EIGER BIOPHARMACEUTICALS, INC. Eiger BioPharmaceuticals, Inc. announced its decision to discontinue the Phase 3 LIMT-2 study of peginterferon lambda in patients with chronic hepatitis delta (CHD). The decision is based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review. In a communication dated September 7, 2023, the DSMB recommended the discontinuation of the LIMT-2 study due to observations of four patients with hepatobiliary events that resulted in liver decompensation.
The Phase 3 LIMT-2 study is an open-label, parallel-arm clinical trial that randomized patients with well-compensated CHD infection to one of two treatment groups: peginterferon lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=105), or no treatment for 12 weeks followed by peginterferon lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=53). In July, the trial completed enrollment of 158 patients in 12 countries across 48 investigator sites.
