- |||||||||| Preclinical, Journal: The impact of ibezapolstat and other Clostridioides difficile infection-relevant antibiotics on the microbiome of humanized mice. (Pubmed Central) - Feb 25, 2025
Previous studies demonstrated that IBZ carries a favorable microbiome diversity profile compared to vancomycin (VAN)...Groups of germ-free (GF) mice received a fecal microbiota transplant from one of two healthy human donors and were subsequently exposed to either IBZ, VAN, fidaxomicin (FDX), metronidazole (MET), or no antibiotic (control)...In microbiome-humanized mice, IBZ and FDX had smaller effects on gut microbiome diversity than VAN and MET. Notable differences were observed between the microbiome of IBZ- and FDX-treated groups, which may allow for differentiation of these two antibiotics in future studies.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Preclinical, Journal: Microbiome impact of ibezapolstat and other Clostridioides difficile infection relevant antibiotics using humanized mice. (Pubmed Central) - Nov 22, 2024
Previous studies demonstrated IBZ carries a favorable microbiome diversity profile compared to vancomycin (VAN)...Groups of germ-free (GF) mice received a fecal microbiota transplant from one of two healthy human donors and were subsequently exposed to either IBZ, VAN, fidaxomicin (FDX), metronidazole (MET), or no antibiotic (control)...In microbiome-humanized mice, IBZ and FDX had smaller effects on gut microbiome diversity compared to VAN and MET. Notable differences were observed between the microbiome of IBZ- and FDX-treated groups, which may allow for differentiation of these two antibiotics in future studies.
- |||||||||| Review, Journal: Fighting against Clostridioides difficile infection: Current medications. (Pubmed Central) - Jun 17, 2024
Currently, researchers are investigating therapeutic antibacterial drugs (e.g., teicoplanin, ridinilazole, ibezapolstat, surotomycin, cadazolid, and LFF571), preventive medications against recurrence (e.g., Rebyota, Vowst, VP20621, VE303, RBX7455, and MET-2), primary prevention strategies (e.g., vaccine, ribaxamase, and DAV132) and other anti-CDI medications in the preclinical stage (e.g., Raja 42, Myxopyronin B, and bacteriophage). This narrative review summarizes current medications, including newly marketed drugs and products in development against CDI, to help clinicians treat CDI appropriately and to call for more research on innovation.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Trial completion: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - May 14, 2024
P2, N=32, Completed,
This narrative review summarizes current medications, including newly marketed drugs and products in development against CDI, to help clinicians treat CDI appropriately and to call for more research on innovation. Active, not recruiting --> Completed
- |||||||||| Review, Journal: Clostridioides difficile resistance to antibiotics, including post-COVID-19 data. (Pubmed Central) - Aug 29, 2023
Resistance to erythromycin (>60-88%), rifampin (>23-55.0%), imipenem (0.6 to?>?78% in a clone), tigecycline (0-<5.0%), and fidaxomicin (0-2%) was also found...New approaches, including biotherapeutics (Rebyota), strains, antibiotics (ridinilazole and ibezapolstat), and monoclonal antibodies/cocktails merit further evaluation...Post-COVID-19 resistance should be separately presented. Some discrepancies between vancomycin and metronidazole results need to be clarified.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Trial completion date, Trial primary completion date: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - Jul 20, 2023
P2b, N=74, Recruiting,
Some discrepancies between vancomycin and metronidazole results need to be clarified. Trial completion date: Aug 2023 --> Feb 2024 | Trial primary completion date: May 2023 --> Oct 2023
- |||||||||| Review, Journal: Antibiotics with novel mode of action as new weapons to fight antimicrobial resistance. (Pubmed Central) - May 7, 2023
Today, the pipeline of potential new treatments with these characteristics includes promising compounds such as gepotidacin, zoliflodacin, ibezapolstat, MGB-BP-3, CRS-3123, afabicin and TXA-709, which are currently in clinical trials, and lefamulin, which has been recently approved by FDA and EMA. In this review, we report the chemical synthesis, mode of action, structure-activity relationships, in vitro and in vivo activities as well as clinical data of these eight small molecules listed above.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Trial completion date, Trial primary completion date: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - Feb 1, 2023
P2b, N=74, Recruiting,
In this review, we report the chemical synthesis, mode of action, structure-activity relationships, in vitro and in vivo activities as well as clinical data of these eight small molecules listed above. Trial completion date: Feb 2023 --> Aug 2023 | Trial primary completion date: Dec 2022 --> May 2023
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
P2a data, PK/PD data, Journal: Efficacy, Safety, Pharmacokinetics, and Microbiome Changes of Ibezapolstat in Adults with Clostridioides difficile Infection: A Phase 2a Multicenter Clinical Trial. (Pubmed Central) - Oct 5, 2022
In this phase 2a study, 10 of 10 patients achieved SCC, demonstrated favorable pharmacokinetics, minimal AEs, and beneficial microbiome and bile acids results. These results support continued clinical development.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Ibezapolstat; Acurx Pharmaceuticals (145 AB) - Jul 23, 2022 - Abstract #IDWeek2022IDWEEK_100;
This novel omics approach may allow for better and earlier prediction of anti-CDI recurrence effects for antibiotics in the clinical development pipeline. Sponsored by Acurx Pharmaceuticals
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Enrollment open, Trial completion date, Trial primary completion date: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - Dec 17, 2021
P2b, N=74, Recruiting,
Trial completion date: Aug 2022 --> Feb 2023 | Trial primary completion date: Jun 2022 --> Dec 2022 Active, not recruiting --> Recruiting | Trial completion date: Mar 2022 --> Aug 2022 | Trial primary completion date: Dec 2021 --> Jun 2022
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Clinical, P1 data, PK/PD data, Journal: A randomized, double-blind, placebo-controlled, single and multiple ascending dose Phase 1 study to determine the safety, pharmacokinetics and food and faecal microbiome effects of ibezapolstat administered orally to healthy subjects. (Pubmed Central) - Jun 26, 2021
Ibezapolstat was shown to be safe and well tolerated, with minimal systemic exposure, high stool concentrations and a distinct microbiome profile compared with oral vancomycin. These results support further clinical development of ibezapolstat for patients with C. difficile infection.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - Dec 19, 2020
P2b, N=74, Active, not recruiting,
This hypothesis is being tested in a Phase 2 CDI trial of ibezapolstat Recruiting --> Active, not recruiting | N=20 --> 74 | Trial completion date: Sep 2021 --> Mar 2022 | Trial primary completion date: Jul 2021 --> Dec 2021
- |||||||||| Review, Journal: Investigational Treatment Agents for Recurrent Clostridioides difficile Infection (rCDI). (Pubmed Central) - Nov 1, 2020
Various emerging potential therapies with narrow spectrum of activity and little systemic absorption that are in development include 1) Ibezapolstat (formerly ACX-362E), MGB-BP-3, and DS-2969b-targeting bacterial DNA replication, 2) CRS3213 (REP3123)-inhibiting toxin production and spore formation, 3) ramizol and ramoplanin-affecting bacterial cell wall, 4) LFF-571-blocking protein synthesis, 5) Alanyl-L-Glutamine (alanylglutamine)-inhibiting damage caused by C. difficile by protecting intestinal mucosa, and 6) DNV3837 (MCB3681)-prodrug consisting of an oxazolidinone-quinolone combination that converts to the active form DNV3681 that has activity in vitro against C. difficile. This review article provides an overview of these developing drugs that can have potential role in the treatment of rCDI and in lowering recurrence rates.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Review, Journal: Discovery and development of DNA polymerase IIIC inhibitors to treat Gram-positive infections. (Pubmed Central) - Sep 24, 2020
The recent entry of this new class into human trials may herald the introduction of novel drugs whose novel molecular target precludes cross-resistance with existing antibiotic classes. This review therefore examines the evolution of DNA pol IIIC inhibitors from the discovery of 6-(p-hydroxyphenylazo)uracil (HPUra) in the 1960s to the development of current first-in-class N7-substituted guanine drug candidate ACX-362E, now under clinical development for the treatment of Clostridioides difficile infection.
- |||||||||| ibezapolstat (ACX-362E) / Acurx Pharma
Enrollment open: ACX-362E [Ibezapolstat] for Oral Treatment of Clostridioides Difficile Infection (clinicaltrials.gov) - Mar 10, 2020
P2b, N=20, Recruiting,
This review therefore examines the evolution of DNA pol IIIC inhibitors from the discovery of 6-(p-hydroxyphenylazo)uracil (HPUra) in the 1960s to the development of current first-in-class N7-substituted guanine drug candidate ACX-362E, now under clinical development for the treatment of Clostridioides difficile infection. Not yet recruiting --> Recruiting
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