Eiger BioPharmaceuticals announced end of study post-treatment results of the Phase 2 LIMT HDV Study reported as an oral late breaker presentation at The International Liver Congress 2019 in Vienna, Austria. LIMT HDV enrolled a total of 33 patients with chronic Hepatitis Delta Virus. Objectives of the study were to demonstrate comparable activity and improved tolerability of peginterferon lambda – Lambda – versus historical peginterferon alfa in HDV-infected patients. Peginterferon Lambda is a first-in-class, type III interferon in development for the treatment of HDV. “The durable virologic response observed 24 weeks post-treatment with Lambda may be a meaningful endpoint for discussions with regulatory agencies,” said David Apelian, COO and Executive Medical Officer at Eiger. “Lambda is now being dosed in combination with Lonafarnib and Ritonavir in HDV-infected patients in the Phase 2 LIFT study at the National Institutes of Health, and we look forward to end of treatment data later this year.” At Week 72, a durable virologic response at 24 weeks post-treatment for Lambda 180 mug was achieved in 5 of 14, which compares favorably to historic rates for peginterferon alfa 180 mug. Common on-treatment adverse events included mild to moderate flu-like symptoms and elevated transaminase levels. Patients showed no symptoms of decompensation, no clinical abnormalities, no ascites, no worsening of synthetic function, and all patients responded favorably to dose reduction or dose discontinuation. Eiger licensed worldwide rights to Lambda from Bristol-Myers (BMY). Lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation and Fast Track Designation by the FDA for Lambda in HDV.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.