Therapy Areas: Autoimmune
argenx reports interim data from first cohort of Phase 2 proof-of-concept efgartigimod trial
20 June 2018 -

argenx (EBR: ARGX) announced on Wednesday interim data from the first cohort of the Phase 2 proof-of-concept clinical trial for efgartigimod (ARGX-113) in pemphigus vulgaris (PV) patients.

PV is a rare and serious autoimmune disease that causes painful blisters to develop on the skin and lining of the mouth, nose, throat and genitals.

The first cohort in the Phase 2 trial consisted of six mild to moderate PV patients with no or low-dose corticosteroid therapy that were treated with efgartigimod. Out of the six patients, three reached disease control in one week, one patient reached disease control after four weeks, and the two remaining patients had disease progression.

The drug was well-tolerated in all patients and no severe or serious study drug-related adverse events were reported.

Recommendations from the Independent Data Monitoring Committee (IDMC) suggest maintaining the dose at 10 mg/kg but adjusting the dosing frequency and duration of the maintenance phase in the next cohort. As a result, the second patient cohort will dose every two weeks during the maintenance phase and two additional administrations will be added for a period of eight total weeks of maintenance, up from six weeks in the first cohort.

Login
Username:

Password:


Related Headlines