Business
Dianthus Therapeutics Announces Early GO Decision Following Interim Responder Analysis in Phase 3 CAPTIVATE Trial of Claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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
About this update from Dianthus Therapeutics, Inc.
[{"type":"text","content":"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 Investor conference call and webcast to be held today, March 9, 2026 at 8:00 a.m. ET NEW YORK and WALTHAM, Mass., March 09, 2026 (GLOBE NEWSWIRE) -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced an early GO decision based on an interim responder analysis in the Phase 3 CAPTIVATE trial of claseprubart in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). “We are excited to announce an early GO decision based on results from less than 40 planned participants completing Part A of the CAPTIVATE Phase 3 trial. These interim responder analysis results, in addition to the robust Phase 2 data from our MaGic trial in generalized Myasthenia Gravis, bolster our confidence in the best-in-class target profile for claseprubart and its potential to become a best-in-disease, first-line biologic of choice across a range of large and growing neuromuscular indications,” said Marino Garcia, Chief Executive Officer of Dianthus. “Classical pathway inhibition could replace the standard of care in the multi-billion-dollar CIDP market with the potential for improved efficacy, differentiated safety, and lower patient burden. We expect our planned study design changes to streamline the CAPTIVATE trial and support even faster execution.” Interim Responder Analysis Results Summary The target for the Part A interim responder analysis was a response rate of ...