AKRO - Akero Therapeutics to Present Late-Breaking Oral and Poster Presentations on EFX at AASLD's The Liver Meeting® 2023 | Benzinga
Phase 2b SYMMETRY 36-week data, including new subgroup analysis, showed that EFX is active in patients with advanced cirrhosis and support continued development of EFX for treatment of cirrhosis due to NASH/MASH
22% and 10% of patients with more advanced cirrhosis in the 50mg and 28mg dose groups, respectively, had at least a one-stage improvement in fibrosis without worsening of NASH, over 7 and 3 times, respectively, the placebo rate of 3%
Additional analyses from the HARMONY and SYMMETRY studies indicate that histological improvements associated with EFX do not appear to be attributable to concomitant use of GLP-1
SOUTH SAN FRANCISCO, Calif., Nov. 10, 2023 (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 announced it will present a late-breaking oral presentation and a poster featuring its lead product candidate efruxifermin (EFX) at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting® 2023 being held November 10-14 in Boston, MA.
The oral presentation will detail a recently announced 36-week analysis of SYMMETRY, a 96-week Phase 2b study evaluating the efficacy and safety of EFX in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis (NASH/MASH). A new analysis of a subgroup comprised of 84 patients diagnosed with cirrhosis due to NASH/MASH at least 6 months before treatment with EFX or those with cryptogenic cirrhosis at baseline provides further evidence of EFX's activity in this advanced cirrhotic population, with a trend to higher rates of fibrosis improvement without NASH/MASH worsening in 10% and 22% of those treated with 28mg and 50mg EFX, respectively, compared to 3% for placebo. Another analysis of the 36-week SYMMETRY study data showed that the trend for EFX to reverse cirrhosis did not appear to be attributable to concomitant use of GLP-1.
The poster describes data from SYMMETRY Cohort D, which evaluated treatment of EFX in combination with a GLP-1 receptor agonist in patients with F1-F3 NASH/MASH and Type 2 diabetes. The poster also includes subgroup analyses from HARMONY showing that improvements in liver histology among F2-F3 NASH/MASH patients associated with EFX treatment with EFX, do not appear to be attributable to concomitant use of GLP-1.
EFX was reported to be generally well-tolerated in the SYMMETRY main study and Cohort D. Overall, the most frequent adverse events were transient, mild-to-moderate gastro-intestinal grade 1 or 2 events.
"Analyses of data from the SYMMETRY and HARMONY Phase 2b studies, which will be presented at The Liver Meeting®, underscore EFX's promising activity profile and support continued development in both the pre-cirrhotic and cirrhotic NASH/MASH patient populations," said Kitty Yale, chief development officer ...