PALO
ALTO, Calif., Oct. 5, 2022
/PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR),
a commercial-stage biopharmaceutical company focused on the
development of innovative therapies for hepatitis delta virus (HDV)
and other serious diseases, today announced that, following
feedback from the U.S. Food and Drug Administration (FDA), the
company will not submit an emergency use authorization (EUA)
application of peginterferon lambda for the treatment of patients
with mild-to-moderate COVID-19.
Following Eiger's press release on September 6, 2022, the company submitted a
pre-EUA meeting request to FDA, as well as additional morbidity and
mortality outcomes data and analyses from the
investigator-sponsored TOGETHER study. This included further
statistical modeling and efficacy analyses of the study's primary
and secondary endpoints and long-term follow-up data that the
company believes continue to support the initial positive topline
outcomes reported in March. In response, FDA denied the request for
a pre-EUA meeting. Citing its concerns about the conduct of the
TOGETHER study, FDA concluded that any authorization request
based on these data is unlikely to meet the statutory criteria for
issuance of an EUA in the current context of the pandemic.
FDA suggested that, given peginterferon lambda's mechanism of
action and the ongoing need for improved COVID-19 therapeutics,
Eiger consider requesting an end-of-Phase 2 meeting to discuss a
company-sponsored pivotal trial that could support an eventual
Biologics License Application (BLA). Eiger is evaluating next steps
for this program, in the U.S., as well as ex-U.S. emergency use
authorization pathways and strategic options for continued
development of peginterferon lambda for COVID-19 and other
respiratory viral infections.
"While we are disappointed that FDA will not consider an EUA
application based on results generated from the TOGETHER
study, we continue to have strong conviction in the potential of
peginterferon lambda to confer a meaningful benefit for patients
with COVID-19 and other respiratory viral infections," said
David Cory, President and CEO,
Eiger. "COVID-19 related deaths remain alarmingly high around the
globe, including in the U.S. where, according to recent data from
the Centers for Disease Control and Prevention, approximately 400
people die every day from this disease."
Eiger is advancing a late-stage pipeline of multiple FDA
Breakthrough Therapy designated programs in Phase 3, including
lonafarnib and peginterferon lambda for hepatitis delta virus (HDV)
infection, and avexitide for congenital hyperinsulinism. The
company expects to report topline data from D-LIVR, Eiger's
landmark Phase 3 study of lonafarnib-based regimens for HDV, by
year end.
About TOGETHER
Study
TOGETHER is an independent multi-center,
investigator-sponsored, randomized, placebo-controlled adaptive
platform Phase 3 study evaluating therapeutics in newly diagnosed,
high-risk, non-hospitalized patients with mild-to-moderate
COVID-19. TOGETHER is the largest placebo-controlled study
in COVID-19 and has evaluated 11 different therapeutic agents for
non-hospitalized COVID-19 patients. The study was ongoing at the
time the peginterferon lambda arm was added. The evaluation of
peginterferon lambda versus placebo was the second largest study to
date of a COVID-19 therapeutic of > 1,900 patients. Eligibility
criteria required that all patients had laboratory-confirmed mild
or moderate COVID-19 and were randomized within seven days of
symptom onset. The study enrolled patients regardless of
vaccination status or variant strain of SARS-CoV-2. The primary
endpoint was a reduction in 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. A key secondary endpoint was
reduction in risk of hospitalizations or death in patients when
dosed within three days of symptom onset. The TOGETHER study
recruited from 12 sites in Brazil
and 5 sites in Canada.
For more information, please visit www.clinicaltrials.gov
(NCT04727424) and www.togethertrial.com.
About Peginterferon
Lambda
Peginterferon lambda is an investigational late-stage,
first-in-class, type III interferon (IFN) that stimulates immune
responses that are critical for the development of host protection
during 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 of HBV, HCV, HDV and COVID-19.
Peginterferon 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, and Fast Track and Breakthrough Therapy
Designation by FDA for peginterferon lambda in HDV.
Eiger licensed worldwide rights to peginterferon lambda from
Bristol-Myers Squibb.
About Eiger
Eiger is a commercial-stage biopharmaceutical company focused on
the development of innovative therapies for 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. 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.
Forward Looking
Statements
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,
prospective products, preclinical and clinical pipelines,
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, the timing of our
ongoing and planned clinical development; the sufficiency of our
cash, cash equivalents and investments to fund our operations; the
likelihood of obtaining alignment on a registration-enabling study
from the FDA for peginterferon lambda for COVID-19; the potential
actions of FDA and ex-U.S. regulatory authorities regarding the
continued development of peginterferon lambda for COVID-19 and
other respiratory viral infections; our capability to provide
sufficient quantities of any of our product candidates, including
peginterferon lambda, to meet anticipated full-scale commercial
demands; our ability to finance independently or through
collaborations the continued advancement of our development
pipeline, including the peginterferon lambda; expectations
regarding the timing and availability of topline 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 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 June 30, 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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SOURCE Eiger BioPharmaceuticals, Inc.