Gilead Sciences will acquire a Nimbus Therapeutics wholly-owned subsidiary and its acetyl-CoA carboxylase (ACC) inhibitor program—including a Phase II-bound lead candidate—for up to $1.2 billion, the companies said today.
The deal adds to Gilead’s pipeline in liver diseases with a development program indicated for nonalcoholic steatohepatitis (NASH), as well as for the potential treatment of hepatocellular carcinoma (HCC) and other diseases.
The program includes lead candidate NDI-010976, a first-in-class allosteric ACC inhibitor of both ACC isoforms, ACC1 and ACC2, and preclinical ACC inhibitors designed to work by reducing aberrant lipid-derived signaling that can result in steatosis, inflammation, and fibrosis.
Phase I data for NDI-010976 is set to be presented next month at The International Liver Congress 2016, the annual meeting of the European Association for the Study of the Liver (EASL).
On February 2, Nimbus Therapeutics said it was on track to start Phase II clinical testing for NDI-010976 in the first half of this year. NDI-010976 was granted Fast Track designation by the FDA in February.
The preclinical candidates include ND-654, now in IND-enabling phase for HCC, and allosteric ACC inhibitors with broad distribution in the body designed to treat immune-inflammatory disorders and cancer.
“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,” Norbert Bischofberger, PhD, Gilead evp, research and development and CSO, said in a statement. “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.”
According to its website, Gilead’s pipeline already lists four NASH-indicated candidates. Three of them are in Phase II—simtuzumab, a monoclonal antibody also under development for primary sclerosing cholangitis; GS-4997, an apoptosis signal-regulating kinase 1 (ASK-1) inhibitor; and the combination of simtuzumab and GS-4997. A fourth NASH compound, the farnesoid X receptor (FXR) agonist GS-9674, is in Phase I.
Gilead agreed to pay Nimbus Therapeutics $400 million upfront for the ACC inhibitor program and subsidiary Nimbus Apollo, plus up to $800 million tied to achieving development milestones.
Upon completion of the deal, Gilead will solely oversee future development and commercialization of NDI-010976 and other ACC inhibitors. Nimbus Apollo will become a wholly-owned subsidiary of Gilead, whereas Nimbus Therapeutics will retain ownership of its other R&D subsidiaries.
Nimbus Therapeutics said the acquisition reflected the success of its use of computational chemistry to discover compounds against long-intractable disease targets. The company is structured as a series of independent C corporations, each housing R&D programs focused on a particular disease target.
“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,” added Nimbus Therapeutics CEO Don Nicholson, Ph.D.