- Ibezapolstat is currently enrolling in a Phase 2b trial for C. difficile infection in
U.S. centers across the country and nearing its goal to reach a
targeted 36 patients at which point an Interim Analysis of the
unblinded primary clinical endpoint and safety data will be
reviewed by an Independent Data Monitoring Committee
- Ibezapolstat has received FDA QIDP and Fast-Track
Designation
- Also presented was an update on the Company's pre-clinical
antibiotic program in Lead Optimization stage for systemic
gram-positive bacterial infections, including Acute Bacterial Skin
and Skin Structure Infections caused by MRSA
- The company's preclinical pipeline also targets systemic
infections caused by other gram-positive bacteria such as VRE
and DRSP which are expected to be QIDP and Fast-Track eligible as
product candidates advance in development
STATEN
ISLAND, N.Y., Sept. 12,
2023 /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 a
presentation was given by Acurx Executive Chairman, Robert J. DeLuccia, at the World Antimicrobial
Resistance Scientific Congress on September
7, 2023. In his presentation at the Innovation
Showcase session, he highlighted that the Company anticipates
completing enrollment of the 36 patients required for an interim
review of the Phase 2b data by the
Independent Data Monitoring Committee (IDMC) in the coming
months.
Mr. DeLuccia also presented an update on the Company's
preclinical GPSS™ (Gram Positive Selective Spectrum) program for
systemic oral and IV treatment of other gram-positive infections
including MRSA, VRE and DRSP. Mr. DeLuccia summarized the
progress stating that "Our potential lead compound meets
Theurezbacher's criteria for antibiotic innovation in that it is a
new chemical class, has novel mechanism and bacterial target, and
has not shown cross-resistance in early in vitro microbiology
studies." He further stated: "Having established clinical
validation of the pol IIIC bacterial target in a Ph2a
proof-of-principal trial showing 100% cure of C. difficile
Infection, with no recurrence after 30 days' follow up, we have
made substantial progress toward lead compound selection of our
gram-positive IV and oral compounds. We've made significant
improvements in invitro and invivo safety and have demonstrated
oral and IV efficacy in a number of mouse infection models. Our
current focus is to prioritize the oral form for acute bacterial
skin and skin structure staph infections, including MRSA, to speed
lead product selection and advancement to the clinic."
The presentation is available
on the Company's website www.acurxpharma.com.
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.
The FDA has accepted the Company's plan to have an Independent
Data Monitoring Committee (IDMC) conduct an interim review of
clinical outcome from the ongoing Ph2b clinical trial of patients
with C. difficile Infection (CDI). The interim review will
be conducted upon reaching enrollment of 36 patients in total.
FDA's acceptance was based on the Company's filing of a protocol
amendment to its Investigational New Drug Application (IND) with
FDA in January 2023. The Company's
filing and intention for the IDMC to conduct an interim review of
data was based on the observed blinded data to date from the
ongoing Ph2b clinical trial at that time. Upon conducting the
interim review, the IDMC will determine and recommend to the
Company whether the most appropriate course of action is to
terminate the Ph2b clinical trial early due to success, as the
Company had done with the Ph2a clinical trial, or to continue
patient enrollment. The Company intends to report available data
promptly after the IDMC conducts this interim review. The IDMC
initial organizational meeting was conducted in March 2023 and it has completed all
organizational matters required to ensure readiness for data
review.
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 World Antimicrobial Resistance Congress
Since 2015, the World Antimicrobial Resistance Congress has
attracted top thought leaders, hospitals, companies, and
policymakers as the annual, go-to event in the Antimicrobial
Resistance (AMR) space. It has grown into the most impactful event
in advancing solutions to combat current and future pressing global
health crises. Diagnostic developers, antibiotic biotechs
& pharmaceutical companies, stewardship technologies, access
firms, and many more, rely on our event for business development
opportunities, networking and showcasing of new products and
solutions. Over 1,300 attendees were expected to attend with over
200 speakers presenting over the two-day conference held in
Philadelphia, PA on September 7-8, 2023.
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. Beneficial effects of bile acids include a
decrease in primary bile acids and an increase in secondary bile
acids in patients with CDI, which was observed in the Company's
Ph2a trial results and previously reported. (CID, 2022)
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 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,
2022, 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.