Dianthus Secures Early GO with 20 CIDP Responders, Threatening Sanofi
Dianthus confirmed 20 responders in Phase 3 CAPTIVATE CIDP trial with under 40 participants, clearing GO criteria while planning to enroll up to 256 patients and randomize 128 in Part B. This success could accelerate claseprubart’s market entry and pressure Sanofi’s existing CIDP therapies.
1. Phase 3 CAPTIVATE Trial Milestone
Dianthus confirmed 20 responders with fewer than 40 participants in open-label Part A of its Phase 3 CAPTIVATE trial for CIDP, meeting the GO criteria. An independent DSMB review recorded no related serious infections or adverse events, underscoring a best-case profile for claseprubart.
2. Implications for Sanofi’s CIDP Portfolio
The early GO decision positions claseprubart to accelerate toward market as a potential standard-of-care option, intensifying competition against Sanofi’s established CIDP treatments and narrowing the time gap to market entry.
3. Regulatory Pathway and Part B Design
Dianthus will maintain a 300 mg Q2W dose, drop the 600 mg Q2W regimen, and engage regulators to streamline trial design. Part B is set to enroll up to 256 patients with 128 randomized, aiming to expedite potential approval.