Ibezapolstat.

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'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 ...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 ...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 ...

Sep 30, 2022 · Plasma 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. Worldwide, approximately 257 million people live with chronic hepatitis B virus (HBV) infection, defined as the persistence of detectable hepatitis B surface antigen (HBsAg) for more than 6 months. 1-4 Chronic HBV infection may be asymptomatic for many years; however, chronic infection may progress over time to trigger debilitating conditions …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 ...

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.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 ...

The cure rates for ibezapolstat are underscored by the scientific facts, including getting over 100 X the concentration of ibezapolstat into the site of the infection (the colon) than is needed to ...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 ...Acurx's lead agent ibezapolstat has cleared phase 1 and is well into phase 2a without such safety issues. The company outright owns the intellectual property on which its agents are based and is not merely a licensee. Acurx purchased the technology from GLSynthesis, Inc., in February 2008. At that time, that firm was owned and controlled by …WebApr 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 ...

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 …Web

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 ...

A: Our ibezapolstat is new to treating patients with C difficile infection. We think it can emerge as a candidate for front-line therapy for several reasons, including its currently holding a 100% cure rate based on existing data in Ph2a and its cure rate is durable with no reinfections.difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients. were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made …WebHe added: "Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the …ibezapolstat (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 DRUGWe would like to show you a description here but the site won’t allow us.Ibezapolstat (previously known as ACX 362E) is an orally administered DNA polymerase IIIC (pol IIIC) inhibitor, being developed by Acurx Pharmaceuticals, under Ibezapolstat - …

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 ...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 ...Acurx has completed its Phase 2b clinical trial of ibezapolstat compared to vancomycin, a standard of care to treat C. difficile infection or CDI. The Phase 2b clinical trial was a …The 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 ...WebIbezapolstat 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 ...

STATEN ISLAND, N.Y., Aug. 15, 2022 /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 …Web

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 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.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 ...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.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).Ibezapolstat Shows Best In Class Potential. Indeed, ACXP’s ibezapolstat is already attracting attention. The good kind. In fact, the FDA granted QIDP and Fast Track Designations that provide priority review. Thus, with those pieces in place, positive results from its Phase 2b trial could set the stage for an enormous back half of 2022. Frankly, if …WebCompany 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 …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.

Acurx Announces Publication of Positive Phase 2a Clinical Trial Results of Ibezapolstat for CDI in Clinical Infectious Diseases. Clinical results of 10 of 10 patients …

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;Web

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). About the Ibezapolstat Phase 2 Clinical TrialThe completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, ...WebNov 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 ... 14 Nov 2023 ... The company can now expedite advancement of ibezapolstat into phase III clinical trials. H.C. Wainwright & Co. analysts noted that even though ...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 Company's 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 ...Apr 19, 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 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 ...

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 …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.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.Instagram:https://instagram. demo trade1921 silver liberty dollar valuedoes webull trade cryptohow to buy ripple from coinbase 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 ...8 Nov 2021 ... Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known ... trading scannerberkshire hathaway b share 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 ... Acurx has completed its Phase 2b clinical trial of ibezapolstat compared to vancomycin, a standard of care to treat C. difficile infection or CDI. The Phase 2b ... workers compensation insurance providers california ibezapolstat against C. difficile isolates with reduced susceptibility toC. difficile-directed antibiotics" has been accepted. Dr. Kevin Garey, Professor and Chair, University of Houston College of Pharmacy and the Principal Investigator for microbiome aspects of our ibezapolstat clinical trial program, will present on our behalf;WebNov 2, 2023 · 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 ... 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 ...