Eiger BioPharmaceuticals Announces FDA Breakthrough Therapy Designation for Pegylated Interferon Lambda for Hepatitis D Virus Infection

On August 20, 2019, VCBeat (WeChat ID: vcbeat) learned from foreign media reports that Eiger BioPharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Therapy Designation to pegylated interferon lambda for the treatment of hepatitis D virus (HDV) infection.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs for serious diseases, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on clinically significant endpoints. This Breakthrough Therapy designation is based on the performance observed in 33 patients with HDV infection enrolled in Lambda’s Phase 2 LIMT (Lambda Interferon Mono Therapy) clinical trial.

Lambda is a type III interferon that interferes with viral replication by inducing host cells to produce various enzymes, activates immune cells, and thereby exerts antiviral effects. Lambda has previously undergone clinical trials in more than 3,000 patients.

Lambda has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and has been awarded Breakthrough Therapy and Fast Track designations by the U.S. FDA. Lambda is an investigational agent that has not yet been approved for any indication. Lambda is primarily intended for the treatment of HDV, the most severe form of viral hepatitis in humans, for which there is currently no standard of care.

Hepatitis D is a disease with significant impact on global health, potentially affecting up to 15 to 20 million people worldwide. The prevalence of HDV varies across different regions of the world.

Hepatitis D Virus (HDV) is a defective virus that cannot cause disease through single infection in humans. Because the virus itself cannot replicate or proliferate independently, it must rely on the assistance of HBV or other hepatotropic DNA viruses to provide its envelope and assembly support for replication and human infection. This means that an individual cannot contract hepatitis D alone; infection necessarily occurs either as a simultaneous co-infection with hepatitis B virus or as a sequential superinfection.

Clinically, co-infection with two viruses is occasionally observed in the same patient. Hepatitis D virus (HDV) infection invariably occurs in the presence of hepatitis B virus (HBV) infection; conversely, HBV infection does not necessarily entail HDV infection. However, because hepatitis B is more prevalent in clinical practice, it often masks or leads to missed diagnoses of hepatitis D, resulting in a low clinical diagnosis rate. According to reports, approximately 4.3% to 5.7% of chronic hepatitis B carriers worldwide are infected with HDV.

Mr. David Cory, President and Chief Executive Officer of Eiger, stated, “This Breakthrough Therapy Designation is the fourth such designation received by the Company. We look forward to collaborating with the FDA to accelerate the development programs for our four Breakthrough Therapy Designations, including the use of lonafarnib and Lambda for the treatment of hepatitis D.”

Eiger, founded in 2008 and headquartered in California, USA, is a clinical-stage biopharmaceutical company dedicated to providing innovative products for the treatment of rare diseases. The company has established a diverse portfolio of distinctive product candidates that have the potential to offer new therapeutic options for diseases with unmet medical needs, well-understood biology, and an urgent need for innovative therapies.

(Compiled by Cheng Tao)