Gilead liver disease drug shows promise in interim analysis

Gilead Sciences' acquisition of CymaBay Therapeutics continues to yield positive results, particularly with the drug seladelpar for treating primary biliary cholangitis (PBC). The pharmaceutical company recently shared encouraging interim findings from a two-year analysis of seladelpar’s efficacy and safety.

The interim analysis, part of the ASSURE study, integrated data from the phase 3 RESPONSE study and previous clinical trials. These findings showed that seladelpar consistently improved liver function and reduced itching, a common and debilitating symptom of PBC. Results were presented at the European Association for the Study of the Liver Congress 2024 in Milan, Italy.

One of the key findings was the significant and lasting improvement in liver function markers among participants. Among those from earlier studies, 70% met the composite response endpoint after 24 months of treatment. Additionally, 42% of these participants achieved normalization of alkaline phosphatase (ALP) levels, a critical biomarker for liver disease progression.

Further analysis focused on participants with compensated cirrhosis, revealing clinically significant improvements in markers of cholestasis and liver injury. At the 12-month mark, 56% of these patients met the composite biochemical endpoint, and 47% achieved normalization of ALP levels.

Seladelpar is currently under priority review by the FDA, with a decision anticipated in August 2024. It is also being evaluated by the U.K. Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency. If approved, seladelpar would provide a much-needed alternative for patients who have become resistant to existing treatments.

This drug played a crucial role in Gilead's $4.3 billion acquisition of CymaBay Therapeutics. According to LSEG data, seladelpar could potentially generate $1.9 billion in sales by 2029, highlighting its significant market potential.

Overall, the recent findings underscore the promise of seladelpar as a new treatment option for PBC, reinforcing the strategic value of Gilead's acquisition of CymaBay. The positive interim results bolster confidence in seladelpar’s long-term efficacy and safety, offering hope for patients with this chronic liver disease.