Boehringer Ingelheim expands NASH R&D pipeline with new first-in-class compound

Yuhan Corporation to receive up to USD 870 million in upfront and success-based development and commercialization milestones, excluding royalties.

NASH often starts with the accumulation of fat in the liver, giving rise to inflammation and finally leading in many patients to liver fibrosis and cirrhosis. It has an especially high prevalence among obese and diabetic patients and is an area of high unmet medical need with no treatments currently available. Boehringer Ingelheim believes that in many cases approaches targeting one of the features of NASH will not be able to achieve the desired resolution of NASH in patients with advanced stages of the disease. Thus Boehringer Ingelheim has built a comprehensive program to develop next-generation therapy approaches targeting all three key drivers of the disease - steatosis, inflammation and fibrosis.

Preclinical evidence suggests high efficacy when combining the gut-derived hormone GLP-1 with FGF21. The dual agonist (GLP1R/FGF21R agonist) is expected to reduce liver cell injury and hepatic inflammation by resolution of steatohepatitis as well as having direct antifibrotic effects and complements Boehringer Ingelheim’s R&D portfolio in NASH adding another potential first-in-class opportunity.

“We are excited about this new opportunity which adds to our longstanding and successful partnership with Yuhan Corporation,” says Dr Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the Innovation Unit. “This partnership brings us closer to next-generation treatments for patients with NASH,” adds Pairet.

”We look forward to working jointly with Boehringer Ingelheim, with its strong track record of bringing new treatments to patients with cardiometabolic disease. Boehringer Ingelheim’s clinical expertise will now be applied to the development of this drug which has the potential to make a real difference for patients with NASH,” says Jung Hee Lee, CEO and President at Yuhan Corporation. “This molecule, which is a fusion protein utilizing the long-acting (HyFc) technology of Genexine, has been developed in-house by Yuhan Corporation. Not only is our collaboration with Boehringer Ingelheim on this molecule Yuhan’s first external partnership with biologics, it is also the very first out-licensing of biologics targeting NASH from Korea,” adds Mr. Lee.