Gilead Sciences has announced positive results from its Phase 3 IDEAL trial evaluating Livdelzi (seladelpar)in adults with primary biliary cholangitis (PBC), a rare chronic autoimmune liver disease. The study met its primary endpoint, demonstrating statistically significant improvement in a composite measure of alkaline phosphatase (ALP) normalization compared with placebo.
The IDEAL trial was designed to assess Livdelzi in patients whose disease remained inadequately controlled despite treatment with ursodeoxycholic acid (UDCA) or who were unable to tolerate the standard therapy. Researchers focused on patients with ALP levels above the normal range but below 1.67 times the upper limit of normal, a group that has historically been underrepresented in clinical studies.
According to Gilead, treatment with Livdelzi resulted in a significantly greater proportion of patients achieving the study’s composite ALP normalization endpoint after 52 weeks of therapy. The endpoint required patients to reach normal ALP levels while also demonstrating at least a 15% reduction from baseline, an important marker associated with improved long-term outcomes in PBC.
Primary biliary cholangitis is a progressive liver disease in which the body's immune system gradually damages the bile ducts within the liver. If left uncontrolled, the condition can lead to fibrosis, cirrhosis, liver failure, and the need for liver transplantation. Experts increasingly view normalization of ALP as a meaningful treatment goal because it is linked to a lower risk of disease progression.
The latest findings add to a growing body of evidence supporting Livdelzi's role in PBC management. Previous Phase 3 studies have shown that the drug can reduce cholestatic markers, improve symptoms such as pruritus (itching), and maintain a favorable safety profile during long-term treatment.
“These results further demonstrate the potential of seladelpar to help patients achieve important biochemical treatment goals,” Gilead stated while announcing the trial outcome.
Livdelzi received regulatory approvals in several markets during the past year and is currently being evaluated in additional studies designed to assess long-term efficacy and safety. The company believes the IDEAL trial results could help expand the evidence base supporting the medicine’s use across a broader spectrum of PBC patients.
Gilead plans to present detailed findings from the IDEAL study at upcoming scientific meetings and discuss the results with regulatory authorities as part of ongoing efforts to improve treatment options for people living with this chronic liver disease.
