SOUTH SAN FRANCISCO - Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company, announced significant clinical outcomes from its Phase 2b HARMONY study, evaluating the efficacy of efruxifermin (EFX) in treating metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease. The findings were presented at the 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, held on November 15-19, 2024.
The study revealed that after 96 weeks of EFX treatment, over 40% of participants exhibited regression of liver fibrosis, a key indicator of MASH progression. This includes improvements in liver histopathology, a reduction in liver stiffness as measured by FibroScan®, and decreased serum fibrosis markers. In comparison, none of the placebo group showed similar improvements.
Furthermore, 30% of those treated with EFX 50mg achieved near-complete reversal of MASH-related disease, including fibrosis regression to minimal levels, resolution of steatohepatitis, and normalization of liver fat content. In contrast, all placebo participants continued to present a high or indeterminate risk of progressive MASH.
The data also highlighted that EFX treatment led to statistically significant reductions in fibrosis within the perisinusoidal and periportal zones of the liver, as confirmed by AI-based digital pathology.
Akero's chief development officer, Kitty Yale, expressed optimism about the potential of EFX as a differentiated therapy for MASH, citing consistent improvements across various liver health markers and the corroboration of histopathology assessments with AI-based digital pathology.
The HARMONY study's results set the stage for the ongoing Phase 3 SYNCHRONY program, which aims to confirm EFX's favorable benefit-risk profile and support marketing applications for MASH treatment.
The press release statement from Akero Therapeutics, which provided the source of information, emphasized the clinical activity and safety of EFX in patients with pre-cirrhotic MASH. However, it should be noted that positive results from clinical studies may not necessarily predict future or ongoing study outcomes.
In other recent news, Akero Therapeutics has made notable progress with its Phase 3 trial for a treatment aimed at MASH patients with compensated cirrhosis, named SYNCHRONY Outcomes. This development has led H.C. Wainwright to maintain a Buy rating for the company. The trial is evaluating the efficacy of efruxifermin (EFX) in patients with fibrosis stage 4 (F4) and plans to enroll approximately 1,150 patients.
The first patient has been dosed, marking a significant step for Akero as it now has all three Phase 3 trials of EFX underway. The trial's first cohort will assess fibrosis regression without worsening of MASH after a 96-week treatment period. Following this phase, the trial will continue to monitor patients to evaluate primary outcomes related to mortality and liver-related clinical events.
In addition to these developments, investors are eagerly awaiting the Week 96 data release from the ongoing Phase 2b SYMMETRY study, expected in the first quarter of 2025. This data will provide insights into the long-term effects of EFX on F4 MASH patients and is considered a crucial near-term milestone for Akero and its EFX treatment.
InvestingPro Insights
Akero Therapeutics' promising clinical results for efruxifermin (EFX) in treating MASH are reflected in the company's recent financial performance. According to InvestingPro data, Akero has seen a remarkable 103.14% price total return over the past year, indicating strong investor confidence in the company's potential.
Despite the positive clinical outcomes, it's important to note that Akero is still in the development stage and not yet profitable. An InvestingPro Tip reveals that analysts do not anticipate the company will be profitable this year. This is consistent with the nature of clinical-stage biotechnology companies, which often require substantial investment in research and development before generating revenue.
However, Akero's financial position appears stable. Another InvestingPro Tip highlights that the company holds more cash than debt on its balance sheet, which is crucial for funding ongoing clinical trials and potential commercialization efforts. Additionally, Akero's liquid assets exceed short-term obligations, providing financial flexibility as it progresses through its clinical pipeline.
The market seems to be pricing in future potential, with Akero's market capitalization standing at $1.93 billion. This valuation reflects investor optimism about EFX's prospects in the MASH treatment market.
For investors seeking a more comprehensive analysis, InvestingPro offers 12 additional tips for Akero Therapeutics, providing deeper insights into the company's financial health and market position.
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