Eiger BioPharmaceuticals has concluded subject enrolment in the Phase III D-LIVR study of its oral prenylation inhibitor, Lonafarnib, to treat chronic hepatitis delta virus (HDV) infection.
The Delta Liver Improvement and Virologic Response (D-LIVR) in HDV study enrolled more than 400 subjects and will be conducted in 116 clinical centres across 22 countries.
Lonafarnib hinders the prenylation step of HDV replication inside liver cells and blocks the lifecycle of the virus during the assembly stage.
The global, multi-centre Phase III D-LIVR study will assess two different Lonafarnib-based treatment regimens, which include all-oral Lonafarnib boosted with ritonavir, as well as in combination with peginterferon alfa.
The trial will also include a peginterferon alfa monotherapy arm that will be utilised to only show the contribution of effect.
Eiger stated that each arm will be compared with a placebo arm in patients infected with HDV.
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The study is claimed to be the largest Phase III trial conducted in HDV, which is the most severe form of human viral hepatitis.
Eiger BioPharmaceuticals president and CEO David Cory said: “Completing enrolment of D-LIVR is a major milestone for both Eiger and patients with chronic HDV infection.
“This trial is expected to generate pivotal results that will support approval of two Lonafarnib-based regimens for HDV in the US, Europe, and rest of world.
“In addition, D-LIVR is generating the single, largest source of HDV patient data from a well-controlled, global Phase 3 study to better characterise and understand this devastating disease.”
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have granted Orphan Drug designation to Lonafarnib.
The FDA also granted Breakthrough designation and Fast Track designation while EMA gave PRIME designation to the oral inhibitor.
Furthermore, the company secured an exclusive international licence to lonafarnib from Merck.