Dianthus unveils positive Phase II myasthenia gravis data for 8-week Claseprubart; launches DNTH212 Phase I
Dianthus Therapeutics highlighted its lead program claseprubart (DNTH103), an 8-week half-life classical pathway inhibitor showing positive Phase II myasthenia gravis results and head-to-head data suggesting superior efficacy and convenience, with 300mg subcutaneous auto-injector dosing every two or four weeks. The company initiated Phase I trials for its second candidate, DNTH212.
1. Pipeline Overview at JPMorgan Conference
At the 44th Annual J.P. Morgan Healthcare Conference, Dianthus Therapeutics CEO Marino Garcia highlighted two clinical-stage programs designed for patient-friendly subcutaneous self-administration. The lead asset, claseprubart (DNTH103), is a classical pathway inhibitor targeting activated C1s with an extended half-life of approximately eight weeks. It is formulated as a 300 mg, 2 mL auto-injector intended for dosing every two or four weeks. The second program, DNTH212, recently entered Phase I, marking the company’s expansion into complementary mechanisms for autoimmune disorders.
2. Clinical Data and Upcoming Milestones
Garcia reviewed positive Phase II proof-of-concept data for claseprubart in generalized myasthenia gravis, disclosed in September, and early clinical signals in chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy. In vitro head-to-head studies demonstrated comparable target engagement to current therapies without a boxed warning or REMS requirement. Dianthus plans to initiate a pivotal Phase III trial in MG by mid-2026 and expects topline data for DNTH212’s single ascending dose cohort by Q4 2026, positioning both programs for potential registrational pathways in 2027.