Ibezapolstat.
But ibezapolstat represents the vanguard agent in a class, DNA polymerase IIIc inhibitors, non-toxic versions of which have been sought by the pharma industry for decades. Mammals lack any enzyme similar to DNA polymerase IIIc, and its constitutive necessity in Gram-positive pathogens is well known. The enzyme is an ideal drug target.
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 …Earlier this month, Acurx Pharmaceuticals announced efficacy results from their phase 2 clinical trial of an investigational antibiotic, ibezapolstat, for the treatment of C difficile Infection (CDI). Specifically, in 26 ibezapolstat-treated patients in phases 2a and 2b, the clinical cure rate was 96%, and the investigators reached their objective of assessing …Remember, data supports the potential for ibezapolstat to become the front-line therapy to treat over 500,000 patients who get CDI each year. Of those 500,000, more than 20,000 patients per year die.- 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 ...
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 ... 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, ... 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 ...
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 ...WebIbezapolstat (IBZ; ACX362E) • Ibezapolstat: 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™ (Gram Positive Selective Spectrum) ACX-362
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 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 ...WebAbout 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.NCT04247542: Phase 2 Interventional Active, not recruiting Clostridium Difficile Infection (2020)STATEN ISLAND, N.Y., Dec. 6, 2021 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ('Acurx' or the 'Company'), a clinical stage biopharm...Web
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 ...
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 …Web
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 ...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.6 Nov 2023 ... 11月2日，生物制药公司Acurx Pharmaceuticals对外表示，候选药物Ibezapolstat治疗艰难梭菌感染（CDI）的2期临床试验，取得了积极结果。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 ... 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.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 ... 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 …
Monday, August 14, 2023. 8:00 a.m. ET. 877-790-1503. About the Ibezapolstat Phase 2 Clinical Trial The completed multicenter, open-label single-arm segment (Phase 2a) study is now followed by a ...WebIbezapolstat (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 …WebIbezapolstat (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 now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours ...Ibezapolstat demonstrated an increased proportion of Actinobacteria, including the Bifidobacteriaceae family. Using a linear regression analysis, vancomycin …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. NCATS Inxight Drugs — IBEZAPOLSTAT ... ChemicalWeb
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 …Web
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 ...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. STATEN ISLAND, N.Y., Oct. 4, 2021 /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 that a scientific abstract and poster were presented on September 29 th at the ...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 ...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 …WebIbezapolstat 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 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 PharmacyMethods: 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) or vancomycin (125 mg given four times daily). Stool samples were evaluated for microbiome and functional metagenomics changes using shotgun ...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 ...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 ...
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 ...
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).
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 ...Development Update on Ibezapolstat for the Treatment of Clostridioides difficile infection: Focus on the Microbiome Kevin W. Garey, PharmD, MS, FASHP, FIDSA Professor and Chair Dept of Pharmacy Practice and Translational Research. Ibezapolstat (IBZ; ACX362E) •Ibezapolstat: small-molecule inhibitor of DNA pol IIIC enzyme based upon competitive …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. 24 Nov 2023 ... ... Ibezapolstat drug, a treatment for patients with Clostridioides difficile Infections (CDI). Based on positive data from Phase 2a and Phase ...Ibezapolstat (ACX-362E) is a first-in-class, orally active DNA polymerase IIIC (pol IIIC) inhibitor, with a of 0.325 μM for the DNA pol IIIC from . Ibezapolstat is developed for the research of infection (CDI) MedChemExpress (MCE) has not independently confirmed the accuracy of these methods. They are for reference only.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 ...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 …Sep 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. Kevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member stated: " These results confirm and extend data from the open-label component of the Phase 2 study and …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 ...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: 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)
Poster Presentation and Abstract from ID Week (October 2021) titled “An Open-label Phase 2a study of Ibezapolstat, a Unique Gram-positive Selective Spectrum (GPSS®) Antibiotic, for Patients with Clostridioides difficile Infection.” presented by Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy”.WebIbezapolstat has been granted QIDP (Qualified Infectious Disease Product) status; FDA Fast Track designation granted. ACX375C is QIDP and FDA Fast-Track eligible and is planned to be applied for pre-IND and post-IND, respectively. 6 Sept 2020 ... Ibezapolstat had minimal systemic absorption with the majority of plasma concentrations less than 1μg/mL. In the multiday, ascending dose study, ...Instagram:https://instagram. price target stocksbest trading platform for short sellingai company stocksforex trading algorithm 4 Oct 2022 ... ... (Ibezapolstat) is in progress for treatment of Clostridium difficile (11). These compounds compete with deoxynucleotide triphosphate (dNTP) ... quarter collectorswhy is oil going down In the upcoming 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 125 mg orally ...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 ... where is the kia telluride made 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. 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.