STATEN ISLAND,
N.Y., Nov. 1,
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)
will be presented at the 9th Annual International C. diff
Conference & Health Expo. taking place virtually on
November 4-5, 2021.
Title: Ibezapolstat Update: Can Emerging Microbiome
Findings Contribute to CDI Anti-Recurrence Effect?"
Presenting Author: Professor Kevin Garey, PharmD,
MS, Chair of the Department of Clinical Sciences and
Administration and Professor of Pharmacy Practice, University of Houston College of Pharmacy
Date: Friday, November 5, 2021; 11:20am – 11:40am Eastern
Time
Registration: Registration is complimentary
https://whova.com/portal/registration/aicdc_202111/
About the C. diff Conference and C Diff Foundation: At
the C. diff Conference, clinical professionals will gather for
eleven (11) hours to present 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. The C. diff Conference is sponsored by the C.
Diff Foundation.
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 has
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 completed
and will 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 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 November
1, 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.