Gilead’s drug boosted by positive Phase II trials and aims to move forward

pharmafile | October 21, 2016 | News story | Medical Communications Gilead, Gilead Sciences, clinical trials, fatty liver disease 

Gilead Sciences has announced positive results from three Phase II studies upon their drug GS-4997, otherwise known as selonsertib. The drug treats fatty liver disease, which is more commonly known as NASH (non-alcoholic steatohepatitis. The drug was tested alone and alongside Gilead’s experimental anti-fibrotic drug simtuzumab. The treatment was found to reduce liver scarring in the mid-stage trial.

The results showed that 43% of patients saw improvement on an 18mg of selonsertib, with only 3% progressing to cirrhosis. The results were found not to differ whether anti-fibrotic drug simtuzumab was introduced or not. Selonsertib was administered daily via an oral dose. Due to the positive results, Phase III clinical trials are already being planned.

“We are committed to advancing our pipeline of investigational molecules that separately target metabolic dysfunction, inflammation and/or fibrosis associated with NASH,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We are encouraged by these data demonstrating the anti-fibrotic effect of GS-4997 in patients with NASH after only 24 weeks of treatment, and look forward to sharing the complete results with the hepatology community. Additionally, pending discussions with regulatory agencies, we plan to initiate a Phase 3 clinical trial program of GS-4997 in patients with NASH.”

The drug was also being tested in Phase II to ascertain whether it could be an effective treatment for pulmonary arterial hypertension and diabetic kidney disease. However, the data from their Phase II trials saw the drug fail to reach the primary endpoints for these indications.

 Ben Hargreaves

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