Nimbus initiates Phase I clinical programme for NDI-010976 for the treatment of NASH
Posted: 22 April 2015 |
Nimbus Therapeutics has initiated a Phase I clinical programme for NDI-010976 for the treatment of NASH and related fatty liver disease-spectrum disorders…
Nimbus Therapeutics has initiated a Phase I clinical programme for NDI-010976, an allosteric Acetyl CoA Carboxylase (ACC) inhibitor, for the treatment of non-alcoholic steatohepatitis (NASH) and related fatty liver disease-spectrum disorders.
The single site, open-label Phase I study is being conducted in healthy human volunteers to assess the safety, pharmacokinetic (PK) behaviour and maximum tolerated dose of NDI-010976. A subsequent Phase Ib study will enroll obese patients with metabolic syndrome in order to measure key pharmacodynamic (PD) markers that are relevant to the NASH patient population. Nimbus expects all Phase I studies will be completed this year and Phase II studies will begin early next year.
NDI-010976 is the first liver-targeted allosteric inhibitor of ACC intended for the treatment of NASH
“We believe that ACC inhibition offers a potentially novel and important approach to the treatment of NASH and related disorders since it precisely targets a key enzyme which is required for the formation of lipids that accumulate in the liver during NASH that drive pathogenesis of the disease,” said Don Nicholson, Ph.D., Chief Executive Officer at Nimbus. “Furthermore, our preclinical data demonstrate that the effects of ACC inhibition extend to reducing inflammation and limiting fibrosis, which are hallmarks of NASH progression. We look forward to sharing these data with the scientific and medical community as we progress NDI-010976 through clinical development.”
NDI-010976 represents the first liver-targeted allosteric inhibitor of ACC intended for the treatment of NASH, an increasingly common, serious liver disease which is estimated to affect 16 million Americans. NASH can lead to liver cirrhosis, often resulting in the need for a liver transplant, as well as other complications including hepatocellular carcinoma (HCC), a liver cancer with high mortality rates. Currently there are no therapies specifically approved to treat NASH, and limited options for patients with advanced HCC, and there are no other ACC inhibitors publicly disclosed to be in development for these diseases. In addition to NDI-010976, Nimbus is continuing to advance a pipeline of novel small molecules, including those for IRAK4, Tyk2, KRas and other medically important targets.