PALO
ALTO, Calif., Sept. 6,
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 provided an update on
the status of its planned request for emergency use authorization
(EUA) of peginterferon lambda for the treatment of patients with
mild-to-moderate COVID-19 based on its most recent communications
with the U.S. Food and Drug Administration (FDA).
Following a cooperative and extensive pre-EUA information
exchange with FDA regarding the Phase 3 TOGETHER study of
peginterferon lambda for COVID-19, the agency has indicated that it
is not yet able to determine whether the criteria for the
submission of an application and issuance of an EUA are likely to
be met. FDA has indicated that it will consider any new information
and data from the TOGETHER study to support an EUA as
well as the company's plans for the further development of
peginterferon lambda for COVID-19. Eiger remains in active dialogue
with FDA and will provide additional information to the agency that
the company believes could be supportive of an EUA.
"We appreciate the active dialogue with FDA and remain committed
to continued engagement with the agency to obtain the necessary
alignment to submit our EUA application for peginterferon lambda,"
said David Cory, President and CEO,
Eiger. "Given its unique mechanism of action and the ongoing need
for effective COVID-19 therapeutics, making peginterferon lambda
available for patients remains a priority for Eiger."
The company has recently generated new data and analyses from
the TOGETHER study that it plans to discuss with FDA,
including further statistical modeling and efficacy analyses of the
study's primary and secondary endpoints in patients treated within
three days of symptom onset. The endpoint of hospitalization due to
COVID-19 and all-cause mortality for patients treated within three
days of symptom onset is consistent with the endpoint used to
authorize other therapeutics for emergency use and is summarized
below:
|
Patients Treated Within 3 Days of Symptom
Onset
|
Population
|
Hospitalization due to
COVID-19 / All-Cause
Mortality
|
Hospitalization / Mortality
due to COVID-19
|
Hospitalization due to
COVID-19
|
Intent to Treat
(ITT)
N=1,1541
|
RRR2
0.58
Pr3
0.991
p=0.026
|
RRR 0.62
Pr 0.996
p=0.014
|
RRR 0.62
Pr 0.996
p=0.014
|
1 n=567
(peginterferon lambda), n=587 (placebo)
|
2 Relative
Risk Reduction
|
3 Probability of superiority;
threshold for superiority = 0.976
|
The original efficacy analysis of the data generated from the
TOGETHER study was based on dosing peginterferon lambda
within seven days of symptom onset.
In addition, Eiger plans to provide new additional analyses of
long-term follow-up data, including rates of rebound and incidence
of long COVID, as well as an indirect comparative analysis of
mortality and hospitalizations in vaccinated patients when treated
with peginterferon lambda compared to other therapeutics authorized
for emergency use.
The company is working with the TOGETHER investigators on
the publication of a manuscript in a peer reviewed journal.
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.
Peginterferon lambda is to be administered as a single
subcutaneous injection so that it can be prescribed and
administered at the first sign of infection or at first awareness
of an exposure, potentially helping patients avoid severe illness
that can lead to hospitalization and death.
IFN lambdas are critical for maintaining a balanced antiviral
response in the respiratory tract. They are induced at lower viral
burden before type I IFNs to limit the initial infection by
inducing viral resistance to cells and helping them deal with the
virus load. IFN lambda lacks the strong pro-inflammatory effects of
type I IFNs and are tissue-protective and anti-inflammatory.
Administration of IFN lambda has been shown to suppress viral
replication while stopping 'cytokine storm' from developing.
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 TOGETHER Study
TOGETHER is a
multi-center, investigator-sponsored, randomized,
placebo-controlled adaptive platform Phase 3 study evaluating
therapeutics in newly diagnosed, high-risk, non-hospitalized
patients with 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. This
evaluation of peginterferon lambda versus placebo was the second
largest study to date of a COVID-19 therapeutic. Eligibility
criteria required that all patients had laboratory-confirmed
mild-to-moderate COVID-19, and were randomized within seven days of
symptom onset. High-risk criteria were defined by patients having
at least one of the following, including but not limited to: >
age 50, diabetes, hypertension, CV disease, lung disease, kidney
disease, obesity, etc. The study enrolled patients regardless of
vaccination status or variant strain of SARS-CoV-2. The primary
endpoint was a clinical outcome comparing hospitalizations or
emergency room visits greater than six hours after a single
subcutaneous injection of peginterferon lambda versus placebo. The
Data Safety Monitoring Board provided independent oversight for the
trial and had previously discontinued other therapeutics due to
observed futility. 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 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 planned request for emergency use
authorization of peginterferon lambda for the treatment of
COVID-19, further development of peginterferon lambda, future
interactions with FDA, 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 an emergency use authorization from FDA
for peginterferon lambda for COVID-19; 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 the continued advancement of our
development pipeline; 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.