Shares of Dianthus Therapeutics (NASDAQ:DNTH) soared 65% following the release of positive results from its Phase 2 trial of claseprubart, an experimental therapy for generalized Myasthenia Gravis (gMG).
The company reported that both 300mg and 600mg doses of claseprubart, administered every two weeks, achieved statistically significant and clinically meaningful improvements in key efficacy measures. Patients showed better outcomes on the Myasthenia Gravis Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) scales by Week 13 compared to placebo.
Notably, improvements were observed as early as Week 1, and the 300mg dose performed comparably to the 600mg dose across primary endpoints. This supports the company’s plan for a convenient 300mg/2mL self-administered subcutaneous injection every two weeks.
“The consistent and meaningful treatment effect seen in both treatment arms across multiple standard MG efficacy metrics in this Phase 2 trial gives me and my team great confidence in our ability to execute a successful Phase 3 trial,” said Simrat Randhawa, MD, Chief Medical Officer of Dianthus Therapeutics.
The therapy demonstrated a favorable safety profile, with no serious infections, emergent autoimmune conditions, or drug-related adverse events or discontinuations reported.
The MaGic trial enrolled 65 participants who were acetylcholine receptor antibody positive (AChR+) with gMG. Its primary endpoint focused on safety and tolerability, while secondary endpoints measured improvements across multiple disease assessment scales.
Dianthus plans to meet with the FDA to align on a Phase 3 trial design evaluating both 300mg every two weeks and 300mg every four weeks dosing schedules, with initiation of the trial expected in 2026.
Dianthus Therapeutics stock price
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