Core Insights - Akero Therapeutics reported significant advancements in its clinical programs for Efruxifermin (EFX), particularly in the treatment of metabolic dysfunction-associated steatohepatitis (MASH) and compensated cirrhosis [2][5][13] Clinical Development - The Phase 2b SYMMETRY study demonstrated a statistically significant reversal of compensated cirrhosis (F4) in patients treated with 50mg EFX for 96 weeks, with 39% of patients showing ≥1 stage improvement in fibrosis [6][11] - The Phase 3 SYNCHRONY program is ongoing, consisting of three randomized, placebo-controlled trials aimed at evaluating the safety and efficacy of EFX in patients with MASH and compensated cirrhosis [10][13] - Preliminary results from the SYNCHRONY Real-World study, which enrolled 601 patients, are expected in the first half of 2026 [10] Financial Performance - For the year ended December 31, 2024, Akero reported cash, cash equivalents, and short- and long-term marketable securities totaling 402.5 million in January 2025 [9][10] - Research and development expenses increased to 141.8 million in 2023, primarily due to costs associated with clinical trials [9][17] - The net loss for the year was 151.8 million in 2023, reflecting increased operational expenses [17] Market Context - MASH is a serious condition affecting approximately 17 million Americans, with no approved treatments currently available, highlighting a significant unmet medical need [12][13] - The condition is the fastest-growing cause of liver transplants and liver cancer in the US and Europe, emphasizing the urgency for effective therapeutic options [12]
Akero Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update