Eiger BioPharmaceuticals receive FDA guidance for HDV study
September 24, 2018
Eiger BioPharmaceuticals received written guidance from the FDA for the “D-LIVR” phase 3 study of lonafarnib for patients with hepatitis D, according to a press release.
The guidance confirmed concurrence with the study’s primary endpoint of 2 log10 or more decline in HDV RNA and alanine aminotransferase normalization at 48 weeks.
“This endpoint reflects an improvement in liver condition and virologic response rarely observed in untreated HDV patients, and we have previously demonstrated achievement of this combined endpoint in a substantial number of HDV patients with lonafarnib-based regimens in our phase 2 program,” David Apelian, MD, PhD, MBA, chief operating officer and executive medical officer of Eiger, said in the release.
Patients in the D-LIVR study will receive either all-oral lonafarnib boosted with Norvir (AbbVie, ritonavir) or lonafarnib with ritonavir and pegylated interferon-alfa. The researchers will compare outcomes with an additional placebo arm.
“Eiger is about to begin the first-ever, registration trial with the potential to bring two separate, approved treatment options to HDV patients,” David Cory, president and CEO of Eiger, noted in the release.
The U.S. FDA and European Medicines Agency previously granted orphan drug designation for lonafarnib, and the FDA granted a fast track designation.