Gilead Sciences has reported two-and-a-half-year interim analysis outcomes from a Phase III study of Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC).
The analysis revealed that 81% of individuals treated with Livdelzi achieved a composite biochemical response (CBR), indicating substantial improvements in PBC progression markers.
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The ongoing, open label ASSURE trial is assessing the therapy’s long-term efficacy and safety and is enrolling up to 500 individuals with PBC from around 160 global sites.
Participants include adults with PBC who have had an inadequate response or intolerance to ursodeoxycholic acid (UDCA).
The interim analysis included data from participants who had previously been part of Livdelzi clinical trials, as well as those from the pivotal Phase III RESPONSE study. The data revealed that 41% of subjects achieved normalisation of alkaline phosphatase (ALP) levels, a key liver function biomarker.
The safety profile of Livdelzi was highlighted with no treatment-related serious adverse events (SAEs) reported.
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By GlobalDataOver time, the incidence of adverse events per 100 patient-years decreased, demonstrating Livdelzi’s general tolerability with up to three years of exposure.
Analysis from a prespecified subgroup emphasised its efficacy and safety in individuals with PBC and compensated cirrhosis.
The analysis showed a significant decrease in ALP levels for Livdelzi-treated participants compared to those on placebo at month 12.
Additionally, a secondary analysis of pruritus in RESPONSE indicated that Livdelzi led to near resolution of itch in a significant proportion of participants, compared to none on placebo.
The company also shared findings from a large safety database, demonstrating the therapy’s tolerability over up to five years of treatment across various studies.
The exposure-adjusted incidence rates for adverse events were lower for Livdelzi compared to placebo.
Gilead Sciences Inflammation Therapeutics Clinical Development vice-president Timothy Watkins said: “Gilead has a legacy of bringing groundbreaking treatments to people in need and Livdelzi is the first and only treatment to demonstrate statistically significant and durable improvements in both pruritus and markers of cholestasis related to the risk of disease progression.
“With Livdelzi, we’ve introduced an effective and well tolerated option for people living with PBC, offering an important novel treatment option. We remain committed to advancing innovative therapies that provide real hope and improved outcomes for people facing this challenging liver disease.”
In September this year, Avenzo Therapeutics announced a clinical trial partnership with Gilead Sciences to assess a combination treatment regimen for breast cancer.
