Eiger BioPharmaceuticals Announces First Patient Enrolled in LIMT-2: A Phase 3 Study of Peginterferon Lambda in Patients with Chronic Hepatitis Delta Virus (HDV) Infection
"LIMT-2 is a single pivotal study to support approval of Peginterferon Lambda for the treatment of HDV," said
"There are now multiple late-stage, promising investigational treatments in development for HDV, each with a different mechanism of action and formulation for different routes of administration," said Pietro Lampertico, MD, PhD, LIMT-2 Principal Investigator, Professor of Gastroenterology, Director of the Gastroenterology and Hepatology Division, and Head of the "A. M. e A. Migliavacca" Center for Liver Disease at the Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of
About Phase 3 LIMT-2 Study
LIMT-2 is a randomized, open-label, parallel-arm study that will randomize patients with chronic HDV infection to one of two treatment groups, applying a 2:1 allocation ratio: Peginterferon Lambda 180 mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=100), or no treatment for 12 weeks followed by Peginterferon Lambda treatment for 48 weeks with 24 weeks of follow-up (Arm 2, n=50). All patients will receive tenofovir or entecavir throughout the study duration.
The primary analysis will compare the proportion of patients with a Durable Virologic Response (DVR), defined as HDV RNA below the limit of quantitation (BLQ) at 24-weeks post-treatment in the Peginterferon Lambda treatment group (Arm 1) to the proportion of patients with HDV RNA BLQ after 12 weeks of no treatment in the comparator group (Arm 2). This post-treatment DVR endpoint is most meaningful for both regulatory agencies and physicians as it demonstrates durability of response to treatment and potential for an HDV cure. Approximately 150 patients will be enrolled in 13 countries across 50 investigator sites.
About Peginterferon Lambda
Peginterferon Lambda is a well-characterized, late-stage, first-in-class, type III interferon (IFN) that stimulates immune responses that are critical for the development of host protection during viral infections. Peginterferon Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa, resulting in activation of the same Jak-STAT signal transduction cascade. Lambda type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which may reduce off-target effects and improve tolerability of Peginterferon Lambda.
In Phase 2, Peginterferon Lambda was dosed once weekly in HDV infected patients for 48 weeks with 24-week follow-up. 36% of patients who received Peginterferon Lambda achieved a DVR.
About Hepatitis Delta Virus (HDV)
HDV is the most severe form of human viral hepatitis. HDV occurs only as a co-infection in individuals infected with hepatitis B virus (HBV). HDV leads to more severe liver disease than HBV alone and is associated with accelerated liver fibrosis, liver cancer, and liver failure. It is estimated that 60% of HDV infected patients die within ten years. Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not affect HBsAg and have no impact on HDV.
HDV is a disease with a significant impact on global health, which may affect greater than 12 million people worldwide. Globally, HDV infection is reported to be present in approximately 5% of patients with chronic HBV.
About
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; the ability to activate sites and fully enroll the Phase 3 LIMT-2 study; the potential of Peginterferon Lambda to be an effective therapy for HDV; and the generation of clinical trial data to support its submission for regulatory approval. Various important factors could cause actual results or events to differ materially from the forward-looking statements that
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