Eiger BioPharmaceuticals announced the receipt of written guidance from the FDA, confirming concurrence on a pivotal trial design, including the primary endpoint for D-LIVR, the first-ever, registration study for Hepatitis Delta Virus (HDV) infection.
A combined primary endpoint of ≥ 2 log10 decline in HDV RNA and normalization of alanine aminotransferase (ALT) at the end of 48 weeks of treatment has been accepted by the FDA as the primary endpoint and would be supportive of an accelerated approval of two lonafarnib-based, ritonavir-boosted regimens. An all-oral arm of lonafarnib boosted with ritonavir and a combination arm of lonafarnib boosted with ritonavir combined with pegylated interferon-alfa will each be compared to placebo in the D-LIVR study. Accelerated approval could be based on successful achievement of this surrogate endpoint in this single pivotal study in addition to a post-marketing confirmatory trial to evaluate clinical benefit.
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"We are very pleased with FDA acceptance of a combined endpoint of ≥ 2 log10 decline in HDV RNA and ALT normalization for the Phase 3 D-LIVR study and believe it serves as an excellent primary efficacy endpoint to support the accelerated approval of lonafarnib-based regimens for HDV," said David Apelian, MD, PhD, MBA, Chief Operating Officer and Executive Medical Officer. "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."
"HDV prevalence estimates in the U.S. and Western Europe now exceed a combined 300,000 infected, and 15-20 million in the rest of the world, with no approved treatment, making this a very large commercial opportunity," said David Cory, President and Chief Executive Officer. "The Phase 3 D-LIVR protocol is now finalized based on these recent discussions with FDA and will include two separate lonafarnib-based regimens, each to be compared to placebo, in a single pivotal trial. Eiger is about to begin the first-ever, registration trial with the potential to bring two separate, approved