Eiger Shares Tumble Despite Phase 3 Study Meets Primary Endpoint

Eiger BioPharmaceuticals Inc (NASDAQ:EIGR) announced topline primary Week 48 data from its Phase 3 D-LIVR study of lonafarnib in two regimens in patients with chronic Hepatitis Delta Virus (HDV).
Topline results showed that both treatment arms achieved statistical significance over the placebo in the composite primary endpoint of ≥2 log decline in HDV RNA and normalization of liver enzymes and virologic & biochemical responses.
Study participants receiving the all-oral therapy and combination therapy showed a composite response of 10.1% and 19.2%, respectively, compared to 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, vs. 7.7%.
A peginterferon alfa comparator arm was included in the study to show the contribution of the effect.
The composite response rate in the all-oral arm was comparable to the peginterferon alfa arm (10.1% vs. 9.6%). The composite response rate in the combination arm was twice that of the peginterferon alfa arm (19.2% vs. 9.6%).
Investors are probably reacting to a≥2 Log decline in HDV RNA of 32% in the combination arm versus 36.5% in the peginterferon alfa arm.
Secondary endpoints, including virologic, biochemical, and composite responses at Week 72, are being collected and are expected to be reported in mid-2023.
Price Action: EIGR shares are down 60.4% at $1.52 during the premarket session on the last check Thursday.

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