Dianthus Therapeutics Announces An Early GO Decision Based On An Interim Responder Analysis In The Phase 3 CAPTIVATE Trial Of Claseprubart In Chronic Inflammatory Demyelinating Polyneuropathy
Benzinga Newsdesk 8 months ago
BiotechHealth CareGeneral
Early GO decision reached ahead of Q2'26 guidance based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A Key objectives achieved: Company will
- Early GO decision reached ahead of Q2'26 guidance based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A
- Key objectives achieved: Company will maintain the Part A dose of 300mg/2mL S.C. Q2W, plans to engage with regulators to remove the 600mg/4mL S.C. Q2W dose arm from Part B, and expects to enroll up to 256 patients in Part A to randomize 128 patients in Part B
- Independent DSMB review confirmed GO decision; no related serious infections, no clinical symptoms of autoimmune activation, and no related serious adverse events or discontinuations
- GO decision supports continued development of claseprubart 300mg/2mL Q2W S.C. in CIDP, targeting a potentially best-in-disease biologic profile across a broad population of CIDP patients, including those refractory to standard-of-care