STATEN ISLAND,
N.Y., Nov. 8,
2021 /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,
announced today that new microbiome data from its
Phase 2a clinical trial for C. difficile Infection (CDI)
were presented at the 9th International C. diff Conference
& Health Expo entitled: "Can Emerging Microbiome Findings
Contribute to CDI Anti-Recurrence Effect?" The presentation was
made on November 5, 2021, by Dr.
Kevin Garey, Professor and Chair,
University of Houston College of
Pharmacy and the Principal Investigator for microbiome aspects of
the ibezapolstat clinical trial program.
Phase 2a data demonstrated complete eradication of colonic C.
difficile by day three of treatment with ibezapolstat as well
as the observed overgrowth of healthy gut microbiota,
Actinobacteria and Firmicute phyla species, during and after
therapy. Very importantly, emerging data show an increased
concentration of secondary bile acids during and following
ibezapolstat therapy which is known to correlate with colonization
resistance against C. difficile. Additionally, a decrease in
primary bile acids and the favorable increase in the ratio of
secondary-to-primary bile acids suggest that ibezapolstat may
reduce the likelihood of CDI recurrence when compared to
vancomycin.
Dr. Garey's Presentation can be viewed on the company's website
at www.acurxpharma.com, Tab: News Media, Presentations.
According to Dr. Garey, "The totality of pre-clinical and
clinical data-to-date demonstrate that ibezapolstat fulfills the
three key criteria for an ideal anti-CDI antibiotic: Ibezapolstat
achieves high colonic concentrations with minimal systemic
absorption; it has potent activity against C. difficile
while, in contrast to oral vancomycin, causes minimal disruption of
the gut microbiome; and it shows a potentially beneficial effect on
gut bile acid metabolism. Taken together, these features contribute
to the observed clinical success rate and make ibezapolstat, which
also shows good tolerability, an attractive potential therapeutic
option for CDI."
The Company's upcoming Phase 2b
segment of this clinical trial also will evaluate pharmacokinetics
(PK) and microbiome changes from baseline and continue to test for
anti-recurrence microbiome properties seen in the Phase 2a trial,
including the treatment-related changes in alpha diversity and
bacterial abundance and effects on bile acid metabolism.
Robert J. DeLuccia, Executive
Chairman of Acurx, stated, "We are particularly excited by these
results in our Phase 2a CDI patients which are consistent with the
favorable microbiome profile when compared with vancomycin in our
earlier Phase 1 healthy volunteer trial; particularly this newest
information on the beneficial effect on bile acids." He
further stated that "We look forward to beginning enrollment in our
Phase 2b trial this month, which will
compare ibezapolstat to vancomycin, the standard of care in
CDI."
About the C. diff Conference: Sponsored by the C Diff
Foundation, clinical professionals gathered for eleven (11)
hours and presented up-to-date data to expand on the existing
knowledge and raise awareness of the urgency focused on, but not
limited to, C. difficile infection (CDI) Prevention,
Treatments, Research, Diagnostics, Clinical Trials, AMR, and
Environmental Safety.
Additionally, the Company recognizes the month of November as
C. difficile Awareness Month as designated by the US Centers
for Disease Control and Prevention (CDC) and supports the work of
the C Diff Foundation in educating and advocating for the
Prevention, Treatments, Clinical Trials, and Environmental Safety
of Clostridioides difficile (C. difficile) Infections
worldwide. https://cdifffoundation.org/.
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 125 mg 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.
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 United States Food and Drug
Administration or equivalent foreign regulatory agencies where
approval is sought; whether, if ibezapolstat obtains approval, it
will be successfully distributed and marketed; and other factors.
In addition, the forward-looking statements included in this press
release represent our views as of November
8, 2021. We anticipate that subsequent events and
developments will cause our views to change. However, while we may
elect to update these forward- looking statements at some point in
the future, we specifically disclaim any obligation to do so.
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.