At the 44th Annual J.P. Morgan Healthcare Conference, Dianthus Therapeutics’ CEO Marino Garcia provided investors with an in-depth update on the company’s two lead clinical-stage programs, emphasizing the shift toward patient-friendly subcutaneous self-administration. The presentation highlighted the validated nature of the classical pathway inhibitor program and confirmed the initiation of a Phase I study for the second program, demonstrating Dianthus’s commitment to advancing its differentiated autoimmune portfolio.

Claseprubart, Dianthus’s flagship C1s inhibitor, features an extended eight-week half-life and is designed for a single 300 mg, 2 mL subcutaneous auto-injector dosed every two or four weeks. Positive Phase II results in generalized myasthenia gravis disclosed in September showed statistically significant improvement on the MG-ADL scale versus placebo (p<0.01), while head-to-head in vitro data against leading complement inhibitors demonstrated superior C1s target engagement with no box warning or REMS requirement. Ongoing Phase II/III planning aims to enroll over 150 patients across myasthenia gravis, CIDP and MMN cohorts by mid-2026.

Dianthus also announced the start of its first-in-human Phase I trial for DNTH212, an innovative biologic targeting FcRn to reduce pathogenic IgG levels in autoimmune disorders. The single-ascending-dose portion will evaluate safety, tolerability and pharmacokinetics in up to 60 healthy volunteers, with topline data expected in Q4 2026. This entry into early clinical development positions Dianthus to tap into a projected $5 billion FcRn inhibitor market by 2030 and further diversifies its late-stage pipeline beyond C1s inhibition.