Cudetaxestat is well tolerated and leads to no treatment-related serious adverse events when coadministered with pirfenidone or nintedanib in healthy volunteers, according to the results of a phase 1 clinical trial. There were also no drug-drug interactions with cudetaxestat plus pirfenidone or nintedanib. These results were presented at the American Thoracic Society 2022 International Conference.
Pirfenidone or nintedanib are treatments approved by the US Food and Drug Administration for patients with idiopathic pulmonary fibrosis (IPF). Cudetaxestat is a noncompetitive autotaxin inhibitor being developed for the treatment of IPF as well as other fibrotic diseases.
“These positive results from clinical and preclinical drug-drug interaction studies reinforce our confidence in the potential to co-administer cudetaxestat on top of currently approved IPF therapies in clinical studies of patients with IPF,” Wendye Robbins, MD, president and chief executive officer of Blade Therapeutics, said in a press release.
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The phase 1, open-label, nonrandomized trial assessed the effect of 750 mg of cudetaxestat on the pharmacokinetics of pirfenidone and nintedanib in 83 healthy volunteers.
The results showed that neither nintedanib nor pirfenidone significantly altered cudetaxestat exposure. Moreover, cudetaxestat did not affect the pharmacokinetics of pirfenidone nor did it significantly increase the exposure of nintedanib.
The most common treatment-related adverse events were mild gastrointestinal problems including nausea and diarrhea. However, there were no treatment-related serious adverse events. The preclinical study in a rat model assessed the effect of cudetaxestat and another investigational competitive autotaxin inhibitor, ziritaxestat, on the plasma concentration of nintedanib.
While ziritaxestat significantly increased nintedanib exposure, cudetaxestat did not. Based on these findings, Blade plans to start a phase 2 clinical trial of cudetaxestat in patients with IPF either on its own or with pirfenidone or nintedanib.
Blade Therapeutics presents data from phase 1 and preclinical studies of cudetaxestat at the American Thoracic Society 2022 International Conference. News release. Blade Therapeutics; May 16, 2022.
Dedicated drug-drug interaction (DDI) study in healthy volunteers. US National Library of Medicine. Updated April 15, 2022. Accessed May 23, 2022.