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April 14, 2021 // - Boehringer Ingelheim and Zealand Pharmaceuticals recently announced the launch of two phase 2 clinical trials to evaluate GLP-1/glucagon (GCG) dual The agonist BI456906 is used to treat overweight or obese adults and to treat non-alcoholic steatohepatitis (NASH) adults.
Obesity and NASH are areas with significant unmet medical needs, and currently approved treatments are limited.
These diseases are associated with lower quality of life and higher mortality.
By combining GLP-1 and GCG activation mechanisms, BI456906, as a dual agonist, has the potential to achieve greater weight loss by improving the patient's metabolism, and also has the potential to reduce NASH by reducing upstream steatosis.
These diseases are associated with lower quality of life and higher mortality.
By combining GLP-1 and GCG activation mechanisms, BI456906, as a dual agonist, has the potential to achieve greater weight loss by improving the patient's metabolism, and also has the potential to reduce NASH by reducing upstream steatosis.
Compared with currently available single GLP-1 agonist compound treatments, weekly BI456906 treatment may provide additional benefits in terms of long-term weight control, NASH improvement, and prevention of the progression of liver cirrhosis.
BI456906 is part of Boehringer Ingelheim's growing portfolio in obesity and NASH.
BI456906 is part of Boehringer Ingelheim's growing portfolio in obesity and NASH.
GLP-1/GCG dual agonistic effect (picture from document DOI:10.
1111/joim.
12837)
1111/joim.
12837)
BI456906 was licensed from Zealand in 2011.
Pursuant to the terms of the BI456906 license agreement, Boehringer Ingelheim funds all research, development and commercialization activities.
Zealand is eligible for outstanding milestone payments of up to 345 million euros.
The launch of Phase 2 of the study does not involve milestone payments.
If listed, Zealand is also eligible to charge high single-digit to low double-digit royalties based on global sales.
Pursuant to the terms of the BI456906 license agreement, Boehringer Ingelheim funds all research, development and commercialization activities.
Zealand is eligible for outstanding milestone payments of up to 345 million euros.
The launch of Phase 2 of the study does not involve milestone payments.
If listed, Zealand is also eligible to charge high single-digit to low double-digit royalties based on global sales.
The two obesity and NASH Phase 2 clinical trials launched this time are part of the long-term cooperation between Boehringer Ingelheim and Zealand.
Previously, a phase 2 study of BI456906 for the treatment of type 2 diabetes was launched in 2020.
Previously, a phase 2 study of BI456906 for the treatment of type 2 diabetes was launched in 2020.
The Phase 2 randomized double-blind placebo-controlled dose discovery trial (NCT04667377) will evaluate the efficacy and safety of BI456906 in obese patients or overweight patients with a body mass index ≥27 kg/m2 and no diabetes.
During the trial, patients received subcutaneous injections of BI456906 or placebo once a week.
The primary endpoint of the trial is the percentage change in body weight compared to placebo at week 46.
During the trial, patients received subcutaneous injections of BI456906 or placebo once a week.
The primary endpoint of the trial is the percentage change in body weight compared to placebo at week 46.
Another phase 2 randomized double-blind placebo-controlled dose discovery trial (NCT04771273) will evaluate the efficacy and safety of BI456906 in patients with NASH and liver fibrosis (F2/F3) with and without diabetes.
The primary endpoint of the trial is histological improvement of steatohepatitis and no worsening of fibrosis after 48 weeks of treatment.
During the trial, patients received different doses of BI456906 or placebo subcutaneously once a week.
The primary endpoint of the trial is histological improvement of steatohepatitis and no worsening of fibrosis after 48 weeks of treatment.
During the trial, patients received different doses of BI456906 or placebo subcutaneously once a week.
Dr.
Waheed Jamal, Head of Cardiovascular, Metabolic and Respiratory Medicine at Boehringer Ingelheim, said: “Our cardiometabolic research and development is working to discover new ways to treat obesity and non-alcoholic steatohepatitis (NASH) to meet There are a large number of unmet medical needs in these populations.
We are exploring some unique methods with great potential to help patients with obesity or NASH.
We believe that dual agonists are the next-generation drug candidates for weight loss and NASH improvement/cirrhosis It has a higher curative effect in prevention.
" ()
Waheed Jamal, Head of Cardiovascular, Metabolic and Respiratory Medicine at Boehringer Ingelheim, said: “Our cardiometabolic research and development is working to discover new ways to treat obesity and non-alcoholic steatohepatitis (NASH) to meet There are a large number of unmet medical needs in these populations.
We are exploring some unique methods with great potential to help patients with obesity or NASH.
We believe that dual agonists are the next-generation drug candidates for weight loss and NASH improvement/cirrhosis It has a higher curative effect in prevention.
" ()
Original source: Boehringer Ingelheim and Zealand Pharma Advance to Phase 2 Clinical Testing in NASH and Obesity
