Gilead Sciences and Nimbus Therapeutics, LLC, a Cambridge, Massachusetts, biotechnology company, have signed a definitive agreement under which Gilead will acquire Nimbus Apollo, Inc., a wholly owned subsidiary of Nimbus Therapeutics, and its acetyl-CoA carboxylase (ACC) inhibitor program. Nimbus Therapeutics will receive an upfront payment of $400 million, with the potential to receive an additional $800 million in development-related milestones over time.

The Nimbus Apollo program includes the lead candidate NDI-010976, an ACC inhibitor, and other preclinical ACC inhibitors for the treatment of non-alcoholic steatohepatitis (NASH), and for the potential treatment of hepatocellular carcinoma (HCC) and other diseases. NDI-010976 was granted fast track designation by the US Food and Drug Administration (FDA) in February 2016. NASH is a serious liver disease resulting from metabolic dysfunction associated with steatosis (fat within the liver) that can lead to inflammation, hepatocellular injury, progressive fibrosis, and cirrhosis. Affecting up to 15 million people in the United States, NASH is expected to become the leading indication for liver transplantation by 2020. ACC inhibitors target a central cause of the disease byreducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis. ACC is an enzyme with two isoforms (ACC1 and ACC2) that is involved in de novo lipogenesis (the synthesis of endogenous fatty acids) and the regulation of beta-oxidation (the process by which fatty acids are broken down at a cellular level). Inhibitors of ACC therefore have the potential to prevent production of new lipids within the liver and stimulate their breakdown. In animal models of fatty liver, ACC inhibition reduces hepatic fat content, inflammation and fibrosis (scarring), all of which are important hallmarks of NASH progression. NDI-010976 is a potent, liver-targeted, allosteric inhibitor of both ACC isoforms.

Upon completion of the acquisition, Nimbus Apollo will become a wholly owned subsidiary of Gilead. Nimbus Therapeutics will retain ownership of its other research and development subsidiaries. Gilead will be solely responsible for future development and commercialization of NDI-010976 and other ACC inhibitors.

Source: Gilead Sciences