argenx reports positive topline results from Phase 2
The data showed a clinically meaningful and statistically significant benefit of ARGX-113 over placebo. In addition, ARGX-113 was found to have a favorable tolerability profile consistent with that observed in the Phase 1 study.
“These data demonstrate a rapid and sustained benefit in disease score after treatment with ARGX-113, supporting further development of the drug as a potential new option to fill the current treatment gap for MG patients.”
The Phase 2 double-blind, placebo-controlled, proof-of-concept trial enrolled 24 MG patients with generalized muscle weakness.
The primary endpoints of the study were safety and tolerability.
Primary endpoint analysis revealed ARGX-113 to be well tolerated in all patients.
The secondary endpoint measures relating to efficacy showed ARGX-113 treatment resulted in rapid onset of action and strong clinical improvement over placebo during the entire duration of the study.
75% of patients treated with ARGX-113 had a clinically meaningful and statistically significant improvement.
Patients in the treatment arm showed rapid disease improvement, with clear separation from placebo 1 week after the first infusion.
ARGX-113 demonstrated strong clinical improvement over placebo as measured by all four predefined clinical efficacy scales.
argenx.com/en-GB/news-internal/argenx-reports-positive-topline-results-from-phase-2-proof-of-concept-trial-of-argx-113-efgartigimod-in-generalized-myasthenia-gravis/30166/
“These data demonstrate a rapid and sustained benefit in disease score after treatment with ARGX-113, supporting further development of the drug as a potential new option to fill the current treatment gap for MG patients.”
The Phase 2 double-blind, placebo-controlled, proof-of-concept trial enrolled 24 MG patients with generalized muscle weakness.
The primary endpoints of the study were safety and tolerability.
Primary endpoint analysis revealed ARGX-113 to be well tolerated in all patients.
The secondary endpoint measures relating to efficacy showed ARGX-113 treatment resulted in rapid onset of action and strong clinical improvement over placebo during the entire duration of the study.
75% of patients treated with ARGX-113 had a clinically meaningful and statistically significant improvement.
Patients in the treatment arm showed rapid disease improvement, with clear separation from placebo 1 week after the first infusion.
ARGX-113 demonstrated strong clinical improvement over placebo as measured by all four predefined clinical efficacy scales.
argenx.com/en-GB/news-internal/argenx-reports-positive-topline-results-from-phase-2-proof-of-concept-trial-of-argx-113-efgartigimod-in-generalized-myasthenia-gravis/30166/
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