Benzinga | Nov 1, 2021 08:20AM EDT

Eiger BioPharmaceuticals Announces Complete Enrollment Of D-LIVR, The Largest Phase 3 Study In Hepatitis Delta Virus, Investigating Lonafarnib, The Only Oral Agent In Development For HDV

Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR), a commercial-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced completion of enrollment in the Phase 3 D-LIVR study evaluating two different treatment regimens containing Lonafarnib, the Company's first-in-class oral prenylation inhibitor, for the treatment of chronic hepatitis delta virus (HDV) infection. The two regimens include all-oral Lonafarnib boosted with ritonavir and in combination with peginterferon alfa.

The D-LIVR study spans 116 clinical sites across 22 countries and is the largest Phase 3 study ever conducted in HDV. Over 400 patients have now been enrolled in D-LIVR. Eiger is planning for topline data release by the end of 2022.

"Completing enrollment of D-LIVR is a major milestone for both Eiger and patients with chronic HDV infection," said David Cory, President and CEO. "This trial is expected to generate pivotal results that will support approval of two Lonafarnib-based regimens for HDV in the U.S., 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 characterize and understand this devastating disease. We look forward to reporting data from this landmark study and bringing potential new treatment options to patients."