PALO ALTO, Calif., October 5, 2022 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), a commercial-stage biopharmaceutical company focused on developing innovative therapies for hepatitis delta virus (HDV) and other serious diseases, announced today Today that, following comments from the United States Food and Drug Administration (FDA), the company will not be submitting an Emergency Use Authorization (EUA) application for peginterferon lambda for the treatment of patients with COVID- 19 light to moderate.
After Eiger Press release on September 6, 2022the company has submitted an EUA pre-meeting request to the FDA, along with additional data and analyzes of the sponsored investigator’s morbidity and mortality outcomes TOGETHER study. This included additional statistical modeling and efficacy analyzes of the study’s primary and secondary endpoints and long-term follow-up data that the company says continues to support the first positive results reported in March. In response, the FDA denied the request for a pre-EUA meeting. Citing his concerns about the conduct of TOGETHER study, the FDA concluded that any request for authorization based on this data is unlikely to meet the statutory criteria for issuing an EUA in the current context of the pandemic.
The FDA has suggested that, given peginterferon lambda’s mechanism of action and the continued need for improved treatments for COVID-19, Eiger consider requesting an end-of-phase 2 meeting to discuss a sponsored pivotal trial. by the company that could support a potential Biologics License (BLA) application. Eiger is evaluating the next steps for this program, in the U.S., as well as ex-U.S. emergency use authorization pathways and strategic options for the continued development of peginterferon lambda for COVID-19 and others viral respiratory infections.
“While we are disappointed that the FDA is not considering an EUA application based on the results generated by the TOGETHER study, we continue to strongly believe in the potential of peginterferon lambda to confer significant benefit to patients with COVID-19 and other viral respiratory infections,” said David Cory, President and CEO, Eiger. “COVID-19-related deaths remain alarmingly high around the world, including in the United States where, according to recent data from the Centers for Disease Control and Prevention, approximately 400 people die from the disease every day.”
Eiger is advancing a late-stage pipeline of several FDA-designated programs for breakthrough Phase 3 therapy, including lonafarnib and peginterferon lambda for hepatitis delta virus (HDV) infection and avexitide for congenital hyperinsulinism. The company expects to release key data from D-LIVR, Eiger’s landmark Phase 3 study of lonafarnib-based treatment regimens for HDV, by the end of the year.
About TOGETHER Study
TOGETHER is an independent, multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating treatments in newly diagnosed, high-risk, non-hospitalized patients with mild to moderate COVID-19. TOGETHER is the largest placebo-controlled study of COVID-19 and evaluated 11 different therapeutic agents for non-hospitalized COVID-19 patients. The study was ongoing when the peginterferon lambda arm was added. The evaluation of peginterferon lambda versus placebo was the second largest study to date of a COVID-19 treatment of >1,900 patients. Eligibility criteria required that all patients have laboratory-confirmed mild or moderate COVID-19 and be randomized within seven days of symptom onset. The study recruited patients regardless of their vaccination status or SARS-CoV-2 variant strain. The primary endpoint was a reduced risk of clinical outcome comparing hospitalizations or emergency room visits greater than six hours after a single subcutaneous injection of peginterferon lambda versus placebo through day 28. Key secondary outcome was reduction in risk of hospitalization or death in patients when administered within three days of symptom onset. The TOGETHER study recruited from 12 sites in Brazil and 5 sites in Canada.
About peginterferon lambda
Peginterferon lambda is a first-in-class investigational late stage type III interferon (IFN) that stimulates immune responses essential for the development of host protection against viral infections and has been well tolerated in clinical studies.
Eiger is developing peginterferon lambda for the treatment of HDV infection. Peginterferon lambda has been administered to over 4,000 subjects in 28 clinical trials for HBV, HCV, HDV and COVID-19. Peginterferon lambda is an investigational agent and is not yet approved for any indication. Eiger has received orphan designation from the US Food and Drug Administration (FDA) and European Medicines Agency, and Fast Track and Breakthrough Therapy designation from the FDA for peginterferon lambda in HDV.
Eiger has obtained worldwide rights to peginterferon lambda from Bristol-Myers Squibb.
About the Eiger
Eiger is a commercial-stage biopharmaceutical company focused on developing innovative therapies for hepatitis delta virus (HDV) and other serious diseases. The Eiger HDV platform includes two first-in-class Phase 3 therapies that target critical host processes involved in viral replication. Eiger’s five rare disease programs have received FDA Breakthrough Therapy designation: lonafarnib and peginterferon lambda for HDV, Zokinvy for progeria, and avexitide for congenital hyperinsulinism and post-bariatric hypoglycemia.
For more 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 fact, including statements regarding our future financial condition, timing and clinical results, potential products, preclinical and clinical pipelines, regulatory goals, 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, prospects, analyzes or current expectations regarding, among other things, the timing of our ongoing and anticipated clinical development; the adequacy of our cash, cash equivalents and investments to fund our operations; the likelihood of obtaining alignment with a study allowing FDA registration for peginterferon lambda for COVID-19; potential actions by the FDA and former U.S. regulatory authorities regarding the continued development of peginterferon lambda for COVID-19 and other viral respiratory infections; our ability to supply sufficient quantities of any of our product candidates, including peginterferon lambda, to meet anticipated large-scale commercial demands; our ability to fund independently or through collaborations the continued advancement of our development pipeline, including peginterferon lambda; expectations regarding the timing and availability of key data from our Phase 3 D-LIVR study in HDV; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from Eiger’s forward-looking statements, including additional applicable risks and uncertainties described in the “Risk Factors” sections of the Quarterly Report on Form 10-Q for the quarter. ended June 30, 2022 and Eiger’s subsequent SEC filings. 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 new information, future events, changed circumstances or otherwise.
Wheelhouse Life Science Advisors
SVP, Corporate Affairs
SOURCEEiger BioPharmaceuticals, Inc.