Post hoc analysis shows potential for EFX to treat patients at highest genetic risk for progressive and advanced NASH
SOUTH SAN FRANCISCO, Calif., June 27, 2022 (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 the presentation of an analysis from its Phase 2a BALANCED study of efruxifermin (EFX) in patients with biopsy-confirmed F1-F3 fibrosis associated with non-alcoholic steatohepatitis (NASH). The data was presented at the 2022 International Liver Congress in a poster titled “Efruxifermin treatment improved histopathology and non-invasive markers of liver injury and fibrogenesis in NASH patients across PNPLA3 genotypes: a post hoc analysis of the Ph2a BALANCED study” (Poster SAT-114). The poster is available on Akero’s website.
Genetic variants in the PNPLA3 gene have been shown to significantly increase risk of NASH-related disease progression and fibrosis severity. Carriers of the I148M variant, which is prevalent among NASH patients, have a greater-than-threefold increased risk of NASH fibrosis and are at increased risk for progressing to end-stage liver disease, including hepatocellular carcinoma. A therapeutic that is proven to be effective in treating patients who carry the I148M variant could therefore help address an important unmedical need. The data presented at the 2022 International Liver Congress show that EFX treatment improved histopathology and noninvasive markers of liver injury across PNPLA3 genotypes, including in patients carrying the I148M variant. The data presented are based on 58 of the 80 study patients with biopsy-confirmed F1-F3 fibrosis in the BALANCED main study who consented to undergo genetic analyses. In addition to NASH histology across PNPLA3 I148M genotypes, the data also included analyses of EFX effects on liver fat content, serum triglycerides, and markers such as ALT, AST, GGT, Pro-C3, HbA1C, C-peptide, adiponectin, and HOMA-IR, across PNPLA3 I148M genotypes.
“We believe that EFX has the potential to treat patients with NASH who are at highest risk of disease progression, including patients who carry certain genetic variants in the PNPLA3 gene,” said Tim Rolph, chief scientific officer of Akero. “This new analysis of the Phase 2a BALANCED data, showing that response rates among patients who carry the PNPLA3 I148M variant were generally comparable to the response rates of those without it, provide further evidence of EFX’s potential to meet an important unmet medical need in NASH.”
EFX is currently being evaluated in two, parallel Phase 2b clinical trials, HARMONY and SYMMETRY, with results from the HARMONY study of patients with F2-F3 fibrosis expected in the third quarter of this year.
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by high unmet medical need, including 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 two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with cirrhotic NASH (F4 fibrosis, compensated). Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.
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