Eiger announces positive FDA guidance for hepatitis D trials

Eiger Biopharmaceuticals announced positive FDA guidance regarding the company’s Hepatitis Delta Virus program, which includes an upcoming phase 3 trial designed to evaluate lonafarnib plus ritonavir with or without pegylated interferon-alpha for the treatment of HDV, according to a press release.

“We are very pleased by the collaborative discussion with FDA and look forward to our planned advancement of the phase 3 program for chronic HDV later this year,” David Apelian, MD, PhD, chief operating officer and executive medical officer of Eiger, said in the release.

Eiger plans for the D-LIVR (Delta Liver Improvement and Virologic Response in HDV) phase 3 trial to comprise approximately 300 patients from multiple international centers and will include one arm of lonafarnib plus ritonavir with pegylated interferon-alpha, one without PEG-IFN-alpha, and one placebo arm for comparison.

According to Eiger, the FDA also supported the development of PEG-IFN lambda for HDV and Eiger plans to conduct a phase 2 study of lambda in combination with lonafarnib plus ritonavir. The study will consist of 24 weeks of treatment and an additional 24 weeks of follow-up. Eiger plans to begin enrollment in the second quarter of 2018 and the study will be conducted within the National Institutes of Health at the National Institute of Diabetes and Digestive and Kidney Diseases.

“We look forward to advancing a single pivotal trial in HDV using a lonafarnib-based regimen,” David Cory, president and CEO of Eiger, said in the press release. “We are executing on our goal to develop the first approved therapy for HDV patients, with opportunities for label expansion and increased therapeutic options in the future.” – by Talitha Bennett

Reference: www.eigerbio.com

Disclosures: Apelian and Cory are employeed by Eiger Biopharmaceuticals.