Dianthus Therapeutics Inc. (NASDAQ:DNTH) released topline data from the Phase 2 MaGic trial evaluating the safety and efficacy of claseprubart (DNTH103) in adults with acetylcholine receptor antibody-positive (AChR+) generalized myasthenia gravis (gMG).
Claseprubart 300mg and 600mg demonstrated rapid, statistically significant, and clinically meaningful improvements over placebo as measured by both MG-ADL and QMG, including at Week 1 and at Week 13.
The Myasthenia Gravis Activities of Daily Living (MG-ADL) scale is used to measure your gMG symptoms:
Claseprubart dosed at 300mg achieved a statistically significant and clinically meaningful mean improvement from baseline of 4.6 points in the MG-ADL score at Week 13 (placebo-adjusted improvement: 1.8 points; P=0.0113). A statistically significant improvement in the MG-ADL was also seen as early as Week 1 with 300mg.
Claseprubart dosed at 600mg achieved a statistically significant and clinically meaningful mean improvement from baseline of 5.4 points in the MG-ADL score at Week 13 (placebo-adjusted improvement: 2.6 points). A statistically significant improvement in the MG-ADL was also seen as early as Week 1 with 600mg.
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Quantitative Myasthenia Gravis score (QMG) measures disease severity:
At a 300mg dose, Claseprubart showed an improvement from baseline of 4.4 points in QMG score at Week 13 (placebo-adjusted improvement: 2.4; P=0.0144).
A statistically significant improvement in QMG was also seen as early as Week 1 with 300mg.
Claseprubart dosed at 600mg showed improvement from baseline of 4.5 points in QMG score at Week 13 (placebo-adjusted improvement: 2.5; P=0.0111). A statistically significant improvement in QMG was also seen as early as Week 1 with 600mg.
Claseprubart was generally well tolerated with no drug-related Serious Adverse Events (SAEs) or discontinuations due to any related adverse event.
Claseprubart had a favorable clinical safety profile comparable to placebo, with no treatment-related serious bacterial infections and no clinical symptoms of emergent autoimmune disorders observed.
Next Steps:
“2026 will be a catalyst-rich year, with the initiation of the Phase 3 gMG trial followed by results from the interim responder analysis of the Phase 3 CAPTIVATE trial in Chronic Inflammatory Demyelinating Polyneuropathy and topline results from the Phase 2 MoMeNtum trial in Multifocal Motor Neuropathy, both in 2H’26,” said Marino Garcia, President and CEO of Dianthus Therapeutics.
William Blair analyst Myles R. Minter on Monday wrote, “Today's data on claseprubart from the MaGic trial in gMG demonstrate a major proof-of-concept for Dianthus's pipeline-in-a-product in claseprubart, which is being developed across multiple autoimmune neurology indications.”
Minter has increased confidence in data from CAPTIVATE interim readout and MOMENTUM. William Blair reiterates the Outperform rating on Dianthus with impressive MaGic data.
DNTH Price Action: Dianthus Therapeutics shares were up 12.28% at $29.75 at the time of publication on Monday, according to Benzinga Pro data.
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