Eiger BioPharmaceuticals Announces Positive Phase 2 LIMT Study End of Treatment Data with Pegylated Interferon Lambda Monotherapy in Hepatitis Delta Virus (HDV) Infection
- Lambda Antiviral Activity Demonstrated in HDV Infection
- Currently Dosing Lambda in Combination with Lonafarnib in HDV Infection
Eiger BioPharmaceuticals (PRNewsFoto/Eiger BioPharmaceuticals, Inc.)
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PALO ALTO, Calif., Oct. 17, 2018 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc., (NASDAQ: EIGR) today announced positive data with Pegylated Interferon Lambda (Lambda) in the Phase 2 LIMT HDV (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) Study. LIMT HDV enrolled a total of 33 patients, randomized to Lambda 180 μg (N=16) or Lambda 120 μg (N=17), respectively, with weekly subcutaneous injections for 48 weeks in patients with chronic HDV. Lambda is a first in class, type III interferon, in development for the treatment of HDV.
At Week 48, patients in the 180 μg Lambda treated group experienced a -2.4 log10 mean decline in HDV-RNA, with 6 of 10 (60%) experiencing ≥2 log10 decline, 4 of 10 (40%) patients were HDV-RNA negative at end of treatment. At Week 48, patients in the 120 μg Lambda treated group experienced a -1.5 log10 mean decline in HDV RNA, with 6 of 14 (42.9%) experiencing ≥2 log10 decline, 2 of 14 (14.3%) patients were HDV-RNA negative at end of treatment. The most common adverse events included mild to moderate flu-like symptoms and elevated transaminase levels.
"Lambda interferon demonstrated better tolerability in HDV-infected patients who were previously treated with Alfa interferon," said LIMT HDV Study Co-Lead Investigators, Ohad Etzion, MD, Director in the Department of Gastroenterology and Liver Diseases at Soroka University Medical Center and Saeed Hamid, MD, Chairman and Professor in Section of Gastroenterology, Department of Medicine, Aga Khan University. "Fewer episodes of cytopenia, flu-like symptoms, and psychiatric events in this study make Lambda interferon particularly attractive for further development as a monotherapy or in combination with other treatments for HDV."
"Lambda is the second proprietary product in the Eiger pipeline for development as a monotherapy or combination therapy in HDV," said David Apelian, COO and Executive Medical Officer at Eiger. "Lambda is now dosing in combination with Lonafarnib boosted with Ritonavir in HDV-infected patients in the Phase 2 LIFT study at the National Institutes of Health (NIH). We look forward to end of treatment data from this proprietary Lambda-Lonafarnib combination in 2019."
The company plans to share additional details from the Lambda LIMT study at the following AASLD 2018 events in San Francisco in November:
Liver Institute and Foundation for Education and Research (L.I.F.E.R.) Meeting: The Search for HBV/HDV Cure: Challenges for Industry; "Eiger Phase 3 HDV Lonafarnib 'D-LIVR' Study and Phase 2 HDV Lambda 'LIFT' Study," November 9
Eiger Phase 3 D-LIVR Study Investigator Reception, November 9
Hepatitis Delta International Network (HDIN) Meeting; "HDV Program Update: Lonafarnib Boosted with Ritonavir and Pegylated Interferon Lambda"; November 10
About Pegylated Interferon Lambda (Lambda)
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. Lambda targets type III IFN receptors which are distinct from the type I IFN receptors targeted by IFN alfa. These type III receptors are highly expressed on hepatocytes with limited expression on hematopoietic and central nervous system cells, which reduce off-target effects and improve tolerability of Lambda. Although Lambda does not use the IFN alfa receptor, signaling through either the IFN Lambda or IFN alfa receptor complexes results in the activation of the same Jak-STAT signal transduction cascade.
Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb in April 2016. Lambda has been administered in HBV / HCV clinical trials involving over 3,000 subjects. Lambda has not been approved for any indication. Eiger has received Orphan Designation and Fast Track Designation for Lambda in HDV.
About LIMT (Lambda Monotherapy) Study
LIMT HDV is a 1:1 randomized, open-label study of Lambda 120 or 180 μg subcutaneous injections administered weekly for 48 weeks in 33 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 are administered an anti-hepatitis B virus nucleos(t)ide analog throughout the study. LIMT HDV is an international study with sites in New Zealand, Israel and Pakistan.
About LIFT (Lambda Combo Therapy) Study
LIFT (Lambda InterFeron combo-Therapy) is an open-label, Phase 2 study evaluating Lambda + LNF + RTV in approximately 26 HDV-infected patients. Patients will be dosed for 24 weeks + undergo follow up for 24 weeks. Primary endpoint will be ≥ 2 log decline in HDV RNA at end of treatment. Secondary endpoints will include histology (> 2 point improvement in histological activity index and no progression in fibrosis) at end of treatment. LIFT is being conducted within the National Institutes of Health (NIH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).作者: StephenW 时间: 2018-10-18 09:13