PALO ALTO, Calif., Sept. 12, 2023 /PRNewswire/ -- Eiger
BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage
biopharmaceutical company focused on the development of innovative
therapies for rare metabolic diseases, today announced its decision
to discontinue the Phase 3 LIMT-2 study of peginterferon
lambda in patients with chronic hepatitis delta (CHD). The decision
is based on the recommendation of the Data Safety Monitoring Board
(DSMB) for the study following its quarterly safety review. In a
communication dated September 7,
2023, the DSMB recommended the discontinuation of the
LIMT-2 study due to observations of four patients with
hepatobiliary events that resulted in liver decompensation.
"The study discontinuation is disappointing, especially for
patients with chronic hepatitis delta who have limited treatment
options," said David Apelian, MD, PhD, MBA, CEO of Eiger. "We
will work closely with FDA and our investigators to conduct an
orderly termination of the LIMT-2 study in the interest of
patient safety."
The Phase 3 LIMT-2 study is an open-label, parallel-arm
clinical trial that randomized patients with well-compensated CHD
infection to one of two treatment groups: peginterferon lambda 180
mcg QW for 48 weeks with 24 weeks follow-up (Arm 1, n=105), or no
treatment for 12 weeks followed by peginterferon lambda treatment
for 48 weeks with 24 weeks of follow-up (Arm 2, n=53). In July, the
trial completed enrollment of 158 patients in 12 countries across
48 investigator sites.
Dr. Apelian added, "As we look toward the future for Eiger, we
will continue to execute on our strategic pivot, announced on
June 29 of this year, and seek the
financial resources required to advance the Company's development
activities on avexitide in hyperinsulinemic hypoglycemia
indications. We continue to evaluate strategic partnering options
for our virology assets. Eiger is no longer in active discussions
with potential partners for a worldwide license for peginterferon
lambda."
About Eiger
Eiger is a commercial-stage biopharmaceutical company focused on
the development of innovative therapies for rare metabolic
diseases. Eiger's lead product candidate, avexitide, is a well
characterized, first-in-class GLP-1 antagonist for the treatment of
post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism
(HI). Avexitide is the only drug in development for PBH with
Breakthrough Therapy designation from the FDA.
For additional information about Eiger and its clinical
programs, please visit www.eigerbio.com.
Note Regarding 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, including our development
activities for avexitide in hyperinsulinemic hypoglycemia
indications; our ability to secure financial resources required to
advance avexitide in hyperinsulinemic hypoglycemia indications; our
ability to identify, pursue and enter into partnering opportunities
for our virology assets; 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"
section in Eiger's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2023 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.
Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com
Media:
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com
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SOURCE Eiger BioPharmaceuticals, Inc.