Core Insights - Dianthus Therapeutics announced an early GO decision based on interim responder analysis in the Phase 3 CAPTIVATE trial for claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [1][2] - The decision was supported by an independent DSMB review, confirming no serious infections or adverse events related to the treatment [1][5] Trial Design and Objectives - The CAPTIVATE trial consists of two parts, with Part A involving a loading dose followed by 300mg claseprubart administered subcutaneously every two weeks for up to 13 weeks [6] - The target for the interim responder analysis was a response rate of 50% or greater, achieved with 20 confirmed responders from less than 40 participants completing Part A [5][6] - The company plans to enroll up to 256 patients in Part A, down from a previous target of 480, to randomize 128 patients in Part B [5] Future Plans and Market Potential - The company aims to engage with regulators to remove the 600mg dose arm from Part B and expects to provide top-line guidance for Part B by the end of 2026 [5][6] - The CEO expressed confidence that classical pathway inhibition could replace the standard of care in the multi-billion-dollar CIDP market, highlighting improved efficacy and safety [2] - Dianthus is also planning to initiate a Phase 3 trial in generalized Myasthenia Gravis in mid-2026, with top-line results expected in the second half of 2028 [9]