- Prioritizing resources to advance avexitide in hyperinsulinemic
hypoglycemia indications
- Active discussions underway with potential partners to advance
late-stage virology programs
- Reduction in workforce executed to align with focus
on avexitide; extends cash runway to Q4 2024
- David Apelian, MD, PhD, MBA,
appointed CEO
- Live conference call and webcast at 8:30
am ET today
PALO
ALTO, Calif., June 29,
2023 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc.
(Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused
on the development of innovative therapies for rare diseases, today
announced that following an extensive portfolio prioritization
review, the Company will focus its development efforts on advancing
avexitide in hyperinsulinemic hypoglycemia indications. The Company
will continue to commercialize Zokinvy®
(lonafarnib) for the treatment of Hutchinson-Gilford progeria
syndrome and processing-deficient progeroid laminopathies. In
addition, Eiger is evaluating strategic partnering options for its
virology assets, lonafarnib and peginterferon lambda. A 25%
reduction in workforce, a reduction in out-of-pocket spending
related to its hepatitis delta (HDV) development program and its
existing term loan are expected to extend the Company's cash runway
into the fourth quarter of 2024. The Company also announced that it
has appointed David Apelian, MD,
PhD, MBA, who has served as interim Chief Executive Officer since
December 2022, as the Company's next
CEO.
"Today's environment necessitates prudent and strategic
evaluation of how to advance our promising and diverse pipeline in
order to develop potential breakthrough medicines for
patients and to drive stockholder value," said David Apelian, MD, PhD, MBA, CEO of Eiger.
"After a thorough examination of our programs, we are deploying our
resources toward recognizing the compelling potential of avexitide
in metabolic diseases. Our initial focus will be on post-bariatric
hypoglycemia, or PBH , where we see the highest revenue potential,
have demonstrated proof-of-concept in Phase 2 clinical trials, and
have FDA alignment on Phase 3 endpoints, sample size, and study
design. In the future, we also intend to develop avexitide for
congenital hyperinsulinism as a second indication. We plan to
provide further guidance next quarter on the progress of our
business development efforts for our virology assets, as well as
definitive plans for the PBH Phase 3 study initiation and key study
milestones."
Dr. Apelian continued, "For our other late-stage assets,
lonafarnib and peginterferon lambda, we believe the strength of our
data and alignment on a regulatory path with FDA make them
attractive to potential collaborators. We are actively engaged in
discussions with potential partners."
"David has embraced his role as CEO, which was a natural
transition given his proven tenure with Eiger as a board member and
previous Chief Operating Officer," said Thomas Dietz, PhD, non-executive Chairman of the
Board. "David's extensive clinical development and regulatory
experience gained from working at large pharmaceutical and
biotechnology companies, combined with his strategic vision and
previous leadership roles at Eiger, make him the right choice to
lead Eiger."
Current Pipeline
Avexitide for Post-Bariatric Hypoglycemia (PBH)
- A large orphan disease with a growing population; caused by
complications in bariatric surgery
- Prevalence of approximately 180,000 in the US and approximately
half that in the EU
- Avexitide is the only drug in development for PBH with
Breakthrough Therapy designation
- FDA alignment on pivotal Phase 3 study endpoints, sample size,
and design
Avexitide for Congenital Hyperinsulinism
- An ultra-rare, life-threatening, pediatric disorder of
persistent hypoglycemia that results in irreversible brain damage
in up to 50% of children
- Breakthrough Therapy designation from FDA
- Rare Pediatric Disease designation
Zokinvy® (lonafarnib) for Progeria and
Processing-Deficient Progeroid Laminopathies
- First quarter 2023 net product revenue of $4.1 million;
full year 2022 net product revenue of $12.7
million
Partnering Opportunities
Lonafarnib-Based Regimens for HDV
- First-in-class, oral prenylation inhibitor
- Phase 3 D-LIVR study complete; presented at
EASL 2023 in Vienna, Austria
-
- Week 48 primary endpoint achieved in both lonafarnib arms vs
PBO (1.9%) (N=407)
-
- Composite response rate in oral arm = 10.1% (p=0.0044)
- Composite response rate in combination arm = 19.2%
(p<0.0001)
- 24-week post-treatment data demonstrate that both lonafarnib
arms showed a statistically significant difference in composite
response rate compared to placebo (N=338)
-
- Composite response rate in oral arm = 14.2% (p<0.0001)
- Composite response rate in combination arm = 26.4%
(p<0.0001)
- HDV RNA BLQ response rate in oral arm = 6.1% (p=0.168)
- HDV RNA BLQ response rate in combination arm = 22.7%
(p<0.0001)
- Pre-NDA meeting with FDA supportive of potential path to
approval for oral and combination therapy
Peginterferon Lambda
- First-in-class, well-tolerated interferon
- Potential to be interferon of choice in antiviral combination
therapies
- Phase 3 LIMT-2 study of peginterferon lambda
monotherapy fully enrolled next month
- Potential for edevelopment in HDV, HBV, respiratory diseases
such as COVID and influenza, as well as other virology
indications.
Conference Call Details
The live and replayed webcast
of the call will be available through the company's website at
www.eigerbio.com. To participate in the live call by phone, dial
(866) 524-3160 (U.S.) or (412) 317-6760 (International). The
webcast will be archived and available for replay for at least 90
days after the event.
About Dr. David
Apelian
Dr. Apelian has 23 years of clinical
development and regulatory experience with large pharmaceutical and
biotechnology companies, including nearly six years in senior
management, advisory and Board roles at Eiger. He has served as the
Company's interim CEO since December
2022. He had previously served as the Company's Chief
Operating Officer and Executive Medical Officer starting in 2018,
responsible for heading the company's R&D, Medical and
Regulatory Affairs operations. Following his departure from that
position in 2019, he has served as a Senior Clinical Advisor and
board member at Eiger. Dr. Apelian was also the founding CEO of
BlueSphere Bio. In addition, Dr. Apelian was Executive Vice
President and Chief Medical Officer of Achillion Pharmaceuticals,
Inc. where he was responsible for creating portfolio strategy and
managing the company's clinical development programs. Earlier in
his career, he held senior management positions at GlobeImmune,
Bristol-Myers Squibb, and Schering Plough. Dr. Apelian has
extensive experience in chronic HCV, chronic HBV, immune oncology
and rare diseases.
About Post-Bariatric
Hypoglycemia
Post-bariatric hypoglycemia (PBH) and other
forms of hyperinsulinemic hypoglycemia (HH) after gastrointestinal
surgeries are characterized by exaggerated secretion of
glucagon-like peptide-1 (GLP-1) after meals, dysregulated secretion
of insulin, and a rapid drop in blood sugar. Hypoglycemia
typically occurs one to three hours after meals and is often
accompanied by symptoms of brain glucose starvation
(neuroglycopenia), such as blurred vision, confusion, speech
difficulty and incoordination.
Severe hypoglycemia events can result in serious outcomes such
as loss of consciousness, falls, seizures, and motor vehicle
accidents, putting patients at risk for death and disability.
Recurrent hypoglycemia events can have serious implications on
quality of life, including heightened fear of hypoglycemia and
reduced functionality, such as ability to work, drive and
independently perform activities of daily living.
PBH is an orphan disease caused by complications in bariatric
surgery with a prevalence of approximately 180,000 in the US and
approximately half that in the EU.
About Avexitide
Avexitide is an investigational,
first-in-class glucagon-like peptide-1 receptor (GLP-1r) antagonist
in development for the treatment of post-bariatric hypoglycemia
(PBH) and congenital hyperinsulinism (HI). Avexitide has been
granted Breakthrough Therapy designation for both PBH and HI.
Because avexitide binds to the GLP-1r on pancreatic beta cells
and prevents GLP-1r signaling, it works upstream of beta cell
insulin secretion to reduce dysregulated insulin secretion and
the occurrence of hypoglycemia. By addressing underlying disease
mechanisms, avexitide may offer a targeted approach to
treating hypoglycemia in patients with hyperinsulinemic
hypoglycemia, including PBH and HI. Eiger has developed a novel
formulation of avexitide for subcutaneous injection.
About Eiger
Eiger is a commercial-stage biopharmaceutical company focused on
the development of innovative therapies for are 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; our ability to identify,
pursue and enter into partnering opportunities for our virology
assets; the sufficiency of our cash, cash equivalents and
investments to fund our operations into fourth quarter of 2024,
including the scope and impact of any savings from our workforce
reduction and cash conservation efforts; the revenue potential of
avexitide in post-bariatric hypoglycemia and congenital
hyperinsulinism; our ability to finance, independently or through
collaborations, 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" section in
Eiger's Quarterly Report on Form 10-Q for the quarter ended
March 31, 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.