24 October 2017 - - Palo Alto, California-based rare disease therapeutics developer Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) presented positive interim 24-week data with pegylated interferon lambda (Lambda) in the Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) Study at the American Association for the Study of Liver Diseases (AASLD) meeting in Washington DC, the company said.
LIMT HDV, an international study with sites in New Zealand, Israel and Pakistan, is a 1: 1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in 33 patients with chronic HDV.
The primary objective of the phase 2 study is to evaluate the safety, tolerability, and efficacy of treatment with two dose levels of Lambda monotherapy.
All patients are administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study.
At the 24-week analysis, 10 of 33 patients had reached 24 weeks of treatment; 5 of 10 patients achieved ≥ 2 log decline in HDV RNA; 5 of 10 patients achieved HDV PCR-negativity. Additionally, Lambda is well tolerated in the majority of patients through week 24.
Lambda targets type III IFN receptors, distinct from the type I IFN receptors targeted by IFN alfa, that are highly expressed on hepatocytes. With limited expression on hematopoietic and central nervous system cells, Lambda may reduce off-target effects and improve tolerability.
Lambda has been administered in HBV / HCV clinical trials involving over 3,000 subjects. IT has not been approved for any indication. Eiger has received Orphan Designation and Fast Track Designation for Lambda in HDV.
Eiger is a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for orphan diseases.
Through the repurposing of drugs for orphan diseases, the company's mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients.