Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that its abstract describing the global
in-progress Phase 2 study of CAL02, a first-in-class,
broad-spectrum, anti-virulence agent under development as an
adjunct to antibiotic therapy for the treatment of severe
community-acquired bacterial pneumonia (“SCABP”), has been selected
for a poster presentation at the conference co-sponsored by the
American Society for Microbiology (“ASM”) and the European Society
for Clinical Microbiology and Infectious Diseases (“ESCMID”). This
prestigious, multidisciplinary meeting is focused on the
challenges, opportunities, and current requirements for
antimicrobial drug development to address antimicrobial resistance.
The conference is scheduled to take place September 19-22, 2023, in
Boston, Massachusetts.
“We are pleased to have the opportunity to present additional
details of the CAL02 study in progress to our esteemed colleagues,”
stated Valentin Curt, MD, Senior Vice President, Clinical Drug
Development and Interim Chief Medical Officer at Eagle
Pharmaceuticals. “Inclusion at this scientific congress supports
the significance of the potential clinical value of CAL02 to
address a large, unmet medical need. Antimicrobial resistance is
one of the world’s most urgent public health challenges, and SCABP
is a prevalent infectious disease associated with high morbidity
and mortality, despite the availability of vaccines, effective
antibiotic regimens, and state-of-the-art critical care therapy.
CAL02 has the potential to mitigate organ damage, pro-inflammatory
responses, and to facilitate killing the underlying pathogen,
without contributing to antibiotic resistance We look forward to
sharing details of the study, its progress, as well as of CAL02’s
potential to redefine the treatment of SCABP without contributing
to antibiotic resistance,” concluded Curt.
Details of the poster presentation are as follows:
Abstract |
|
Title: |
A Randomized, Double-Blind, Placebo Controlled Multicenter Study to
Evaluate the Efficacy and Safety of CAL02 Administered
Intravenously in Addition to Standard of Care (SOC) in Subjects
with Severe Community-Acquired Bacterial Pneumonia (SCABP) |
|
|
Date: |
September 20, 2023 |
Time: |
3:35pm ET |
Location: |
Poster Presentations Session I |
In June 2023, the U.S. Food and Drug Administration (“FDA”)
granted Qualified Infectious Disease Product (“QIDP”) Designation
and Fast Track Designation for CAL02, entitling Eagle to an
additional five years of marketing exclusivity upon approval. Eagle
believes that CAL02 could also be eligible for breakthrough therapy
and new chemical entity (“NCE”) designations, which would result in
five years of marketing exclusivity upon approval or three years
without NCE designation, resulting in a total potential of eight or
ten years of exclusivity.
In July 2023, the first patients were randomized in a
multi-center adaptive, randomized, double-blind, placebo-controlled
Phase 2 study designed to assess the efficacy and safety of CAL02
administered intravenously in addition to standard of care in
patients with SCABP. The study plans to enroll approximately 276
patients with SCABP worldwide. Additional details are available on
ClinicalTrials.gov (Identifier: NCT05776004). Depending upon
recruitment rates, Eagle anticipates having its 50% interim report
around the first half of 2024.
Eagle is also further developing the patent estate to protect
the intellectual property resulting from the development of CAL02.
CAL02 is currently protected by issued U.S. Patent No.10,744,089,
which extends until September 2035, and may be eligible for Patent
Term Extension for up to five years until 2040.
About CAL02CAL02 is an investigational,
innovative, first-in-class anti-infective agent that acts as a
competitive decoy, or lure, for bacterial virulence factors, which
contribute to infection-related complications, sepsis, septic
shock, and death. CAL02 consists of proprietary liposomes
engineered to capture the virulence factors produced by a broad
range of Gram-positive and Gram-negative bacteria causing severe
infectious diseases, including severe pneumonia. CAL02 is poised to
play a key role in the fight against anti-microbial resistance. Its
action is complementary to that of antibiotics, and it does not
appear to exert any selective pressure, which can contribute to
antibiotic resistance. Because of these characteristics, CAL02
could be administered empirically in combination with standard of
care as soon as patients show signs of severe pneumonia. Clinical
results to date underscore the potential of CAL02 to transform the
standard of care and to dramatically reduce the time and the cost
of care for millions of critically ill SCABP patients. Eagle has a
worldwide exclusive license on CAL02 acquired from Combioxin
SA.
About Virulence FactorsVirulence is a
bacteria’s ability to infect a host and produce disease. Virulence
factors are produced by a variety of pathogens and assist in
potentiating infection, evading and suppressing the immune system,
and damaging host cells, including immune cells, and organs.
Blocking the activities of virulence factors is a new approach that
has emerged over the last decade. Anti-virulence drugs, a new class
of drugs, target virulence factors of pathogens, effectively
disarming infectious pathogens.About Eagle Pharmaceuticals,
Inc. Eagle is a fully integrated pharmaceutical company
with research and development, clinical, manufacturing and
commercial expertise. Eagle is committed to developing innovative
medicines that result in meaningful improvements in patients’
lives. Eagle’s commercialized products include PEMFEXY®, RYANODEX®,
BENDEKA®, BELRAPZO®, TREAKISYM® (Japan), and BYFAVO® and BARHEMSYS®
through its wholly owned subsidiary Acacia Pharma Inc. Eagle’s
oncology and CNS/metabolic critical care pipeline includes product
candidates with the potential to address underserved therapeutic
areas across multiple disease states, and the company is focused on
developing medicines with the potential to become part of the
personalized medicine paradigm in cancer care. Additional
information is available on Eagle’s website at www.eagleus.com.
Forward-Looking StatementsThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, as amended, and
other securities law. Forward-looking statements are statements
that are not historical facts. Words and phrases such as
“anticipated,” “forward,” “will,” “would,” “could,” “may,”
“remain,” “potential,” “prepare,” “expected,” “believe,” “plan,”
“near future,” “belief,” “guidance,” and similar expressions are
intended to identify forward-looking statements. These statements
include, but are not limited to, statements with respect to: the
Company’s ability to develop innovative medicines that address
unmet medical needs; the Company’s expectations for the design and
timing of the planned Phase 2 study, including with respect to
enrollment and site selection and the timing thereof; statements
regarding the potential of CAL02 to be a medical breakthrough and
offer unique or meaningful therapeutic benefits to seriously ill
patients, potentially improving the treatment regimen for patients
with severe community-acquired pneumonia, shortening the duration
of illness and improving patient outcomes; statements regarding
potential regulatory exclusivity, CAL02’s potential eligibility for
fast track and breakthrough therapy designations and the potential
for a CAL02 new drug application for the treatment of SCABP to
qualify for priority review; statements regarding the Company’s
expectation to strengthen the patent portfolio for CAL02; and the
potential of the Company’s pipeline and product candidates to
address underserved therapeutic areas across multiple disease
states. All of such statements are subject to certain risks and
uncertainties, many of which are difficult to predict and generally
beyond the Company’s control, that could cause actual results to
differ materially from those expressed in, or implied or projected
by, the forward-looking information and statements. Such risks and
uncertainties include, but are not limited to: the impacts of the
post- COVID-19 environment and geopolitical factors such as the
conflict in Ukraine; delay in or failure to obtain regulatory
approval of the Company's or its partners’ product candidates and
successful compliance with FDA, European Medicines Agency and other
governmental regulations applicable to product approvals; changes
in the regulatory environment; the uncertainties and timing of the
regulatory approval process; whether the Company can successfully
market and commercialize its product candidates; the success of the
Company's relationships with its partners; the outcome of
litigation involving any of its products or that may have an impact
on any of its products; the strength and enforceability of the
Company’s intellectual property rights or the rights of third
parties; competition from other pharmaceutical and biotechnology
companies and the potential for competition from generic entrants
into the market; unexpected safety or efficacy data observed during
clinical trials; clinical trial site activation or enrollment rates
that are lower than expected; the risks inherent in drug
development and in conducting clinical trials; unanticipated
factors in addition to the foregoing that may impact the Company’s
financial and business projections and guidance and may cause the
Company’s actual results and outcomes to materially differ from its
projections and guidance; and those risks and uncertainties
identified in the “Risk Factors” sections of the Company's Annual
Report on Form 10-K for the year ended December 31, 2022, filed
with the Securities and Exchange Commission (the “SEC”) on March
23, 2023, the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2023, filed with the SEC on May 9, 2023,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
June 30, 2023, filed with the SEC on August 8, 2023 and its other
subsequent filings with the SEC. Readers are cautioned not to place
undue reliance on these forward-looking statements. All
forward-looking statements contained in this press release speak
only as of the date on which they were made. Except to the extent
required by law, the Company undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made.
Investor Relations for Eagle Pharmaceuticals,
Inc.: Lisa M. WilsonIn-Site Communications, Inc. T:
212-452-2793 E: lwilson@insitecony.com
Public Relations for Eagle Pharmaceuticals,
Inc.:Faith Pomeroy-WardT: 817-807-8044E:
faith@eagleus.com
A photo accompanying this announcement is available
at:https://www.globenewswire.com/NewsRoom/AttachmentNg/30193350-3287-4ef3-bc42-cdd688fef55c
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