Eiger Announces Peginterferon Lambda - Lonafarnib Combination Interim Results in Hepatitis Delta Virus (HDV) Infection from Phase 2 LIFT Study During Late-Breaker Oral Presentation at AASLD 2019
Eiger Announces Peginterferon Lambda - Lonafarnib Combination Interim Results in Hepatitis Delta Virus (HDV) Infection from Phase 2 LIFT Study During Late-Breaker Oral Presentation at AASLD 2019 - 53% of Patients Achieve Undetectable or BLOQ HDV RNA at Week 24 |
[12-November-2019] |
PALO ALTO, Calif., Nov. 12, 2019 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted, first-in-class therapies for serious rare and ultra-rare diseases, today announced a late-breaker oral presentation at AASLD 2019 of interim end of treatment results of the Phase 2 LIFT Lambda combination study in HDV-infected patients. The LIFT study is being conducted within the National Institutes of Health (NIH) at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Lambda is a first-in-class type III interferon in clinical development for HDV, the most severe form of human viral hepatitis. There is no approved treatment for HDV.
"We have previously presented promising results in multiple studies at NIDDK that Lonafarnib reduces HDV RNA viral load in patients infected with HDV," said Christopher Koh, MD, Principal Investigator at the NIDDK. "Lambda and Lonafarnib combination interim end of treatment results from the ongoing LIFT study are very encouraging and represent a potential foundational combination treatment for HDV. We look forward to presenting additional results from the LIFT study in the future." LIFT is a Phase 2a open-label study of 26 adult patients with chronic HDV treated with Lambda 180 mcg once weekly in combination with Lonafarnib 50 mg twice daily boosted with ritonavir 100 mg twice daily for 24 weeks. Primary efficacy endpoint is > 2 log HDV RNA decline at end of treatment. Median baseline evaluations included: ALT (64 IU/mL), AST (47 IU/mL), Ishak Fibrosis (3), modified HAI inflammation (9), HBV DNA (< 21 IU/mL) and log HDV RNA (4.74 IU/mL). At the time of analysis, 19 of 26 patients had reached Week 24. Median HDV RNA decline was 3.4 log IU/mL (IQR: 2.9-4.5, p<0.0001) with 7 patients (37%) achieving undetectable HDV RNA and 3 patients (16%) BLOQ. 18 of 19 patients (95%) achieved> 2 log decline during 24 weeks of therapy. Subjects who achieved undetectable HDV RNA levels during therapy trended towards significance of having lower baseline HDV RNA levels compared to those who achieved > 2 log decline but not HDV RNA undetectable or BLOQ, suggesting that baseline viral load may be predictive of virologic response. Adverse events were mostly mild to moderate and included GI related side effects, weight loss, hyperbilirubinemia, and anemia. Per-protocol dose-reductions occurred in 3 patients and discontinued in 4 patients, and were mostly due to known side effects related to peginterferon lambda. About Peginterferon Lambda (Lambda) Eiger licensed worldwide rights to Lambda from Bristol-Myers Squibb. Eiger is developing Lambda as a monotherapy and in combination with Lonafarnib boosted with ritonavir. Lambda is an investigational agent and not yet approved for any indication. Eiger has received Orphan Designation by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and Fast Track and Breakthrough Therapy Designation by FDA for Lambda in HDV. 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 Therapy Designation by the 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 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. 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. The company is rapidly advancing peginterferon lambda, a first-in-class interferon, toward registration for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to submit an NDA by year-end 2019, followed by an MAA submission in the first quarter of 2020. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and Eiger's subsequent filings 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-peginterferon-lambda---lonafarnib-combination-interim-results-in-hepatitis-delta-virus-hdv-infection-from-phase-2-lift-study-during-late-breaker-oral-presentation-at-aasld-2019-300956245.html SOURCE Eiger BioPharmaceuticals, Inc. | ||
Company Codes: NASDAQ-NMS:EIGR |
© 2019 PR Newswire. All Rights Reserved.