Gilead Sciences has announced that the company is stopping its mid-stage trial of the investigational monoclonal antibody simtuzumab in patients with idiopathic pulmonary fibrosis. The decision follows an analysis of unblinded efficacy and safety results by the study’s data monitoring committee (DMC), which recommended that the study be terminated because of a lack of efficacy. Gilead also reviewed the data and determined that the study did not show evidence of a treatment benefit in the group of patients randomly assigned to receive simtuzumab.
Separately, phase 2 trials of simtuzumab are ongoing in patients with nonalcoholic steatohepatitis or primary sclerosing cholangitis. The DMCs for these studies also met and recommended that studies be continued. Both studies have a 96-week endpoint.
This isn’t the first time simtuzumab has failed to meet expectations, according to the BioSpace website. In 2014, Gilead terminated a phase 2 study of simtuzumab in combination with gemcitabine in patients with pancreatic cancer when the treatment failed to significantly increase progression-free survival. The company acquired simtuzumab from Arresto Biosciences in 2011.
Gilead recently reported that two phase 3 trials of its hepatitis B drug tenofovir alafenamide (TAF) achieved their primary endpoints. TAF was shown to be noninferior to Gilead’s Viread (tenofovir disoproxil fumarate). In addition, TAF demonstrated improved renal and bone laboratory safety parameters compared with Viread, the company said.
Gilead plans to submit a new drug application for TAF in the first quarter of 2016.
Sources: Gilead Sciences; January 5, 2016; and BioSpace; January 6, 2016.