Rare-disease-focused biotech Eiger BioPharmaceuticals ( NASDAQ: EIGR ) fell 70% pre-market Thursday after announcing topline data from its Phase 3 D-LIVR study for lonafarnib a therapeutic candidate for chronic infections with hepatitis delta virus (HDV).
The 407-patient study trial was designed to evaluate lonafarnib in two regimens: in combination with antiviral ritonavir alone (oral therapy) and in combination therapy with interferon peginterferon alfa (combination therapy).
Week 48 results indicated that both treatment arms reached statistical significance over placebo in terms of the composite primary endpoint as well as virologic and biochemical responses, the company said.
The all-oral therapy and combination therapy arms indicated composite response of 10.1% (p=0.0044) and 19.2% (p <0.0001), respectively, compared to 1.9% in the placebo arm. The groups also demonstrated ALT normalization with statistically significant improvements of 24.7% (p=0.003) and 34.4% (p<0.0001), respectively, compared to 7.7% in the placebo group.
A peginterferon alfa comparator arm, which was added to show the contribution of effect, indicated a 9.6% of composite response rate.
However, 9% and 8% of patients in the lonafarnib oral and combination therapy arms discontinued treatment, compared to 2% each in the peginterferon alfa and placebo groups, respectively.
Meanwhile, 8% and 14% of patients in oral and combination therapy arms reported treatment-emergent severe adverse events, compared to 10% and 4% in the peginterferon alfa and placebo groups, respectively.
Notably, there were two deaths in the study: One in the lonafarnib/ritonavir arm, which was unrelated to the study drug, and another in the peginterferon alfa group.
The company expects to meet the FDA in a pre-NDA meeting in Q1 2023, seeking potential regulatory submissions. The data are yet to undergo peer review.
In March, Eiger ( EIGR ) said that ongoing war would not disrupt the D-LIVR study, which included trial sites in Russia and Ukraine.
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Eiger plunges 70% after late-stage data for chronic hepatitis candidate