▎ WuXi AppTec content team editor

"We believe the results of today's HARMONY trial are an important milestone for Akerero and the entire population of non-alcoholic steatohepatitis (NASH) patients!"

—Dr.

Today, there is a big news

NASH is a widely affected disease, patients due to excessive accumulation of liver fat, chronic inflammation, which in turn causes the destruction of liver cells and liver fibrosis, which in severe cases can lead to cirrhosis, liver failure, liver cancer and death

The innovative therapy brought by Akero is called efruxifermin (formerly known as AKR-001), which is a similar to

▲Efruxifermin profile (Image source: Akero official website)

The drug's potential was validated in a clinical 2b trial called HARMONY

▲Both doses of efruxifermin reached the main endpoint of the trial (Source: Akero official website)

In addition, NASH symptoms were relieved in up to 76% (p<0.

It is worth mentioning that the draft guidelines for the registration of clinical phase 3 trials of NASH drugs previously published by the US FDA indicate that these two liver histological evaluations can be used as clinical endpoints

After the results of Akero's trial were announced, there were many media reports and discussions, and most of them expressed optimism about the data, such as industry media Fiere Biotech and STAT, which believe that efruxifermin has the potential
to treat liver fibrosis and eventually become a new drug for NASH.

And industry media BioSpace even called efruxifermin "a foundational drug full of potential!" Michael Yee, Managing Director of Jefferies Investments, agrees that the published data is sufficient to support the drug's progress towards
a larger Phase 3 trial.

In addition to optimism, industry media Endpoints News reminded the industry to pay attention to the safety of drugs - although a total of 128 patients were enrolled, they finally completed two liver biopsies, and only 113 patients underwent efficacy analysis
.

Treatment was discontinued in 5 patients due to adverse reactions and 4 patients had serious adverse reactions
.

Although only 1 in patients with serious adverse reactions is considered to be related to drug treatment, long-term safety data for the drug will undoubtedly be one
of the keys to the approval of this new drug.

Image credit: 123RF

Akero also has a phase 2b clinical trial of efruxifermin underway
.

The trial, known as SYMMETRY, enrolls NASH patients with cirrhosis (advanced liver fibrosis), and the results are expected to be published
in the second half of 2023.

Akero intends to conduct further discussions
with the regulators after completing this trial.

However, since the drug has been qualified as a Priority Medicines (PRIME) by the European Medicines Agency (EMA), Akero can immediately discuss
with the EMA based on the trial data published today.

On the other hand, Dr.
Tim Rolph, co-founder and chief scientific officer of the company, also said that he would apply to the US FDA for the identification
of a breakthrough therapy for the treatment of NASH with this drug.

With the increase in the world's obese population, the rate of NASH patients has gradually increased, but this potentially fatal serious disease is still incurable, and it is hoped that with the results of this clinical trial as an opportunity, we can witness the first breakthrough NASH treatment drug as soon as possible in the future, benefiting more patients
around the world.

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