CymaBay announced that The New England Journal of Medicine – NEJM – has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar, an investigational agent, and the only potent, selective peroxisome proliferator-activated receptor delta agonist or delpar, being studied in adults with primary biliary cholangitis – PBC -. Results showed rapid and sustained improvements in reducing cholestasis and liver injury, together with significant reductions in pruritus. The primary endpoint was a composite of ALP and total bilirubin at Month 12, which supported authorization for current second line treatment in PBC by the FDA and EMA for registrational studies in PBC. The primary endpoint was achieved in 61.7% of patients treated with seladelpar vs. 20.0% treated with placebo. The key secondary endpoint of ALP normalization was reached in 25.0% of patients treated with seladelpar vs. 0.0% for patients treated with placebo. The study also measured change in patient-reported pruritus as a key secondary endpoint. Improvement in pruritus was seen as soon as Week 4 and significance achieved at Month 6 among patients with baseline NRS greater than 4 reporting decreases of 3.2 points with seladelpar vs. 1.7 for patients on placebo. Similar results demonstrating reductions in itch and improvements in sleep were observed using the PBC-40 questionnaire. Safety was similar in the seladelpar-treated and placebo-treated groups. A New Drug Application for seladelpar for the treatment of primary biliary cholangitis was accepted for priority review by the FDA in February 2024. The company also plans to file marketing authorization applications in the first half of 2024 with the EMA where seladelpar has received Priority Medicines status and plans to file with the U.K. Medicines and Healthcare products Regulatory Agency.
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