Expert Interview
Examining the Phase 2b SYMMETRY Study Results for Efruxifermin (EFX) in MASH-Related Compensated Cirrhosis from Akero Therapeutics
Ticker(s): AKROA hepatologist or gastroenterologist with expertise in MASH-related liver disease, clinical trial experience, and an understanding of fibrosis progression and reversal. The expert should also be familiar with non-invasive assessment methods for liver disease and evolving therapeutic strategies for cirrhosis management.
The SYMMETRY study demonstrated a 39% response rate in fibrosis improvement without worsening MASH at Week 96 for the 50mg EFX group, significantly outperforming placebo. Given that there are no approved treatments for MASH-related cirrhosis, how do you interpret these results in the context of current clinical practice?
Added By: slingshot_insightsThe study highlights that the effect size more than doubled between Weeks 36 and 96 in the 50mg EFX group (from 10% to 24%). What does this suggest about the long-term therapeutic potential of EFX, and could we expect even greater benefits with continued treatment?
Added By: slingshot_insightsAlongside biopsy-confirmed improvement, significant reductions were observed in ELF score (-0.53), liver stiffness (-24%), and AST levels (-11.2). How reliable are these non-invasive markers in tracking fibrosis regression, and do they provide additional confidence in EFX’s efficacy?
Added By: slingshot_insightsIn patients who were not on baseline GLP-1 therapy, the fibrosis reversal rate in the 50mg EFX group increased to 45%. What do these findings imply about EFX’s independent mechanism of action, and could it be a preferred option for patients not receiving GLP-1-based therapies?
Added By: slingshot_insightsDespite the severity of disease in this study population, EFX was well-tolerated, with no treatment-related deaths and mostly mild, transient gastrointestinal adverse events. How does this safety profile compare to existing cirrhosis management strategies, and could it facilitate broad clinical adoption?
Added By: slingshot_insightsMASH is the fastest-growing cause of liver transplantation in the U.S. and Europe. If EFX continues to show durable reversal of cirrhosis in Phase 3, could this treatment help delay or reduce the need for liver transplants in this patient population?
Added By: slingshot_insightsGiven that the SYNCHRONY Phase 3 program is already underway, what are the key regulatory considerations for EFX approval? Could the strength of the fibrosis improvement data at Week 96 influence the FDA’s and EMA’s assessment of an accelerated pathway?
Added By: slingshot_insightsIf approved, EFX would represent a breakthrough in treating MASH-related cirrhosis. How do you see it fitting into the broader treatment paradigm alongside metabolic interventions, lifestyle modifications, and other emerging pharmacotherapies?
Added By: slingshot_insightsAre You Interested In These Questions?
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