Time to resolution of diarrhea (TTRD) (days 0-12) Safety (day 38)
Microbiologic eradication (days 0-12)
anaerobic culture on CCFA
Microbiome changes (days 0-12)
qPCR and 16S rRNA
ClinicalTrials.gov ID NCT04247542
Consort Diagram
Patients enrolled (n=32)
IBZ
VAN
(n=18)
(n=14)
Completed
Completed
study (n=16*)
study (n=14)
Modified intent to treat population
*One patient given IBZ withdrew consent prior to first dose; one patient given IBZ had a history of underlying irritable bowel disease and was excluded from analysis.
Demographics and Baseline Information
IBZ (n=16)
VAN (n=14)
P value
Age, years
64±13
62±10
0.57
>75 y/o
5 (31.2%)
2 (14.3%)
Female
13 (81%)
11 (79%)
0.85
White
16 (100%)
13 (93%)
0.27
Hispanic or Latino
11 (69%)
11 (79%)
0.54
Charlson Comorbidity index
2.6±1.5
2.2±1.5
0.47
Number of UBMs at baseline
6 (3-15)
6 (4-13)
Median (minimum, maximum)
Baseline C. difficile ribotype strains
F014-020
0
3
F027
1
2
F106
3
1
F002
1
1
F116
0
1
Other
6
3
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Acurx Pharmaceuticals Inc. published this content on
16 July 2024 and is solely responsible for the information contained therein. Distributed by
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Acurx Pharmaceuticals, Inc. is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. It develops antibiotic candidates with a Gram-positive selective spectrum (GPSS) that block the active site of the Gram positive specific bacterial enzyme deoxyribonucleic acid (DNA) polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its research and development (R&D) pipeline include antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile (C. difficile), methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP). Its lead antibiotic candidate, ibezapolstat targets the pol IIIC enzyme. Phase II clinical data validate the efficacy of its lead antibiotic candidate, as well as pol IIIC as an appropriate bacterial target.