Akero Therapeutics Highlights Positive EFX Results at AASLD 2024

Akero Therapeutics Showcases New Findings on EFX

At the prestigious 75th Annual American Association for the Study of Liver Diseases (AASLD) The Liver Meeting, Akero Therapeutics, Inc. (Nasdaq: AKRO) presented compelling analyses from their Phase 2b HARMONY study. The conference, held in San Diego, gathered numerous medical experts, offering an excellent venue for displaying groundbreaking research in liver health.

The results shared at the meeting demonstrated significant improvements in patients treated with efruxifermin (EFX), specifically those diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). An astonishing 40% of participants who received EFX at a 50mg dosage for 96 weeks showed regression of liver fibrosis, a stark contrast to the 0% outcome seen in the placebo group.

Understanding the Positive Outcomes

The EFX treatment outcomes were assessed through multiple sophisticated methods. These included traditional histopathology evaluations and innovative Artificial Intelligence-based digital pathology techniques. The analysis revealed a substantial reduction in fibrosis among EFX-treated patients, confirming what was previously noted through conventional assessments.

Kitty Yale, Akero's chief development officer, expressed optimism regarding the findings. She noted, "The data showcased at The Liver Meeting indicate that a 96-week treatment with EFX shows vast potential to reverse disease in patients affected by pre-cirrhotic MASH," adding that the combination of established clinical markers and AI analysis reinforces the promising potential of EFX treatments.

Diving into the Results

Regarding the study specifics, an oral presentation highlighted the results from 96 weeks of treatment within the HARMONY study. These results not only encompassed traditional histopathology evaluations but also detailed the participants' responses measured by standard clinical metrics of liver fibrosis. The use of AI-based digital pathology proved to further substantiate the significant improvements noted in fibrosis reduction, further lending credibility to the efficacy of the EFX treatment.

Among key findings, over 30% of participants receiving EFX exhibited nearly complete resolution of MASH-related disease. This outcome included a startling reversion of fibrosis to scores of F?1, resolution of steatohepatitis, and a normalization of liver fat to ?5%. Such results bolster the evidence that EFX is not merely an adjunctive treatment but a pivotal therapeutic approach for those struggling with liver diseases caused by metabolic dysfunctions.

Broader Implications for Liver Health

The implications of these findings extend beyond individual patient improvement. The ongoing Phase 3 SYNCHRONY program, which is crucial for reaffirming the benefits of EFX therapy, aims to establish its impact on the broader landscape of metabolic disease treatment. With three clinical trials currently underway, Akero hopes to gather even more comprehensive data that will support future marketing applications for EFX.

Presentation Highlights at AASLD

Several presentations during the meeting stood out, one being titled "Efruxifermin Significantly Improved Liver Fibrosis at Week 96 in the HARMONY Study Across Subgroups and Improvements Were Associated With Changes in Biomarkers." This particular session, delivered by Dr. Mazen Noureddin, included an extensive analysis of liver biopsies, demonstrating significant changes due to EFX treatment. Another poster presentation corroborated these results by detailing how AI could assist in accurately identifying these therapeutic changes.

About Akero Therapeutics

Akero Therapeutics is dedicated to innovating treatments for patients facing challenging metabolic diseases. With a leading product candidate, EFX, currently reflecting promising outcomes from clinical trials, AKRO stands at the forefront of development aimed at addressing the high unmet needs within liver disease populations. The company continues to push forward, emphasizing the importance of transforming learning from clinical studies into impactful therapeutic interventions.

Frequently Asked Questions

What is the Phase 2b HARMONY study?

The Phase 2b HARMONY study evaluates the efficacy of efruxifermin (EFX) in treating metabolic dysfunction-associated steatohepatitis (MASH).

What were the results presented at AASLD 2024?

Results showcased significant liver fibrosis regression in over 40% of EFX-treated participants, contrasted with no improvement in the placebo group.

Who is the chief development officer of Akero Therapeutics?

Kitty Yale is the chief development officer and expressed strong optimism about EFX's potential based on study results.

What future studies are planned for EFX?

Akero is conducting the Phase 3 SYNCHRONY program, which aims to confirm EFX's therapeutic benefits and support potential marketing applications.

How can patients learn more about Akero Therapeutics?

Patients can visit Akero's official website or follow the company on social media platforms to stay updated on the latest news and research outputs.

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