NASH new drug arrived at approved standards, key trials are about to begin

NASH new drug arrived at approved standards, key trials are about to begin

June 13, 2018 Source: WuXi PharmaTech

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Today is the first International Non-Alcoholic Fatty Hepatitis Day (First International NASH Day). In the pharmaceutical industry, a clinical trial news about NASH has also attracted a lot of attention: Galmed Pharmaceuticals announced that its oral NASH therapy Aramchol has obtained positive Phase 2b clinical data that meets the FDA's regulatory approval endpoint.

NASH is a new type of global health crisis that affects approximately 2% to 4% of the total population. This is a progressive liver disease that can lead to serious consequences such as cirrhosis and liver cancer. It is also one of the leading causes of liver cancer or liver transplantation in the United States. Although it poses a crisis for global health, we still lack the means to effectively treat the disease.

Aramchol, brought by Galmed, is an innovative fatty acid and bile acid conjugate that acts as a beneficial regulator of intrahepatic lipid metabolism. In animal experiments, it can effectively reduce the pathological features of the three major NASHs of steatosis, inflammation, and fibrosis.

In a phase 2b clinical trial called ARREST, the researchers recruited 247 patients who were confirmed to have NASH by biopsy and divided them into three groups at a ratio of 2:2:1, receiving 600 mg of Aramchol, respectively. Treatment with 400 mg Aramchol, as well as placebo. The primary clinical endpoint of the study was a change in the proportion of hepatic triglycerides, and the secondary endpoint included an improvement in the degree of fibrosis in the absence of deterioration of NASH symptoms (inflammation and/or hepatocyte ballooning). In addition, the degree of relief of NASH disease is also one of the secondary endpoints in the absence of deterioration in the degree of fibrosis.

â–² test results of the study (Source: Galmed Pharmaceuticals official website)

The study obtained complex experimental data. At the primary clinical endpoint, the 400 mg group significantly reduced liver fat (p = 0.0450), whereas the 600 mg group failed to achieve this goal. However, the proportion of patients who achieved a 5% absolute improvement in the 600 mg group was significantly higher than the placebo group, reaching 47.0% (control group 24.4%, p = 0.0279).

Many analysts point out that one of the highlights of this trial is the positive data obtained at its secondary clinical endpoint. Studies have shown that in patients with the 600 mg group, more patients have a remission of NASH in the absence of worsening fibrosis (16.7% vs. 5.0%, p = 0.0514); similarly, in the absence of NASH disease, there are The degree of fibrosis was improved in more patients (29.5% versus 17.5%, p = 0.2110). It is worth mentioning that this is the end of the phase III clinical trial recommended by the US FDA. This also allows us to see the hope of Aramchol's approval.

â–²The study met the FDA recommended endpoint requirements (Source: FDA)

"These exciting results indicate that 600 mg of Aramchol can improve the degree of fibrosis and progression of cirrhosis. In the long run, this may lead to meaningful clinical improvement," said Professor Arun Sanyal of the University of California, Berkeley School of Public Health. "More importantly, these effects are dose dependent, and this clinical trial is a global study. This suggests that the results of this trial are likely to be replicated in Phase 3 clinical trials."

“We are very pleased to see the results of the ARREST trial. It allows us to discuss the design of key trials with regulators as soon as possible,” said Allem Baharaff, President and CEO of Galmed. “Aramchol's scientifically improved NASH can be transformed. This is a very welcome thing for clinical results."

We hope that the follow-up study of this new drug will go smoothly, bring new drugs to patients at an early date, and solve the growing health crisis of NASH.

Reference materials:

[1] Galmed's 600 mg AramcholTM Achieved a Regulatory Approvable Endpoint Showing NASH Resolution Without Worsening of Fibrosis, in NASH Patients, in the Global Phase 2b ARREST 52-Week Study

[2] Galmed's stock rockets up as execs tout a mixed set of NASH data

[3] Galmed Pharmaceuticals Official Website

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