Eiger BioPharmaceuticals has received the Notice of Allowance from the United States Patent and Trademark Office (USPTO) for U.S. patent application number 15/335,327, entitled "Treatment of Hepatitis Delta Virus Infection." The allowed claims cover a broad range of ritonavir (RTV)-boosted lonafarnib (LNF) doses and durations. Lonafarnib is an oral, small molecule farnesyl transferase inhibitor in development for the treatment of hepatitis delta virus (HDV) infection.
This Notice of Allowance concludes substantive examination of the patent application and after administrative processes are completed, is expected to result in the issuance of a U.S. patent with a term extending to 2035. Additional claims are being pursued in continuation applications.
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"This method of use patent covers a range of ritonavir-boosted lonafarnib doses and durations, including specific doses that we anticipate will appear on the first label of lonafarnib for treatment of hepatitis delta virus infection," said David Cory, President and CEO of Eiger. "This patent allowance is especially timely as we finalize the protocol for our single, pivotal registration study, D-LIVR, which we plan to initiate later this year."
Lonafarnib is a well-characterized, late-stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the virus life cycle at the stage of assembly. Lonafarnib has been dosed in over 120 HDV-infected patients across international academic centers and is advancing into Phase 3 with a single, pivotal trial (D-LIVR Study) planned to initiate by the end of 2018. Lonafarnib has been granted Orphan Drug Designation by the U.S. FDA and European Medicines Agency (EMA), and Fast Track Designation by U.S. FDA. Lonafarnib is not approved for any indication and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada).