Gilead Sciences, and Nimbus Therapeutics, LLC have announced that the companies 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.
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 U.S. Food and Drug Administration (FDA) in February 2016 and Phase 1 data for the compound will be presented next month during an oral session at The International Liver Congress 2016, the annual meeting of the European Association for the Study of the Liver (EASL).
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 – reducing aberrant lipid-derived signaling that can result in steatosis, inflammation and fibrosis.
“The acquisition of Nimbus’ ACC-inhibitor program represents a timely and important opportunity to accelerate Gilead’s ongoing efforts to address unmet needs in NASH,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “These molecules will complement and further strengthen Gilead’s pipeline and capabilities to advance a broad clinical program in NASH that includes compounds targeting multiple key pathways involved in the pathogenesis of the disease.”
“Given the company’s long-standing commitment to and expertise in liver disease, we are confident that Gilead is the ideal partner to accelerate and maximize the potential of the ACC inhibitor program,” said Don Nicholson, PhD, Chief Executive Officer of Nimbus Therapeutics. “This agreement underscores Nimbus’ ability to rapidly discover, design and optimize promising therapeutics in areas of unmet need, an approach we will continue to apply against other medically important targets.”
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.