- Eiger BioPharmaceuticals Inc 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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