Gilead's recent acquisition of CymaBay Therapeutics continues to pay off, with the drugmaker sharing positive two-year interim results for its newly-acquired seladelpar for primary biliary cholangitis (PBC).
The ASSURE study's interim analysis included participants from the phase 3 RESPONSE study and previous trials, showing sustained and consistent long-term efficacy and safety of seladelpar. The results were presented at the European Association for the Study of the Liver Congress 2024 in Milan, Italy.
Seladelpar showed rapid and durable improvements in liver function markers and a significant reduction in pruritus (itching) for participants with moderate to severe symptoms. The analysis showed that 70% of participants from legacy studies met the composite response endpoint after 24 months, with 42% achieving normalization of alkaline phosphatase (ALP) levels, a biomarker of liver disease progression.
Gilead also revealed that the subset analysis of participants with compensated cirrhosis showed clinically meaningful improvements in markers of cholestasis and liver injury. Of the participants who completed 12 months of treatment, 56% met the composite biochemical endpoint, and 47% achieved ALP normalization.
Seladelpar is under priority review by the FDA, with an anticipated decision in August 2024, and is also being reviewed by the U.K. Medicines and Healthcare Products Regulatory Agency and the European Medicines Agency. If approved, seladelpar would offer a new option for patients who have become resistant to current treatments.
Seladelpar was key in Gilead’s recent $4.3 billion acquisition of Cymabuy. According to LSEG data, seladelpar has the potential to generate sales of $1.9 billion by 2029.
