A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug's ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC).
In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial's primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday.
The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.
The patient pool in the trial included only those with an incomplete response or intolerance to ursodeoxycholic acid (UDCA), the standard first-line treatment for PBC. UDCA treatments replace bile acids, slowing disease progression and improving liver function.
“These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67,” Cynthia Levy, M.D., of the University of Miami Miller School of Medicine, said in a release.
Gilead said it will provide full results from the trial at a future medical meeting and engage with global regulators on the data.
