Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced end of study post-treatment results of the Phase 2 LIMT HDV Study (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) reported as an oral late breaker presentation at The International Liver Congress™ 2019
PALO ALTO, Calif., April 11, 2019 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc, (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced end of study post-treatment results of the Phase 2 LIMT HDV Study (Lambda Interferon MonoTherapy in Hepatitis Delta Virus) 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 HDV, randomized to monotherapy Lambda 180 μg (N=14) or Lambda 120 μg (N=19), weekly subcutaneous injections for 48 weeks with 24 weeks of follow-up. Objectives of the Phase 2 LIMT HDV 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 most severe form of human viral hepatitis for which there is no approved therapy. “Lambda interferon was well tolerated in HDV-infected patients who were previously treated with Alfa interferon,” said Ohad Etzion, MD, Director in the Department of Gastroenterology and Liver Diseases at Soroka University Medical Center who co-led this study with Saeed Hamid, MD, Chairman and Professor in Section of Gastroenterology, Department of Medicine, Aga Khan University. “Low episodes of cytopenia, flu-like symptoms, and psychiatric events in the LIMT HDV study suggest Lambda interferon is particularly attractive for development as a monotherapy or in combination for 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 (NIH), and we look forward to end of treatment data later this year.” At Week 48, LIMT study patients treated with Lambda 180 μg experienced a mean decline in HDV-RNA of 2.3 log10, with 7 of 14 (50%) experiencing ≥ 2 log10 decline and 5 of 14 (36%) patients achieving HDV-RNA below the limit of quantification (BLQ), comparable to historical peginterferon alfa. At Week 72, a durable virologic response (DVR = HDV RNA below limit of quantitation) at 24 weeks post-treatment for Lambda 180 μg was achieved in 5 of 14 (36%), which compares favorably to historic rates for peginterferon alfa 180 μg (HIDIT-1 Study). Rates of alanine aminotransferase (ALT) normalization increased during post-treatment follow- up in LIMT HDV study patients, from 14% (2 of 14) at Week 48 to 36% (5 of 14) at Week 72. Common on-treatment adverse events included mild to moderate flu-like symptoms and elevated transaminase levels. Patients noted mild side effects while receiving Lambda therapy. Cases of jaundice and bilirubin elevations were observed in the Pakistani cohort. DILIsym® modeling of ALT and bilirubin dynamics indicate a transporter-based mechanism for the observed bilirubin elevations. 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. About Peginterferon Lambda (Lambda) Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb. The LIMT (Lambda Interferon Monotherapy) study in HDV-infected patients has completed dosing across international centers. Lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation and Fast Track Designation by the U.S. Food and Drug Administration (FDA) for Lambda in HDV. About LIMT (Lambda Monotherapy) Study About Lonafarnib Lonafarnib has been dosed in over 120 HDV-infected patients across international academic centers and is in Phase 3 with a single, international, pivotal trial (D-LIVR Study). Lonafarnib has been granted Orphan Drug designation by the U.S. FDA and European Medicines Agency (EMA), Fast Track and Breakthrough designation by U.S. FDA and PRIME designation by the EMA. Lonafarnib is not approved for any indication and is licensed from Merck Sharp & Dohme Corp. (known as MSD outside of the United States and Canada). About LIFT (Lambda and Lonafarnib Combo-therapy) Study About Hepatitis Delta Virus (HDV) Hepatitis delta is a disease with a significant impact on global health, which may affect up to 15-20 million people worldwide. The prevalence of HDV varies among different parts of the world. Globally, HDV infection is reported to be present in approximately 4.3% to 5.7% of chronic Hepatitis B carriers. The prevalence of HDV in patients infected with chronic HBV is even higher in certain regions, including certain parts of Mongolia, China, Russia, Central Asia, Pakistan, Turkey, Africa, Middle East and South America, with an HDV prevalence as high as 60% being reported in HBV-infected patients in Mongolia and Pakistan). About Eiger The company’s lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. Eiger is also preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com. Note Regarding Forward-Looking Statements Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the “Risk Factors” sections in the Annual Report on Form 10-K for the year ended December 31, 2018 and Eiger’s periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law. Investors: Ingrid Choong, PhD View original content to download multimedia:http://www.prnewswire.com/news-releases/eiger-announces-36-durable-virologic-response-at-24-weeks-post-treatment-with-peginterferon-lambda-in-phase-2-limt-hdv-study-at-the-international-liver-congress-2019-300830865.html SOURCE Eiger BioPharmaceuticals, Inc. | ||
Company Codes: NASDAQ-NMS:EIGR |