Ibezapolstat.

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 ACXP. Acurx Pharmaceuticals, Inc., a clinical stage biopharmaceutical company, develops antibiotics to treat bacterial infections. The company's lead antibiotic candidate is ibezapolstat, a novel mechanism of action that targets the polymerase IIIC enzyme that has completed Phase IIa clinical trial to treat patients with clostridium difficile infections.Oct 2, 2023 · 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 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 ...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 ...

Ibezapolstat has been shown to inhibit pol IIC from C difficile, making CDI an attractive therapeutic target for the antibiotic. So far, ibezapolstat has shown promise in early research. The company in early November released data from its phase 2a study showing the drug wiped out CDI in all 10 patients studied, and also prevented recurrence ...

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 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.17 Nov 2023 ... Acurx Pharmaceuticals announced efficacy results from the Phase 2 clinical trials for their narrow spectrum antibiotic ibezapolstat for the ...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. Ibezapolstat (ACX-362E) is under development for the treatment of Clostridium difficile Infections. The drug candidate is administered through oral route in the ...

Ibezapolstat has also been demonstrated to have an MIC between 1 and 8 µg/mL and was active against CD in the clinical phase III trial (NCT04247542) [87,88]. The US FDA has also granted QIDP and fast-track status to ibezapolstat [ 87 ].Web

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 ...

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.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 ...ACX-375C Program with GPSS®. Acurx’s second antibiotic program now in lead optimization stage of preclinical development seeks to develop innovative, systemic Gram-positive selective spectrum (GPSS ®) bactericidal antibiotics which target all multi-drug resistant (MDR) and sensitive Gram-positive bacterial pathogens.WebParticularly notable are the data showing that ibezapolstat enhances the population of actinobacteria without promoting proteobacteria overgrowth, suggesting the potential for ibezapolstat to have a “restorative” effect on the microbiome.” About ibezapolstat. Ibezapolstat is a novel, first-in-class, orally administered antibacterial.Nov 2, 2023 · 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. 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, 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, 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 ...Nov 5, 2021 · 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 was followed by a double-blind, randomized, active-controlled, ...While extensive in vitro studies demonstrating the effects of ibezapolstat on the broader gut microbiome are lacking, it has an MIC 90 to C. difficile of 4 μg/mL . In an in vivo hamster model, ibezapolstat had identical survival rates (33%) to vancomycin at 34 days following only 3 days of therapy . However, when the treatment was extended to ...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, ...Apr 11, 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 has previously received FDA Qualified Infectious Disease Product and Fast-Track Designation Management will be available for Q&A on November 14, 2023 earnings call https://www.acurxpharma.com/news-media/press-releases/detail/65/acurx-pharmaceuticals-to-discuss-third-quarter-2023Ibezapolstat has designations for both FDA Qualified Infectious Disease Product and FDA Fast-Track and is the first in class of a new class of antibiotics. If approved, ibezapolstat would be the first new class of …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 …WebIbezapolstat: small-molecule inhibitor of DNA pol IIIC enzyme based upon competitive inhibition of dGTP (guanosine analog) DNA pol IIIC: essential for replication of low G+C content Gram-positive bacteria (Firmicutes) ; Novel mechanism of action GPSS™ (G ram P ositive S elective S pectrum)Ibezapolstat binds to and inhibits DNA pol IIIC from aerobic and low G+C Gram-positive bacteria[1]. Ibezapolstat displays antibacterial activities against broad spectrum of C. difficile pathogens, with an MIC range of 1-8 μ In Vitro Product Data Sheet Inhibitors • Screening Libraries • Proteins Page 1 of 2 www.MedChemExpress.com14 Aug 2023 ... Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may ...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 ...Oct 2, 2023 · 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. 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.6 May 2023 ... Luci: ACX-362E, now named ibezapolstat is now in Ph2b clinical trial in patients with C difficile infection having successfully completed Ph2a ...

19 Apr 2023 ... ... ibezapolstat, et par le Dr Eugenie Basseres, chercheuse scientifique à l'Université de Houston. La Société recrute actuellement des patients ...

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...Web

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 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.In a groundbreaking announcement on November 2, 2023, Acurx Pharmaceuticals unveiled the remarkable results of their Phase 2 clinical trial for ibezapolstat, a potential game-changer in the treatment of C. difficile Infection (CDI).The trial achieved its primary objective of evaluating the efficacy of ibezapolstat by …Ibezapolstat will now move forward to Phase 3 clinical trials. Further data will be provided when available on all of the secondary and exploratory endpoints in the Phase 2b trial, including sustained clinical cure data, extended clinical cure data up to 94 days and impact on the microbiome compared to vancomycin.We anticipate that these ...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.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.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 ...Nov 2, 2023 · In a total of 26 ibezapolstat-treated patients in Phases 2a and 2b, the Clinical Cure rate is 96%; Meets protocol primary objective of assessing the primary efficacy endpoint of the Clinical Cure ... On November 2, 2023, Acurx 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);. Ibezapolstat will now move forward to Phase …WebSep 6, 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 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 ...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 …

Mar 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 ... Apr 11, 2023 · 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 ... 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, orallyAbout 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 ...Instagram:https://instagram. google stock history splithandr reitvenezuela's oil productionmeta options Background: Ibezapolstat is a Gram-positive selective spectrum antibiotic in phase 2 clinical trials for treatment of C. difficile infection. With a. watson.xrecovery unplugged nj Ibezapolstat has been shown to inhibit pol IIC from C difficile, making CDI an attractive therapeutic target for the antibiotic. So far, ibezapolstat has shown promise in early research. The company in early November released data from its phase 2a study showing the drug wiped out CDI in all 10 patients studied, and also prevented recurrence ... crdix Company Overview. Acurx Pharmaceuticals is a publicly held clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. Acurx's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes early stage antibiotic candidates …Feb 4, 2022 · 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 ...