2024 Ibezapolstat - Ibezapolstat for Oral Treatment of C. difficileInfection: Phase 2b Double-Blind Vancomycin-Controlled Segment Phase 3 Non-inferiority to vancomycin Phase 3 ~ N patients - TBD §Management will continue to pursue non-dilutive grants for late-stage clinical trials. Ibezapolstat Phase 2b Clinical Trial Design Acurx 7 §Invitro potency vs C. difficile …Web

 
Acurx Announces Positive Top-Line Ibezapolstat Phase 2 Efficacy Results with 96% Clinical Cure Rate in Patients with C. difficile Infection . Nov 2, 2023. Acurx Pharmaceuticals to Discuss Third Quarter 2023 Financial Results and Provide Business Update . Oct 25, 2023. Acurx Announces Ibezapolstat Scientific Posters and Presentations at .... Ibezapolstat

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 ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b ) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...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 ...New emerging, favorable microbiome data to be presented from previously completed Ph1 healthy volunteers and Ph2a patients with C. difficile Infec...Webibezapolstat (ACX-362E) Acurx Pharmaceuticals Clostridioides difficile infections Phase II (Pol IIIC inhibitor) White Plains, NY (Fast Track) www.acurxpharma.com ibrexafungerp SCYNEXIS acute vulvovaginal candidiasis application submitted (glucan synthase inhibitor) Jersey City, NJ (Fast Track) www.scynexis.com ORPHAN DRUGIbezapolstat | C18H20Cl2N6O2 | CID 136022209 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities ... On November 2, 2023, we reported top-line data from the Phase 2 clinical trial including the ibezapolstat clinical cure rate at end of treatment, or EOT, of 96% (25/26) including 100% in Phase 2a (10/10) and 94% in Phase 2b (15/16) as well as the cure rate for oral vancomycin at EOT of 100% (14/14). No safety concerns were reported in either arm …About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, ...Oct 19, 2023 · Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome; A ... STATEN ISLAND, N.Y., Nov. 14, 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, announced today certain financial and operational results for the third …WebAbout the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...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. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP ...We would like to show you a description here but the site won’t allow us. 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.In the currently enrolling Phase 2b, trial segment, 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 ...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 ...Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome; A ...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.3 days ago ... Additionally, data showed ibezapolstat was safe and tolerable, with only 3 patients experiencing mild gastrointestinal-related adverse events ( ...Dec 1, 2020 · Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period. About Ibezapolstat Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is ...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).Ibezapolstat was minimally absorbed in a hamster model, leading to high colonic and low systemic concentrations and was shown to be effective for CDI . A phase …Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in ...In October, ACXP released additional positive clinical data evaluating ibezapolstat, its orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. Following precedent, the data was impressive. Two presentations, one a scientific oral presentation and the other a poster, detailed new ...Those findings support the continued development of ibezapolstat as a potential first-in-class antibiotic to treat C. difficile infection. Vancomycin is the current standard of care. To date, ACXP’s ibezapolstat is besting vancomycin on multiple fronts. A Changing Of The Antibiotics Guard. But that shouldn’t be surprising.Ibezapolstat was as effective as the currently-used anti-C. difficile agents fidaxomicin, vancomycin and metronidazole to reduce biofilm-embedded C. difficile quantity and biofilm biomass; Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-Clostridioides difficile Agents. Presented by Jinhee Jo, University of Houston College of PharmacyOct 19, 2023 · Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome A ... 17 Nov 2023 ... Acurx Pharmaceuticals announced efficacy results from the Phase 2 clinical trials for their narrow spectrum antibiotic ibezapolstat for the ...Jul 12, 2021 · Article. Acurx Pharmaceuticals has filed a provisional patent application with the United States Patent and Trademark Office for the use of ibezapolstat in the treatment of Clostridioides difficile ( C. difficile ) Infection (CDI). This action follows a recently completed phase 2a clinical trial, which demonstrated that 100% of the 10 enrolled ... Jul 1, 2021 · Methods: As part of the completed Phase 1 clinical study of ibezapolstat, stool samples were collected daily from healthy volunteers given ten days of ibezapolstat (300 or 450 mg given twice daily ... FDA has accepted an Interim Analysis Plan for an IDMC to assess clinical outcome when 36 patients are enrolled in the Company's Ph2b clinical trial of ibezapolstat in patients with CDIA scientific...New emerging, favorable microbiome data to be presented from previously completed Ph1 healthy volunteers and Ph2a patients with C. difficile Infection clinical trialsExtends research on...WebIn the currently enrolling Phase 2b, trial segment, 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 ...Aug 1, 2020 · The killing of C. difficile by ibezapolstat was observed to occur at concentrations similar to its MIC, as demonstrated by MBC:MIC ratios and reflected in time-kill kinetic assays. This activity highlights the therapeutic potential of ibezapolstat for the treatment of CDI. Ibezapolstat designed as a small-molecule DNA Pol IIIC inhibitor based upon competitive inhibition of dGTP. Preclinical development strongly supported continued development into phase I/II clinical trials. To summarize data from the ongoing ibezapolstat clinical development program. Pre-clinical development . OBJECTIVES. Primary: To determine …WebPlasma levels of ibezapolstat ranged from 233 to 578 ng/mL while mean (SD) fecal levels were 416 (494) µg/g stool by treatment day 3 and >1000 µg/g stool by days 8-10. A rapid increase in alpha diversity in the fecal microbiome was noted after starting ibezapolstat therapy, which was maintained after completion of therapy.Ibezapolstat was minimally absorbed in a hamster model, leading to high colonic and low systemic concentrations and was shown to be effective for CDI . A phase …We would like to show you a description here but the site won’t allow us.Prior to that, Mr. Shawah served as Chief Accounting Officer of Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX) from 2014 until April 2017 when Dipexium Pharmaceuticals was sold to PLX Pharma (Nasdaq: PLXP). Further, Mr. Shawah has served as Vice President of Baldwin Pearson & Co, a commercial real estate firm. From August 2018 to December 2018 ...We would like to show you a description here but the site won’t allow us. Ibezapolstat achieved high stool concentrations and plasma concentrations that did not exceed 1 ug/mL. Favorable changes to the microbiome were observed, most notably C. difficile eradication by day 3 and an increased proportion of healthy microbiota, including Clostridiales order taxa known to metabolize primary bile acids to secondary bile ...David P. Luci, the Company's President and Chief Executive Officer, stated: "We also look forward to reporting the full ibezapolstat data which will include the most extensive data for any antibiotic on sustained clinical cure to date in patients with CDI, as well as a comparison of the effect on the microbiome between oral ibezapolstat and oral …WebAcurx Pharmaceuticals. Acurx Pharmaceuticals is a publicly held, clinical stage biopharmaceutical company developing a new class of antibiotics for infections caused by bacteria listed as priority pathogens by the World Health Organization, Centers for Disease Control and Prevention, and Food and Drug Administration.Download Table | Proportional changes in taxa in healthy subjects given vancomycin or one of two doses of ibezapolstat a from publication: Functional and Metagenomic Evaluation of Ibezapolstat for ...WebThe company ended the year with cash totaling $9.1 million compared to $13 million as of December 31, 2021. Research and development expenses for the 3 months ended December 31, 2022, were $1.4 ...WebMar 6, 2023 · In the currently enrolling Phase 2b, trial segment, 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 ... 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 ...Ibezapolstat was as effective as the currently-used anti-C. difficile agents fidaxomicin, vancomycin and metronidazole to reduce biofilm-embedded C. difficile quantity and biofilm biomass; Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-Clostridioides difficile Agents. Presented by Jinhee Jo, University of Houston College of …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. In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP ...Ibezapolstat (IBZ) is currently in a phase 2 trial against Clostridioides difficile infection, and inhibits bacterial DNA polymerase IIIC (pol IIIC) by interfering with addition of guanine (G) to ...In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute ...Jul 22, 2022 · Stool samples were evaluated for microbiome changes and bile acid concentrations. Ibezapolstat 450 mg and vancomycin, but not ibezapolstat 300 mg, showed statistically significant changes in alpha diversity over time compared to that of a placebo. Beta diversity changes confirmed that microbiota were significantly different between study groups. Investigational antibiotic ibezapolstat is reported to be the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in C difficile. This therapy is a first-in-class of a new class of Pol IIIC inhibitors in phase 2 trials with this unique mechanism of action.About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b ) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...Ibezapolstat (previously known as ACX 362E) is an orally administered DNA polymerase IIIC (pol IIIC) inhibitor, being developed by Acurx Pharmaceuticals, ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non ...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 ...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 ...The results were incredibly promising, showcasing the potential of ibezapolstat as a groundbreaking solution. One of the key findings from the study was the impressive Clinical Cure rate. Out of the 26 patients who received ibezapolstat treatment in Phases 2a and 2b, an outstanding 96% experienced clinical cure after just 10 days of …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.New emerging, favorable microbiome data to be presented from previously completed Ph1 healthy volunteers and Ph2a patients with C. difficile Infec...WebApr 19, 2023 · 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. New emerging, favorable microbiome data to be presented from previously completed Ph1 healthy volunteers and Ph2a patients with C. difficile Infec...WebFunctional and metagenomic evaluation of ibezapolstat for early evaluation of anti-recurrence effects in Clostridioides difficile infection. J McPherson, C Hu, ...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 ...FDA Accepts Interim Analysis Plan for Ongoing Phase 2b Ibezapolstat Clinical Trial and Acurx Announces Presentations at ECCMID 2023 Scientific Conference.Acurx Pharmaceuticals, Inc. gab die Wirksamkeitsergebnisse der klinischen Phase-2-Studie für Ibezapolstat zur Behandlung von C. difficile-Infektionen ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...Nov 19, 2023 · Ibezapolstat is a small molecule commercialized by Acurx Pharmaceuticals, with a leading Phase II program in Clostridioides difficile Infections (Clostridium difficile Associated Disease). According to Globaldata, it is involved in 3 clinical trials, of which 1 was completed, 1 is planned, and 1 was terminated. 19 Nov 2023 ... ... ibezapolstat, for the treatment of C difficile Infection (CDI). Specifically, in 26 ibezapolstat-treated patients in phases 2a and 2b, the ...Ibezapolstat was as effective as the currently-used anti-C. difficile agents fidaxomicin, vancomycin and metronidazole to reduce biofilm-embedded C. difficile quantity and biofilm biomass; Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-Clostridioides difficile Agents. Presented by Jinhee Jo, University of Houston College of PharmacyDec 4, 2021 · Ibezapolstat was well tolerated with 1 adverse event (nausea) probably related to drug. Ibezapolstat systemic exposure was minimal with no plasma level reaching 1 ug/mL any time during therapy. Ibezapolstat colonic concentrations averaged 400 ug/g stool at day 3 and greater than 1,000 ug/g by day 10 of dosing. 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. About the ...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 ...WebAbout the Ibezapolstat Phase 2 Clinical TrialThe completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, ...WebIbezapolstat was as effective as the currently-used anti-C. difficile agents fidaxomicin, vancomycin and metronidazole to reduce biofilm-embedded C. difficile quantity and biofilm biomass; Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-Clostridioides difficile Agents. Presented by Jinhee Jo, University of Houston College of Pharmacyibezapolstat for the oral treatment for patients with CDI. FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orallyBackground. Ibezapolstat (IBZ) is a non-absorbable antimicrobial currently in phase 2 clinical trials for the treatment of Clostridioides difficile infection (CDI).In vitro and human studies have shown potent activity of IBZ against C. difficile but selective activity against other beneficial Gram-positive gut microbiota shown to reduce the risk of recurrent CDI.Oct 19, 2023 · Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome; A ... In the currently enrolling Phase 2b, trial segment, 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 ...In the currently enrolling Phase 2b, trial segment, 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 ...Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period.STATEN ISLAND, N.Y., July 1, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (Nasdaq ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of...Ibezapolstat

Dec 4, 2021 · Ibezapolstat was well tolerated with 1 adverse event (nausea) probably related to drug. Ibezapolstat systemic exposure was minimal with no plasma level reaching 1 ug/mL any time during therapy. Ibezapolstat colonic concentrations averaged 400 ug/g stool at day 3 and greater than 1,000 ug/g by day 10 of dosing. . Ibezapolstat

ibezapolstat

Nov 19, 2023 · Ibezapolstat is a small molecule commercialized by Acurx Pharmaceuticals, with a leading Phase II program in Clostridioides difficile Infections (Clostridium difficile Associated Disease). According to Globaldata, it is involved in 3 clinical trials, of which 1 was completed, 1 is planned, and 1 was terminated. Apr 19, 2023 · 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. Oct 19, 2023 · Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome A ... Ibezapolstat Vs. Vancomycin- A Phase 2b Trial Showdown. The new trial arm is a double-blind, randomized 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 a recurrence of CDI.Ibezapolstat hydrochloride | C18H21Cl3N6O2 | CID 136022208 - structure, chemical names, physical and chemical properties, classification, patents, literature ...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 ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...Ibezapolstat (ACX-362E) Dichlorobenzyl guanine (DCBG) C. difficile DNA polymerase IIIC: No: Yes: C. difficile: The discovery of penicillin later led to the creation of many derivatives, built with the intention of circumventing the issue of penicillin-resistant bacteria. 50 Further advances were also made in the development of antibiotics ...In the currently enrolling Phase 2b, trial segment, 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 ...PMC6440555. DOI: 10.7759/cureus.3977. Clostridium difficile is a gram-positive bacterium notorious for causing epidemic diarrhea globally with a significant health burden. The pathogen is clinically challenging with increasing antibiotic resistance and recurrence rate. We provide here an in-depth review of one particular strain/ribotype 027 ...WebThis drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon. Generic Name. Ibezapolstat. DrugBank Accession Number. DB16189. Background. Ibezapolstat is under investigation in clinical trial NCT04247542 (ACX-362E Ibezapolstat for Oral Treatment of Clostridioides Difficile Infection).Acurx Pharmaceuticals’ ibezapolstat completed primary and secondary treatment objectives in trial patients with a 100% success rate, successfully curing C. difficile infection in all ...About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show ...Mar 16, 2023 · About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non ... In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Additionally, due to slower than expected enrollment during ...In addition, in January 2019, FDA granted Fast Track designation to ibezapolstat for the oral treatment for patients with CDI. FDA's QIDP Designation provides that ibezapolstat will be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act).He further stated: "The totality of the data, including the pioneering vancomycin-controlled healthy volunteer study, suggests that ibezapolstat's effects on the gut microbiome could be predictive of an anti-recurrence effect in CDI patients." More simply stated, ibezapolstat is showing potential to be a curative treatment.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.About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, ...Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile. Objectives and methods: Randomized, double-blind, placebo-controlled study to assess the safety,...WebSTATEN ISLAND, N.Y., Dec. 6, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ('Acurx' or the 'Company'), a clinical stage biopharm...WebIbezapolstat (Acurx Pharmaceuticals, LLC) is an oral antibiotic that inhibits the DNA polymerase IIIC (pol IIIC) of C difficile . Ibezapolstat has completed phase 1 and phase 2a (NCT04247542) trials . In its phase 2a trial, 10 patients with CDI were administered ibezapolstat 450 mg twice daily for 10 days. All patients (100%) met the …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 ...Ibezapolstat's anti-virulence effect, namely reduced flagellar movement of the C. diff organism was a positive unexpected finding reflecting the unique mode of action in inhibiting DNA pol IIIC.Ibezapolstat (IBZ) is currently in a phase 2 trial against Clostridioides difficile infection, and inhibits bacterial DNA polymerase IIIC (pol IIIC) by interfering with addition of guanine (G) to...Feb 17, 2022 · Ibezapolstat and Vancomycin Head-to-Head: Phase 2b. The new trial is a double-blind, randomized 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 a recurrence of CDI. Apr 19, 2023 · 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 ... Investigational antibiotic ibezapolstat is reported to be the first antibiotic candidate intended to work by blocking the Pol IIIC enzyme in C difficile. This therapy is a first-in-class of a new class of Pol IIIC inhibitors in phase 2 trials with this unique mechanism of action.Dec 1, 2020 · Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period. Ibezapolstat achieved high stool concentrations and plasma concentrations that did not exceed 1 ug/mL. Favorable changes to the microbiome were observed, most notably C. difficile eradication by day 3 and an increased proportion of healthy microbiota, including Clostridiales order taxa known to metabolize primary bile acids to secondary bile ...This drug entry is a stub and has not been fully annotated. It is scheduled to be annotated soon. Generic Name. Ibezapolstat. DrugBank Accession Number. DB16189. Background. Ibezapolstat is under investigation in clinical trial NCT04247542 (ACX-362E Ibezapolstat for Oral Treatment of Clostridioides Difficile Infection).Ibezapolstat (formerly named ACX-362E) is our lead antibiotic candidate. Ibezapolstat is a first-in-class of a new class of Pol IIIC inhibitors which is in ...Nov 19, 2020 · Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial ... Ibezapolstat colonic concentrations averaged 400 ug/g stool at day 3 and greater than 1,000 ug/g by day 10 of dosing. Six of the seven available baseline stool samples3 May 2023 ... Key Clostridium difficile Infections Pipeline Therapies: SER 109, Ibezapolstat, ADS 024, Ridinilazole, RBX7455, Full Spectrum Microbiota ...Mar 16, 2023 · About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non ... 19 Nov 2023 ... ... ibezapolstat, for the treatment of C difficile Infection (CDI). Specifically, in 26 ibezapolstat-treated patients in phases 2a and 2b, the ...Ibezapolstat is a novel DNA polymerase IIIC inhibitor with in vitro activity against C. difficile. Objectives and methods: Randomized, double-blind, placebo-controlled study to assess the safety ...Ibezapolstat designed as a small-molecule DNA Pol IIIC inhibitor based upon competitive inhibition of dGTP. Preclinical development strongly supported continued development into phase I/II clinical trials. To summarize data from the ongoing ibezapolstat clinical development program. Pre-clinical development . OBJECTIVES. Primary: To determine …WebSTATEN ISLAND, N.Y., Dec. 6, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ('Acurx' or the 'Company'), a clinical stage biopharm...Web- Ibezapolstat, is the first of a new class of antibiotics with a novel mechanism of action, a DNA polymerase IIIC inhibitor, to enter clinical efficacy trials - 10 of 10 patients (100%) enrolled in a Ph2A trial met the study's primary and secondary efficacy endpoints of Clinical Cure at end of treatment and Sustained Clinical Cure of no ...Ibezapolstat was well tolerated with 1 adverse event (nausea) probably related to drug. Ibezapolstat systemic exposure was minimal with no plasma level reaching 1 ug/mL any time during therapy. Ibezapolstat colonic concentrations averaged 400 ug/g stool at day 3 and greater than 1,000 ug/g by day 10 of dosing.Ibezapolstat is FDA QIDP and Fast Track Designated for priority review. Robert J. DeLuccia, Executive Chairman of Acurx, stated, "With the excellent clinical results and very good safety and ...Mar 16, 2023 · About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a double-blind, randomized, active-controlled, non ... ibezapolstat Acurx Pharmaceuticals Clostridium difficile infections Phase II (DNA polymerase III inhibitor) White Plains, NY (Fast Track) www.acurxpharma.com IDP-120 gel Bausch Health Americas acne vulgaris Phase III (benzoyl peroxide/tretinoin) Bridgewater, NJ www.bauschhealth.com JNJ-63871860 (ExPEC4V) Janssen Escherichia coli …Nov 2, 2023 · 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 ... Ibezapolstat | C18H20Cl2N6O2 | CID 136022209 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, …On October 2, 2023, Acurx ended enrollment in its Phase 2b clinical trial of ibezapolstat, its lead antibiotic candidate, for the treatment of patients with C. difficile infection, or CDI;WebStool samples were evaluated for microbiome changes and bile acid concentrations. Ibezapolstat 450 mg and vancomycin, but not ibezapolstat 300 mg, showed statistically significant changes in alpha diversity over time compared to that of a placebo. Beta diversity changes confirmed that microbiota were significantly different between study groups. Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial ...Ibezapolstat was well tolerated with a safety signal similar to placebo. Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of stool were observed by Day 2 and for the remainder of the dosing time period.Ibezapolstat is a novel, first-in-class, orally administered antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors in clinical development by Acurx to treat bacterial ...Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1 µg/mL. In the multiday, ascending dose study, ibezapolstat concentrations of 2000 µg/g of ...Ibezapolstat was well tolerated with 1 adverse event (nausea) probably related to drug. Ibezapolstat systemic exposure was minimal with no plasma level reaching 1 ug/mL any time during therapy. Ibezapolstat colonic concentrations averaged 400 ug/g stool at day 3 and greater than 1,000 ug/g by day 10 of dosing. ibezapolstat for the oral treatment for patients with CDI. FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need. Ibezapolstat is a novel, first-in-class, orally3 Aug 2020 ... Ibezapolstat has patent protection through 2039. ACX-375C, chemically related to ibezapolstat, is nearing IND (investigational new drug). (3) ...Ibezapolstat achieved high stool concentrations and plasma concentrations that did not exceed 1 ug/mL. Favorable changes to the microbiome were observed, most notably C. difficile eradication by day 3 and an increased proportion of healthy microbiota, including Clostridiales order taxa known to metabolize primary bile acids to secondary bile ...15 Dec 2020 ... Ibezapolstat is under investigation in clinical trial NCT04247542 (ACX-362E Ibezapolstat for Oral Treatment of Clostridioides Difficile ...Ibezapolstat (Acurx Pharmaceuticals, LLC) is an oral antibiotic that inhibits the DNA polymerase IIIC (pol IIIC) of C difficile . Ibezapolstat has completed phase 1 and phase 2a (NCT04247542) trials . In its phase 2a trial, 10 patients with CDI were administered ibezapolstat 450 mg twice daily for 10 days. All patients (100%) met the …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 ...Ibezapolstat (ACX-362E) is the first DNA polymerase IIIC inhibitor undergoing clinical development for the oral treatment of Clostridioides difficile infection (CDI). In this study, the in vitro activity of ibezapolstat was evaluated against a panel of 104 isolates of C. difficile, including those with characterized ribotypes (e.g. 027 and 078) and those producing …WebAbout the Ibezapolstat Phase 2 Clinical TrialThe completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, ...WebIbezapolstat has completed a phase 1 study in the United States [80]. The randomized, double-blind, placebo-controlled clinical trial involved 62 healthy adults and was divided into three parts. The first consisted of oral administration of a single ascending dose of ibezapolstat at doses of 150, 300, 600 and 900 mg.. Near intelligence