The responders achieved NASH resolution with no worsening of fibrosis. Improvements in glycemic control and dyslipidemia, as well as weight loss were also observed across all dose groups.

Stephen Harrison, M.D., medical director of Pinnacle Clinical Research said,  “These substantial improvements observed in multiple measures of liver health, particularly the one- and two-stage improvements in fibrosis, are extremely encouraging and among the strongest biopsy results reported in NASH to date. I believe Efruxifermin continues to set itself apart as one of the most promising drug candidates in NASH, with impressive histology results after just 16 weeks of treatment.”

The Drug, Efruxifermin (EFX)

Efruxifermin (EFX), formerly known is Akero’s lead product candidate for NASH, currently being evaluated in the ongoing Phase 2a BALANCED study. The drug is designed to reduce liver fat and inflammation, reverse fibrosis, increase insulin sensitivity and improve lipoproteins. The product improved lipoprotein the risk factors linked to cardiovascular disease – the leading cause of death in NASH patients. Important also is that the drug is offering convenient once-weekly dosing and has been generally well-tolerated in clinical trials to date.

EFX Safety

There were no deaths in the study.  There were two serious adverse events: one of which occurred prior to dosing. The most frequent adverse effects were grade 1 or 2 gastrointestinal events, which were transient in nature. There were no discontinuations due to treatment-emergent adverse events in the 50 mg dose group and no discontinuations due to the most common adverse event, diarrhea. There were no treatment effects on blood pressure, heart rate or bone mineral density.

EFX was generally reported to be well tolerated.

From the President and CEO of Akero Therapeutics

Cheng, M.D., Ph.D., president and CEO of Akero stated, “We believe the BALANCED study data, which exceeded our expectations, demonstrate the strong potential of efruxifermin to be a foundational monotherapy for the treatment of NASH. We look forward to the continued development of efruxifermin and are working diligently to deliver this potentially leading treatment to patients. We are extremely grateful to all of our investigators and study patients, particularly given that this study cohort was completed amidst the COVID-19 pandemic.”

EFX BALANCED Study

The BALANCED study is an ongoing randomized, double-blind, placebo-controlled study in NASH patients. The company has previously reported that each of the 28, 50 and 70 mg EFX dose groups met the primary endpoint compared to placebo, with absolute reductions of 12, 13 and 14 percent of liver fat, respectively, compared with 0.3 percent for placebo, and relative reductions of 63, 71 and 72 percent compared to 0 percent for placebo.

All of these results were highly statistically significant.

On June 30, 2020 the firm hosted a conference call and webcast with slide presentation. A replay is available on the company’s website for 90 days.

Why Are There Huge Efforts Spent on Treating NASH?

NASH (non-alcoholic steatohepatitis) is a serious form of NAFLD (non-alcoholic fatty liver disease). NASH is linked to the endemic of obesity and diabetes witnessed around the world. The excessive accumulation of fat in the liver causes stress and injury to liver cells, leading to inflammation and fibrosis, which can progress to cirrhosis, liver failure, cancer, and eventually death. NASH is a leading cause of liver transplants in the US and Europe. 

About Akero Therapeutics

Akero is a cardio-metabolic NASH company with a goal to reverse the escalating NASH epidemic with products designed to restore metabolic balance to improve overall health.  Akero is headquartered in South San Francisco, CA. 

For more information, please visit www.akerotx.com/.  

Prohost Observations

The results above are indeed promising; they demonstrate safety, efficacy and tolerability with statistically significant results.  These results are extremely important as NASH is a complex disease bringing with it grave health conditions including: type 2 diabetes, high cholesterol, obesity and cardiovascular disease. The disease is known to be the leading cause of liver transplantation worldwide.

Currently no medications are approved for NASH. Many companies are now working fervently to improve detection and to develop effective treatments.

Investigational NASH therapies are classified as either metabolic or anti-inflammatory/fibrotic; EFX has been demonstrating both actions. It redirects calories away from the liver, restores lipid metabolism in the liver to a healthy state, and protects against hepatocyte stress and death. It also directly suppresses downstream inflammation and fibrosis.

This is exciting news, especially since it’s coming from a development-stage firm.

To read Prohost Biotech’s decision about Akero Therapeutics click here.