- New emerging, favorable microbiome data to be presented from
previously completed Ph1 healthy volunteers and Ph2a patients with
C. difficile Infection clinical trials
- Extends research on ibezapolstat's selective activity compared
to healthy bacteria within the gut microbiome in the treatment of
CDI
STATEN
ISLAND, N.Y., Oct. 17,
2022 /PRNewswire/ -- Acurx Pharmaceuticals, Inc.
(NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage
biopharmaceutical company developing a new class of antibiotics for
difficult-to-treat bacterial infections, today announced that one
scientific oral presentation and one scientific poster highlighting
new information about its lead antibiotic ibezapolstat relating to
its selectivity against Gram-positive gut microbiota will be
presented at the Infectious Disease Society of America (IDSA)
IDWeek™ 2022 Conference being held October 19-23, 2022 in Washington, DC on the following day/times:
Oral Presentation:
Thursday, October 20, 8:40 a.m.
EDT
Title: Development Update on
Ibezapolstat for the Treatment of Clostridioides difficile
infection: Focus on the Microbiome
Presenter: Kevin Garey, PharmD, FIDSA Professor and Chair,
University of Houston College of
Pharmacy
Location: 145 AB
Poster Presentation:
Thursday, October 20, 12:15 to 1:30 p.m.
Poster
Title: Investigating the Gram-Positive
Selective Spectrum of Ibezapolstat, a First-in-Class
DNA Polymerase IIIC (Pol IIIC) Inhibitor
Presenter: Kevin Garey, PharmD, FIDSA Professor and Chair,
University of Houston College of
Pharmacy
Location: Poster Session: New Antimicrobial Drug
Development; Hall B and C, #521
The poster and presentation will be made available on the Acurx
Pharmaceuticals website following their respective
presentations at the conference.
About Ibezapolstat
Ibezapolstat is a novel, orally administered antibiotic being
developed as a Gram-Positive Selective Spectrum (GPSS™)
antibacterial. It is the first of a new class of DNA polymerase
IIIC inhibitors under development by Acurx
to treat bacterial infections. Ibezapolstat's unique
spectrum of activity, which
includes C. difficile but spares other
Firmicutes and the important
Actinobacteria phyla, appears
to contribute to the maintenance of a healthy
gut microbiome.
The Company currently is enrolling patients in a Ph2b
clinical trial of ibezapolstat to treat patients with C.
difficile infection (CDI). The Company
successfully completed Phase 1 and Phase 2a clinical
trials of ibezapolstat. The Phase 2a trial demonstrated
100% clinical cure and 100% sustained clinical cure in patients
with CDI, along with beneficial microbiome changes during treatment
including overgrowth of Actinobacteria and Firmicutes phylum
species while on therapy and new findings which demonstrate
potentially beneficial effects on bile acid metabolism. The Ph2b
clinical trial is designed to enroll 64 patients and is a
randomized (1:1), non-inferiority, double-blind trial of oral
ibezapolstat compared to oral vancomycin, a standard of care
to treat CDI.
In June 2018, ibezapolstat was
designated by the U.S. Food and Drug Administration (FDA) as a
Qualified Infectious Disease Product (QIDP) for the treatment of
patients with CDI and will be eligible to benefit from the
incentives for the development of new antibiotics established under
the Generating New Antibiotic Incentives Now (GAIN) Act. In January
2019, FDA granted
"Fast Track" designation to ibezapolstat for the treatment
of patients with CDI. The CDC has designated C.
difficile as an urgent threat highlighting the need for
new antibiotics to treat CDI.
About the IDSA and
IDWeek
The Infectious Diseases Society of America
(IDSA) is a community of over 12,000 physicians,
scientists and public health experts who specialize in infectious
diseases. Our mission is to improve the health of individuals,
communities, and society by promoting excellence in patient care,
education, research, public health, and prevention relating to
infectious diseases. IDWeek is the joint annual meeting of the
Infectious Diseases Society of America (IDSA), Society for
Healthcare Epidemiology of America (SHEA), the HIV Medicine
Association (HIVMA), the Pediatric Infectious Diseases Society
(PIDS), and the Society of Infectious Diseases Pharmacists
(SIDP).
About Clostridioides difficile Infection
(CDI). According to the 2017 Update (published
February 2018) of the Clinical
Practice Guidelines for C. difficile
Infection by the Infectious Diseases Society of
America (IDSA) and Society or Healthcare Epidemiology of
America (SHEA), CDI remains a significant medical problem in
hospitals, in long-term care facilities and in the community. C.
difficile is one of the most common causes of health care-
associated infections in U.S. hospitals (Lessa, et al, 2015, New
England Journal of Medicine). Recent estimates suggest C. difficile
approaches 500,000 infections annually in the U.S. and is
associated with approximately 20,000 deaths annually. (Guh, 2020,
New England Journal of Medicine). Based on internal estimates, the
recurrence rate of two of the three antibiotics currently used to
treat CDI is between 20% and 40% among approximately 150,000
patients treated. We believe the annual incidence of CDI in the
U.S. approaches 600,000 infections and a mortality rate of
approximately 9.3%.
About the Microbiome in Clostridioides difficile
Infection (CDI) and Bile Acid Metabolism
C.
difficile can be a normal component of the healthy gut
microbiome, but when the microbiome is thrown out of balance, the
C. difficile can thrive and cause an infection. After colonization
with C. difficile, the organism produces and releases the
main virulence factors, the two large clostridial toxins A (TcdA)
and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200;
doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins
that bind to human intestinal epithelial cells and are responsible
for inflammation, fluid and mucous secretion, as well as damage to
the intestinal mucosa.
Bile acids perform many functional roles in the GI tract, with
one of the most important being maintenance of a healthy microbiome
by inhibiting C. difficile growth. Primary bile acids, which
are secreted by the liver into the intestines, promote germination
of C. difficile spores and thereby increase the risk of
recurrent CDI after successful treatment of an initial episode. On
the other hand, secondary bile acids, which are produced by normal
gut microbiota through metabolism of primary bile acids, do not
induce C. difficile sporulation and therefore protect
against recurrent disease. Since ibezapolstat treatment leads to
minimal disruption of the gut microbiome, bacterial production of
secondary bile acids continues which may contribute to an
anti-recurrence effect.
About the Ibezapolstat Phase 2 Clinical Trial
The
multicenter, open-label single-arm segment of this study (Phase 2a)
is to be followed by a double- blind, randomized, active-controlled
segment (Phase 2b) which, together,
comprise the Phase 2 clinical trial. The Phase 2 clinical trial is
designed to evaluate ibezapolstat in the treatment of CDI. Phase 2a
of this trial is completed and was an open-label cohort of up to 20
subjects from study centers in the United
States. In this cohort, 10 patients with diarrhea caused by
C. difficile were treated with ibezapolstat 450 mg orally,
twice daily for 10 days. All patients were followed for recurrence
for 28± 2 days. Per protocol, after 10 patients of the projected 20
Phase 2a patients completed treatment, the Trial Oversight
Committee assessed the safety and tolerability and made its
recommendation regarding early termination of the Phase 2a study.
Based on the recommendation of Acurx's Scientific Advisory Board
(SAB) and Trial Oversight Committee, we terminated enrollment in
Phase 2a early and are now advancing to Phase 2b. The SAB unanimously supported the early
termination of the Phase 2a trial after 10 patients were enrolled
in the trial instead of 20 patients as originally planned. The
early termination was based on the evidence of meeting the primary
and secondary endpoints of eliminating the infection (100%), with
no recurrences of infection (100%), and with an acceptable adverse
event profile. In the upcoming Phase 2b, approximately 64 additional patients with CDI
will be enrolled and randomized in a 1:1 ratio to either
ibezapolstat 450 mg every 12 hours or vancomycin 125mg orally every
6 hours, in each case, for 10 days and followed for 28 ± 2 days
following the end of treatment for recurrence of CDI. The two
treatments will be identical in appearance, dosing times, and
number of capsules administered to maintain the blind. This Phase 2
clinical trial also will evaluate pharmacokinetics (PK) and
microbiome changes and continue to test for anti-recurrence
microbiome properties, including the change from baseline in alpha
diversity and bacterial abundance, especially overgrowth of healthy
gut microbiota Actinobacteria and Firmicute phylum species during
and after therapy.
About Acurx Pharmaceuticals,
Inc.
Acurx Pharmaceuticals is a clinical stage biopharmaceutical
company focused on developing new antibiotics for difficult to
treat infections. The Company's approach is to develop antibiotic
candidates that target the DNA polymerase IIIC enzyme and its
R&D pipeline includes antibiotic product candidates that target
Gram-positive bacteria, including Clostridioides difficile,
methicillin-resistant Staphylococcus aureus (MRSA), vancomycin
resistant Enterococcus (VRE) and drug-resistant Streptococcus
pneumoniae (DRSP).
To learn more about Acurx Pharmaceuticals and its product
pipeline, please visit www.acurxpharma.com.
Forward-Looking
Statements
Any statements in this press release about our future
expectations, plans and prospects, including statements regarding
our strategy, future operations, prospects, plans and objectives,
and other statements containing the words "believes,"
"anticipates," "plans," "expects," and similar expressions,
constitute forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of various important factors, including:
whether ibezapolstat will benefit from the QIDP designation;
whether ibezapolstat will advance through the clinical trial
process on a timely basis; whether the results of the clinical
trials of ibezapolstat will warrant the submission of applications
for marketing approval, and if so, whether ibezapolstat will
receive approval from the FDA or equivalent foreign regulatory
agencies where approval is sought; whether, if ibezapolstat obtains
approval, it will be successfully distributed and marketed; and
other risks and uncertainties described in the Company's annual
report filed with the Securities and Exchange Commission on Form
10-K for the year ended December 31,
2021, and in the Company's subsequent filings with the
Securities and Exchange Commission. Such forward-looking statements
speak only as of the date of this press release, and Acurx
disclaims any intent or obligation to update these forward-looking
statements to reflect events or circumstances after the date of
such statements, except as may be required by law.
Investor Contact:
Acurx Pharmaceuticals, Inc.
David P. Luci, President &
CEO
Tel: 917-533-1469
Email: davidluci@acurxpharma.com
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SOURCE Acurx Pharmaceuticals, Inc.