Eiger BioPharma files US IND for Pegylated Interferon Lambda for HDV infection

“Filing the US IND for Lambda in the treatment of HDV is a strategic imperative for Eiger,” said Shelly Xiong, PhD, RAC, senior vice president of regulatory affairs at Eiger. “This filing should facilitate discussions with the agency regarding potential Lambda development and registration pathways for HDV as well as expanding the programme to US investigators and US patients.”

“Over recent years, patients with chronic hepatitis B and hepatitis C have benefited from huge advances in antiviral therapy for both diseases.  Unfortunately HDV remains a large unmet medical need because of the lack of any effective therapy for this most aggressive form of viral hepatitis.  In many countries, HDV presents a real public health challenge,” said Eduardo Martins, MD, DPhil, senior vice president of liver and infectious diseases development at Eiger.  “We look forward to expanding our HDV development program to include Lambda monotherapy and potential combinations, including lonafarnib.”

LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 microgram subcutaneous injections administered weekly for 48 weeks in approximately 30-40 patients with chronic HDV.  End of treatment will be followed by a treatment-free 24-week observation period.  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 in patients with chronic HDV infection.  All patients will also be administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study.  LIMT HDV is an international study currently enrolling at sites in New Zealand, Israel and Pakistan.

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