Eiger BioPharma’s lonafarnib meets endpoints in Phase 3 HDV trial

Eiger BioPharmaceuticals announced topline primary Week 48 data from its Phase 3 D-LIVR study evaluating lonafarnib, a first-in-class prenylation inhibitor, in two regimens in patients with chronic Hepatitis Delta Virus, or HDV: lonafarnib boosted with ritonavir alone and in combination with peginterferon alfa – combination -. The composite primary endpoint was a greater than or equal to2 log decline in HDV RNA and normalization of alanine aminotransferase at the end of 48 weeks of treatment compared to placebo. Topline Week 48 results showed that both treatment arms achieved statistical significance over placebo in the composite primary endpoint as well as the component virologic and biochemical responses. Study participants receiving the all-oral therapy and combination therapy showed a composite response of 10.1% and 19.2% respectively vs. those receiving placebo – 1.9% -. Study participants receiving the all-oral therapy and combination therapy showed statistically significant improved rates of ALT normalization of 24.7% and 34.4% respectively, compared to those receiving placebo – 7.7% -. The key secondary histological endpoint was defined as greater than or equal to 2-point improvement in histological activity index and no worsening of Ishak fibrosis scoring. This was demonstrated in 35 of 66 patients with statistical significance in the combination arm versus 8 of 30 patients – 27% – receiving placebo. Response was demonstrated in 35 of 107 patients in the all-oral arm versus placebo. Response in the peginterferon alfa comparator arm was 10 of 26 patients. Remaining secondary endpoints are being collected and are expected to be reported mid-2023. The majority of treatment emergent adverse events were mild or moderate in severity. The most frequent TEAEs associated with lonafarnib treatment were gastrointestinal. Eiger plans to engage with regulatory agencies, beginning with a pre-NDA meeting with FDA anticipated in Q1 2023, to discuss pathways for regulatory submissions.