STATEN ISLAND, N.Y.,
Oct. 4, 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 a scientific abstract and poster
were presented on September
29th at the Infectious Disease Society of America
(IDSA) IDWeek™ 2021 Virtual
Conference entitled: "An Open-label Phase 2a study of Ibezapolstat,
a Unique Gram-positive Selective Spectrum (GPSS™) Antibiotic, for
Patients with Clostridioides difficile Infection."
These results were presented by Dr. Kevin
Garey, Professor and Chair, University
of Houston College of Pharmacy and the Principal
Investigator for microbiome aspects of the clinical trial program
for ibezapolstat.
The Company's upcoming Phase 2b
segment of this clinical trial will also evaluate pharmacokinetics
(PK) and microbiome changes from baseline and continue to test for
anti-recurrence microbiome properties seen in the Phase 1 trial,
including the treatment-related changes in alpha diversity and
bacterial abundance. The Phase 2a data demonstrated complete
eradication of colonic C. difficile by day three of
treatment as well as the observed overgrowth of healthy gut
microbiota Actinobacteria and Firmicute phyla species during and
after therapy. According to Dr. Garey, "The good
tolerability, promising efficacy outcomes, minimal systemic
exposure, and differential microbiome effects relative to
vancomycin all support the continued clinical development of
ibezapolstat. He added: "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.
Furthermore, ibezapolstat demonstrated decreased proteobacteria
overgrowth in contrast to vancomycin."
Robert J. DeLuccia, Executive
Chairman of Acurx, stated, "We are particularly excited by these
results in CDI patients which are consistent with the favorable
microbiome profile when compared with vancomycin in our earlier
Phase 1 healthy volunteer trial. He further stated that "We
look forward to beginning enrollment in our Phase 2b trial which will compare ibezapolstat to the
standard of care, vancomycin, and is expected to begin enrollment
this quarter."
Dr. Garey's E-Poster Scientific Exhibit can be viewed on the
company's website www.acurxpharma.com, Tab: News Media,
Presentations.
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)
C. difficile can sometimes 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.
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 will also 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 October
4, 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.