Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the
“Company”) today announced that the first patient has been
randomized in its 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 severe community-acquired
bacterial pneumonia (SCABP). The Phase 2 study plans to enroll
approximately 276 patients with SCABP at more than 100 sites in
over 20 countries worldwide. Additional details are available on
ClinicalTrials.gov (Identifier: NCT05776004). The Company expects
to have approximately 50 sites up and running by the end of
September, with 100 sites up by year-end in readiness for the
global pneumonia season. In addition, depending upon recruitment
rates, Eagle anticipates having its first 50% interim report around
the first quarter of 2024.
SCABP is a worldwide 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 is a novel first-in-class
broad-spectrum anti-virulence agent being developed as an add-on to
standard of care treatment of SCABP. CAL02 consists of proprietary,
engineered liposomes that capture and neutralize bacterial toxins
known to dysregulate inflammation, cause organ damage, and impede
immune defense. A Phase 1 safety and tolerability trial in SCABP
patients was successfully completed, in which encouraging trends
for efficacy were observed. The results were published in The
Lancet Infectious Diseases, where accompanying comments
characterized CAL02 as “One step closer to precision medicine for
infectious diseases,” describing the study as a “medical
breakthrough.”
“Owing to the complexity of severe bacterial pneumonia, patients
are in need of more effective treatment options. This presents an
opportunity to develop a novel adjunctive therapy for SCABP
patients. While antibiotics address the bacterial infection,
patient recovery is imperiled by the effects of bacterial virulence
factors, which can cause immunological and inflammatory responses
that may lead to organ failure, sepsis and death,” stated Scott
Tarriff, President and Chief Executive Officer of Eagle
Pharmaceuticals. “Until now, drugs targeting virulence factors have
been limited by the need to know which bug specifically caused the
infection. Because CAL02 relies on mechanics common across a vast
majority of virulence factors produced by the most common
pathogens, we believe it could have broad utility. We believe CAL02
has the potential to elevate the standard of care for severe
bacterial pneumonia, and we are delighted to be moving this
clinical program forward. While we are currently focused on the
U.S., we have a worldwide license, which could result in additional
commercial markets for CAL02 in the future.”
“Mortality rates for intensive care unit pneumonia patients
remain as high as 40%2 worldwide due to complications that can
occur even when tissues are pathogen-free and the lungs are
clearing. Virulence factors are increasingly considered to be a
common denominator in severe, complicated, and resistant bacterial
infections,” stated Dr. Valentin Curt, Senior Vice President,
Clinical Drug Development and Interim Chief Medical Officer for
Eagle Pharmaceuticals.
“CAL02, a first-in-class, broad-spectrum, anti-virulence agent
under development for the treatment of SCABP, neutralizes the most
common virulence factors. It has the potential to mitigate organ
damage, pro-inflammatory responses, and to facilitate killing the
underlying pathogen, without contributing to antibiotic resistance.
We are excited by the opportunity to build on the promising
clinical results of the Phase I first-in-human study, with the goal
of advancing SCABP patient care and providing critical care and
infectious disease physicians with urgently needed additional
treatment options.”
Eagle believes that CAL02 could also be eligible for
breakthrough therapy and new chemical entity (NCE)
designations.
Eagle is also further developing the patent estate to protect
the intellectual property resulting from the development of this
novel, first-in-class therapy. 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. CAL02 is also protected by granted counterparts
in important markets globally, e.g., Europe and Japan. In addition,
CAL02 and its uses are the subject of pending patent families as
reflected in published applications WO2017216282, WO2018158375,
WO2019201937, WO2019202101, US2023/0028179, US2021/0275452,
US2021/0030677, US2021/0259967, and other families under
development. These families would provide patent term until
approximately 2037 or later.
In August 2021, Eagle entered into a worldwide licensing
agreement with Combioxin SA for the commercial rights to CAL02.
About the Phase 2 CAL02 Study
A Phase 2 adaptive, randomized, double-blind, placebo-controlled
study is underway, designed to assess the efficacy and safety of
CAL02 administered intravenously in addition to standard of care in
patients with severe community-acquired bacterial pneumonia
(SCABP). The study plans to enroll approximately 276 patients with
SCABP worldwide. Additional details are available on
ClinicalTrials.gov (Identifier: NCT05776004).
About CAL02 CAL02 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 Factors Virulence 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. Additional information is available on
Eagle’s website at www.eagleus.com.
Forward-Looking Statements This 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 regarding 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
ongoing COVID-19 pandemic, including interruptions or other adverse
effects on clinical trials and delays in regulatory review or
further disruption or delay of any pending or future litigation;
delay in or failure to obtain regulatory approval of the Company's
product candidates and successful compliance with FDA, European
Medicines Agency and other governmental regulations applicable to
product approvals; 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; the risks inherent in drug
development and in conducting clinical trials; 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 Reports on Form
10-Q for the quarters ended March 31, 2023, filed with the SEC on
May 9, 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
1
https://www.thoracic.org/patients/patient-resources/resources/top-pneumonia-facts.pdf
2 Laterre PF, Colin G, Dequin PF, Dugernier T, Boulain T,
Azeredo da Silveira S, Lajaunias F, Perez A, François B. CAL02, a
novel antitoxin liposomal agent, in severe pneumococcal pneumonia:
a first-in-human, double-blind, placebo-controlled, randomised
trial. Lancet Infect Dis. 2019 Jun;19(6):620-630. doi:
10.1016/S1473-3099(18)30805-3. Epub 2019 May 2. PMID: 31056427.
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