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.


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