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𝐂𝐲𝐦𝐚𝐁𝐚𝐲'𝐬 𝐒𝐞𝐥𝐚𝐝𝐞𝐥𝐩𝐚𝐫: 𝐁𝐫𝐞𝐚𝐤𝐭𝐡𝐫𝐨𝐮𝐠𝐡 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐟𝐨𝐫 𝐏𝐁𝐂 𝐏𝐮𝐛𝐥𝐢𝐬𝐡𝐞𝐝 𝐢𝐧 𝐍𝐄𝐉𝐌 The New England Journal of Medicine has published detailed results from the RESPONSE Phase 3 trial evaluating seladelpar in adults with primary biliary cholangitis (PBC). The study showed rapid and sustained improvements in reducing cholestasis, liver injury, and pruritus (itching), supporting its potential as a new treatment option. RESPONSE, a double-blind, placebo-controlled trial, demonstrated significant reductions in ALP, ALT, and GGT levels with seladelpar treatment compared to placebo, along with substantial improvements in pruritus scores across multiple scales. Dr. Gideon Hirschfield Gideon Hirschfield, Lily and Terry Horner Chair in Autoimmune Liver Disease Research, Toronto Centre for Liver Disease, emphasized the need for innovative treatments for PBC, noting the substantial benefits observed with seladelpar in the trial. Safety data showed similar profiles between seladelpar and placebo groups, with no significant safety concerns associated with seladelpar treatment. Charles McWherter, Ph.D. Charles McWherter, Ph.D., Chief Scientific Officer and President of Research and Development at CymaBay CymaBay Therapeutics, highlighted the significance of these findings and the potential for seladelpar to transform PBC treatment. With the New Drug Application accepted for priority review by the FDA, and plans for marketing authorization applications in Europe, seladelpar's journey towards regulatory approval is underway. #PBC #NEJM #ClinicalResearch #HealthcareInnovation #LiverDisease #DrugDevelopment #MedicalBreakthroughs

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