On June 2, Boehringer Ingelheim and Zealand Pharma jointly announced that the FDA has granted GLP-1/glucagon receptor (GCCR) dual agonist BI 456906 fast track designation for adult non-alcoholic steatohepatitis ( NASH).
BI 456906 is derived from the natural intestinal hormone oxyntomodulin, which can activate GLP-1 and glucagon receptors that are essential for controlling metabolic functions.
It is expected to become a new once-a-week dosing that is superior to existing therapies.
The drug is part of Boehringer Ingelheim's research and development product portfolio in the field of cardiometabolic diseases, and its research indications also include diabetes and obesity.
Currently, BI 456906 is conducting a randomized, double-blind, placebo-controlled Phase II clinical study (NCT04771273) to evaluate the efficacy of the drug in adult patients with NASH and liver fibrosis (F2/F3).
In the trial, patients received subcutaneous injections of BI 456906 or placebo at different doses once a week.
The primary endpoint was histological improvement of steatohepatitis without deterioration of fibrosis after 48 weeks of treatment.
In China, Boehringer Ingelheim submitted a clinical application as early as December 22, 2020, and has launched an international multi-center phase 2 clinical trial for obese patients.
Domestic progress of BI 456906 project
From the Insight database (http://db.
Non-alcoholic steatohepatitis (NASH) is one of the main causes of liver fibrosis and cirrhosis.
Its symptoms are usually asymptomatic or non-NASH-specific, making it difficult to diagnose.
This is an area with unmet medical needs, and there are currently no approved treatments.
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