to an additional 2.175 million shares of its common stock at the Offering Price, less underwriting discounts and commissions. An underlying securities fraud class action complaint alleges that the registration statement and prospectus issued in connection with the Company's IPO misstated and/or omitted facts concerning the results of the Company's ongoing evaluation of KYV-101 in clinical trials. The Complaint further alleges that unbeknownst to investors, these representations were materially inaccurate, misleading, and/or incomplete because they did not disclose adverse data regarding one of Kyverna's trials, which adverse data was known to the Company at the time of the IPO. What Can You Do Now? If you purchased Kyverna (NASDAQ: KYTX) on or near its February 8, 2024 IPO and still hold shares today, you are encouraged to visit contact Joshua Grabar at [email protected] Contact: Joshua H. Grabar, Esq. Grabar Law Office One Liberty Place 1650 Market Street, Suite 3600 Philadelphia, PA 19103 Tel: 267-507-6085
Yahoo
27-01-2025
- Business
- Yahoo
Akero Therapeutics Shares Surge 106% as Phase 2b Study Shows Significant Cirrhosis Reversal
On Monday, at 10:23 a.m. GMT-5, Akero Therapeutics (AKRO, Financials) saw its stock soar by 106.63%, closing at $54.10, following the release of promising preliminary results from its Phase 2b SYMMETRY study. Warning! GuruFocus has detected 3 Warning Signs with AKRO. The Akero statement underlined how well their medicine efruxifermin treats compensated cirrhosis brought on by metabolic dysfunction-associated steatohepatitis. Akero claims that compared to 15 percent of patients on placebo, 39 percent of patients getting a 50-milligram dosage of EFX showed at least a one-stage improvement in liver fibrosis without worsening MASH, according to the SYMMETRY trial reaching the 96-week milestone. Over the placebo group, this reflects a 24 percent larger impact size. Akero claimed a 17 percent advantage in an intent-to- treat analysis, which accounted for all participants by considering missing biopsies as failures, 29 percent of the EFX group exhibited comparable improvements vs 12 percent in the placebo group. The company's release also highlighted how, in the 50-milligram group, the advantages of EFX more than quadrupled from week 36 to week 96. Furthermore, among patients not on GLP-1 at baseline, 45 percent of those on EFX exhibited cirrhosis reversal compared to 17 percent on placebo, suggesting the benefits were independent of GLP-1 treatment, says Akero. Generally speaking, EFX was tolerated well; there were no treatment group fatalities recorded. Akero said that the most often occurring negative events were mild to severe gastrointestinal problems including nausea and diarrhea. Akero intends to keep assessing the 50-milligram EFX dosage in its current Phase 3 SYNCHRONY Outcomes research, which targets patients with compensated cirrhosis brought on by MASH, the firm said. Akero underlined that these results provide the first published proof of cirrhosis reversal in this patient group. According to Akero, metabolic dysfunction-associated steatohepatitis is a major cause of liver transplants and liver cancer in the United States and Europe as well as expected to impact three million Americans by 2030. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
27-01-2025
- Business
- Yahoo
Akero Therapeutics Shares Surge 106% as Phase 2b Study Shows Significant Cirrhosis Reversal
On Monday, at 10:23 a.m. GMT-5, Akero Therapeutics (AKRO, Financials) saw its stock soar by 106.63%, closing at $54.10, following the release of promising preliminary results from its Phase 2b SYMMETRY study. Warning! GuruFocus has detected 3 Warning Signs with AKRO. The Akero statement underlined how well their medicine efruxifermin treats compensated cirrhosis brought on by metabolic dysfunction-associated steatohepatitis. Akero claims that compared to 15 percent of patients on placebo, 39 percent of patients getting a 50-milligram dosage of EFX showed at least a one-stage improvement in liver fibrosis without worsening MASH, according to the SYMMETRY trial reaching the 96-week milestone. Over the placebo group, this reflects a 24 percent larger impact size. Akero claimed a 17 percent advantage in an intent-to- treat analysis, which accounted for all participants by considering missing biopsies as failures, 29 percent of the EFX group exhibited comparable improvements vs 12 percent in the placebo group. The company's release also highlighted how, in the 50-milligram group, the advantages of EFX more than quadrupled from week 36 to week 96. Furthermore, among patients not on GLP-1 at baseline, 45 percent of those on EFX exhibited cirrhosis reversal compared to 17 percent on placebo, suggesting the benefits were independent of GLP-1 treatment, says Akero. Generally speaking, EFX was tolerated well; there were no treatment group fatalities recorded. Akero said that the most often occurring negative events were mild to severe gastrointestinal problems including nausea and diarrhea. Akero intends to keep assessing the 50-milligram EFX dosage in its current Phase 3 SYNCHRONY Outcomes research, which targets patients with compensated cirrhosis brought on by MASH, the firm said. Akero underlined that these results provide the first published proof of cirrhosis reversal in this patient group. According to Akero, metabolic dysfunction-associated steatohepatitis is a major cause of liver transplants and liver cancer in the United States and Europe as well as expected to impact three million Americans by 2030. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
27-01-2025
- Business
- Yahoo
Akero Therapeutics Reports Preliminary Topline Results Showing Statistically Significant Reversal of Compensated Cirrhosis (F4) Due to MASH—by Both Completer and ITT Analyses—at Week 96 in Phase 2b SYMMETRY Study
Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group (p=0.009) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 24% effect size over placebo at 15% By ITT analysis, with all missing week 96 biopsies treated as failures, 29% of the 50mg EFX group (p=0.031) demonstrated ≥1 stage improvement in fibrosis with no worsening of MASH, representing a 17% effect size over placebo at 12% Investor webcast at 8:00 am ET Monday, January 27, 2025 SOUTH SAN FRANCISCO, Calif., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Among patients with baseline and week 96 biopsies (n=134), 39% of patients treated with 50mg EFX (n=46) (p=0.009) experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo (n=47). In the Intent to Treat (ITT) population (n=181), with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group (n=63) (p=0.031) experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group (n=61). With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4). In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline (n=97), 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH (n=29) (p=0.009) compared to 17% for placebo (n=36), suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy. 'Until today, we've not had the prospect of an effective treatment for compensated cirrhosis due to MASH, which is associated with high rates of short-term morbidity and mortality,' said Mazen Nourredin, M.D., Professor of Medicine and Transplant Hepatologist at Houston Methodist Hospital, and principal investigator for the SYMMETRY study. 'Now we have reason to be optimistic about the future potential of EFX as a much-needed treatment for cirrhosis, if approved. I'm so happy for my patients and patients all around the world.' Summary of Week 96 Reversal of Cirrhosis Endpoint Primary Analysis (N=134)1 ITT Analysis (N=181)2 Histology Endpoint3 (Proportion of Patients) Placebo(N=47) 28mg(N=41) 50mg(N=46) Placebo(N=61) 28mg(N=57) 50mg(N=63) ≥1 stage fibrosis improvement without worsening MASH (%) 15 29 39 ** 12 21 29 * 1 All patients with baseline and week 96 biopsies2 The 47 randomized and dosed patients who had missing biopsies at week 96 are treated as failures in the ITT analysis (without imputation)3 Biopsies scored independently by two pathologists; third available to adjudicate (which was not required)* p<0.05, ** p<0.01, versus placebo (Cochran-Mantel-Haenszel test (CMH)) 'We believe today's first-ever public report of reversal of cirrhosis due to MASH, whether by completer or ITT analysis, sets EFX apart from other approved or investigational treatments in the MASH landscape as a compound with transformational potential,' said Andrew Cheng, M.D., Ph.D., president and chief executive officer of Akero. 'We look forward to continuing evaluation of 50mg EFX in our ongoing Phase 3 SYNCHRONY Outcomes study in patients with compensated cirrhosis due to MASH.' The reversal of cirrhosis, as quantified by a consensus of two histopathologists, is supported by improvements in noninvasive measures of liver fibrosis and injury. Summary of Week 96 Changes in Key Noninvasive Measures of Liver Fibrosis and Injury Measure (LS Mean Change From Baseline to Week 96) Placebo(n=49) 28mg(n=40-41) 50mg (n=47) ELF Score +0.22 -0.34 *** -0.53 *** Liver Stiffness (%) (FibroScan) -8 -18 -24 * ALT (U/L) -6.8 -10.5 -11.1 AST (U/L) -1.6 -8.1 -11.2 ** * p<0.05, *** p<0.001, versus placebo (MMRM) EFX was reported to be generally well-tolerated. There were no deaths on EFX, but one death in the placebo arm due to pneumonia. None of the Serious Adverse Events were determined to be related to study drug. Across both EFX groups, the most frequent adverse events (AEs) were grade 1 or 2, gastrointestinal in origin (diarrhea, nausea, and increased appetite) and transient in nature. Conference Call / Webcast DetailsAkero will host a conference call and webcast with slide presentation at 8:00 a.m. ET today. The live webcast will be available on the Events & Presentations page of Akero's website, with the recording and presentation available immediately following the event. About Cirrhosis Due to MASH Cirrhosis due to MASH (metabolic dysfunction-associated steatohepatitis) is a life-threatening disease with high risk of liver failure, cancer and eventually death. By 2030, an estimated 3 million Americans are projected to have MASH cirrhosis, which is the fastest growing cause of liver transplants and liver cancer in the United States and Europe. About the SYMMETRY Study The Phase 2b SYMMETRY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in adult patients with biopsy-confirmed compensated cirrhosis (F4, Child-Pugh A) due to MASH. The study enrolled a total of 182 patients, randomized to receive once-weekly subcutaneous dosing of 28mg or 50mg EFX, or placebo for 36 weeks, 181 of whom received at least one study dose. The primary efficacy endpoint for the study was the proportion of patients who achieve at least one-stage fibrosis improvement without worsening of MASH at week 36. Week 96 secondary measures included ≥1 stage fibrosis improvement and no worsening of MASH, MASH resolution, change from baseline in liver enzymes, noninvasive markers of liver fibrosis, glycemic control, and lipoproteins, as well as safety and tolerability measures. About EFXEfruxifermin (EFX), Akero's lead product candidate for MASH, is currently being evaluated in three ongoing Phase 3 studies. In multiple Phase 2 studies, EFX has been observed to reverse fibrosis (including compensated cirrhosis), resolve MASH, reduce non-invasive markers of fibrosis and liver injury, and improve insulin sensitivity and lipoprotein profile. This holistic profile offers the potential to address the complex, multi-system disease state of all stages of MASH, including improvements in lipoprotein risk factors linked to cardiovascular disease – the leading cause of death among MASH patients. Engineered to mimic the biological activity profile of native FGF21, EFX is designed to offer convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date. About Akero TherapeuticsAkero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including metabolic dysfunction-associated steatohepatitis (MASH). Akero's lead product candidate, EFX, is currently being evaluated in three ongoing Phase 3 clinical studies: SYNCHRONY Histology in patients with pre-cirrhotic MASH (F2-F3 fibrosis), SYNCHRONY Outcomes in patients with compensated cirrhosis due to MASH, and SYNCHRONY Real-World in patients with MASH or MASLD (Metabolic Dysfunction Associated Steatotic Liver Disease). The Phase 3 SYNCHRONY program builds on the results of two Phase 2b clinical trials, the HARMONY study in patients with pre-cirrhotic MASH and the SYMMETRY study in patients with compensated cirrhosis due to MASH. Akero is headquartered in South San Francisco. Visit us at and follow us on LinkedIn and X for more information. Forward Looking StatementsStatements 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 and ongoing clinical studies, the therapeutic effects of EFX, as well as the dosing, safety and tolerability of EFX; and the future potential of EFX following the preliminary topline week 96 results of Akero's Phase 2b SYMMETRY study, which are subject to audit and verification procedures and additional data that could result in material changes in the final data. 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. Investor Contact:Christina TartagliaPrecision Media Contact:Peg Rusconi Deerfield in to access your portfolio
