Eiger BioPharmaceuticals Announces Results from Multiple Presentations at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022
Eiger BioPharmaceuticals (Nasdaq: EIGR) presented significant data at the EASL International Liver Congress 2022 on their hepatitis delta virus (HDV) therapies. The Phase 3 D-LIVR study showcases the largest cohort of HDV patients, revealing alarming cirrhosis rates, with over 40% of affected patients being ≤ 45 years old. The studies on peginterferon lambda demonstrate its superior antiviral activity. Eiger also holds Breakthrough Therapy designations for several of its programs. Topline results from D-LIVR are anticipated by year-end.
- Presentation of significant data at EASL 2022 reinforces EIGR's leadership in HDV therapies.
- Phase 3 D-LIVR study represents the largest cohort of HDV patients, enhancing data credibility.
- Peginterferon lambda shows improved antiviral efficacy compared to historical therapies.
- Eiger's programs receive FDA Breakthrough Therapy designations, indicating high potential.
- High rates of cirrhosis reported in younger HDV patients highlight potential disease severity.
- Uncertainty remains until topline results from D-LIVR are released, creating investor risk.
PALO ALTO, Calif., June 27, 2022 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases, today announced data presented at the European Association for the Study of the Liver (EASL) International Liver Congress™ 2022 that took place June 22-26 in London, United Kingdom.
"We are pleased that EASL recognized our HDV platform with multiple presentations this year highlighting both the lonafarnib and peginterferon lambda programs," said David Cory, President and CEO, Eiger. "Our Phase 3 D-LIVR study will produce the single largest cohort of patient data from a well-controlled global study of HDV. We look forward to continued collaboration with investigators and key opinion leaders to mine this deep data set, providing additional insights, with a goal of improving outcomes for the global HDV patient population. In parallel, we are preparing for topline results from the landmark D-LIVR study by end of year."
Abstract #3442: Clinical Features Predictive of Cirrhosis in a Large Cohort of Patients with Chronic Hepatitis Delta Infection - Insights from the D-LIVR Trial; Etzion, O., Asselah, T., Lampertico, P. et al.
Conclusions: In the on-going Phase 3 D-LIVR study, the largest cohort to date of patients with chronic HDV, alarmingly high rates of cirrhosis were seen among patients with compensated liver disease at a relatively young mean age. Over
Abstract #2072: Mathematical Modeling of HDV RNA Kinetics Suggests High Peginterferon Lambda Efficacies in Blocking Viral Production and Infection: Insights from the LIMT-1 Study; Cardozo-Ojeda, E.F., Etzion, O. et al.
Conclusions: Previously reported end of study data of Phase 2 LIMT-1 trial of peginterferon lambda (Lambda) monotherapy showed that Lambda therapy had better antiviral activity and tolerability compared to historical data for peginterferon alfa and identified four main HDV RNA kinetic patterns under Lambda therapy. This study provides, for the first time, a dynamic description of HDV response under Lambda monotherapy. Lambda blocks viral production with high efficacy. HDV kinetics depend on Lambda efficacy, the baseline fraction of noninfected hepatocytes and their proliferation rates.
Abstract #1904: Lonafarnib Combination with Peginterferon Lambda Diminished Triphasic HDV Kinetic Pattern Seen Under Lambda Monotherapy: the LIFT-1 HDV Study; Duehren, S., Dahari, H., Heller, T. et al.
Conclusions: End of study data of Phase 2 LIFT-1 study of peginterferon lambda combined with lonafarnib was previously reported (AASLD 2020). The goal of the current study was to characterize HDV RNA, HBV DNA, HBsAg and ALT kinetics during and after combination therapy. Combination therapy was associated with better treatment success (≥ 2 log decline HDV RNA) compared to Lambda monotherapy. No null responders with Lambda + Lonafarnib. Reduction of the triphasic kinetic pattern suggests that the addition of Lonafarnib may decrease production/release of HDV RNA. Kinetic patterns observed in Lambda + Lonafarnib and Lambda monotherapy are associated with treatment response.
Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication. Eiger is also developing peginterferon lambda as a therapeutic for COVID-19 and reported positive results from TOGETHER, a Phase 3 investigator-initiated study.
All five Eiger rare disease programs have been granted FDA Breakthrough Therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for both congenital hyperinsulinism and post-bariatric hypoglycemia.
For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, regulatory objectives, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our anticipated significant milestones in 2022; the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; expectations regarding the timing and availability of topline data from our Phase 3 D-LIVR study in HDV; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2022 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.
Contacts
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Media:
Sarah Mathieson
SVP, Corporate Affairs
smathieson@eigerbio.com
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