Argenx Reports Interim Data From Phase 2 Proof-of-concept Trial Of Efgartigimod

(RTTNews) - argenx (ARGX) announced interim data from the first cohort of the Phase 2 proof-of-concept clinical trial of efgartigimod (ARGX-113) in pemphigus vulgaris or PV patients.

In the first cohort of the Phase 2 trial, six mild to moderate PV patients with no or low-dose corticosteroid therapy were treated with efgartigimod. Disease control was reached in three out of six patients in one week, which was characterized by patients having signs of healing of existing lesions and the absence of new lesions forming. One patient reached disease control after four weeks.

Two patients had progression of disease. In all patients exhibiting disease control, a mean maximum reduction in Pemphigus Disease Area Index (PDAI) of 55% correlated with a mean maximum decrease in pathogenic autoantibodies levels of 57%. No meaningful anti-drug antibody signals were reported.

Efgartigimod was well-tolerated in all treated PV patients with no severe or serious study drug-related adverse events reported.

The Independent Data Monitoring Committee (IDMC) evaluated the results of the first patient cohort and determined the tolerability profile to be favorable. The IDMC recommended maintaining the dose at 10 mg/kg, but adjusted the dosing frequency and duration of the maintenance phase for the next cohort.

The second patient cohort will dose every two weeks during the maintenance phase and will add two additional administrations for a period of eight total weeks of maintenance, up from six weeks in cohort 1.