Fidaxomicin

Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results at ESCMID Global 2024 Scientific Conference

Retrieved on: 
Thursday, May 2, 2024
Infection, Clostridioides difficile infection, Congress, University, University of Houston, Vancomycin, Professor, Poster, Recurrence, IIIC, Disease, DNA, Patient, Treatment, Microbiology, Doctor of Pharmacy, Diarrhea, CDI, Fidaxomicin, Clostridioides difficile, Houston Community College, Pharmaceutical industry

The presentation included additional analyses of clinical and microbiological data from the Phase 2b Segment of the trial.

Key Points: 
  • The presentation included additional analyses of clinical and microbiological data from the Phase 2b Segment of the trial.
  • Commenting on his presentation, Dr. Garey stated: "This randomized, active-controlled study showed ibezapolstat was comparable to vancomycin in achieving clinical cure in patients with mild-to-moderate CDI.
  • The presentation and poster are available on the Acurx Pharmaceuticals website following their respective presentations at the conference.
  • www.acurxpharma.com
    The complete Phase 2 results are being prepared for submission to a prominent scientific journal.

Acurx Announces Ibezapolstat Scientific Poster and Update on its Pol IIIC Pipeline Presented at ECCMID 2023 Scientific Conference

Retrieved on: 
Wednesday, April 19, 2023
ISLAND, VRE, Clostridioides difficile infection, DNA, DNA-binding protein, University, IV, Flagellum, Public, IIIC, MRSA, Infection, Genetically modified bacteria, Houston Community College, Solubility, DRSP, Movement, Congress, Professor, ECCMID, Vancomycin, European, Metronidazole, University of Houston, Fidaxomicin, Susceptibility, Poster, Principal, Pharmacology, Recurrence, Virulence, Safety, Microbiology, Vaccine, Pharmacy

C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.

Key Points: 
  • C. difficile strains with reduced susceptibility to metronidazole, vancomycin, or fidaxomicin were susceptible to ibezapolstat, confirming its unique mechanism of action.
  • To study anti-virulence effect, our group investigated an under-studied virulence property of C difficile, namely, flagellar movement of the organism.
  • All of these positive and unexpected findings reflect the unique mode of action in inhibiting DNA pol IIIC and support the continued development of ibezapolstat to treat C. difficile infection."
  • The poster and presentation are available on the Company's website www.acurxpharma.com.

Tillotts Pharma AG announces that DIFICLIRTM (fidaxomicin) is recommended for the treatment of Clostridioides difficile infection (CDI) by ESCMID

Retrieved on: 
Wednesday, December 8, 2021
Health, Infectious Diseases, Clinical Trials, Research, Pharmaceutical, Science, Medical microbiology, Disease, CDI, European Society of Clinical Microbiology and Infectious Diseases, Infectious Diseases Society of America, News, Risk factor, ESCMID, Recurrence, Goldenberg, Dis, Clostridioides difficile infection, Microbiota, Infection, PMID, Acquisition, Plasma protein binding, Clostridioides, Meta-analysis, ECDC, IDSA, Patient, IBD, Consultant, Mortality, OTC, Human, Tesco international operations, Clostridium difficile, Systematic review, Vancomycin, European Centre for Disease Prevention and Control, Lancet, University, Tablet, Guideline, Society, Wes Tillott, Fidaxomicin, CDAD, Health care, MD, Adult, RNA, Clinical trial, Trial of the century, Vaccine, Pharmaceutical industry, DIFICLIRTM, Tillotts, Zeria, DIFICLIRTM, TILLOTTS, ZERIA

Despite the endemic nature of C. difficile in many healthcare settings, sustained clinical cure and prevention of recurrence are achievable treatment goals for CDI.

Key Points: 
  • Despite the endemic nature of C. difficile in many healthcare settings, sustained clinical cure and prevention of recurrence are achievable treatment goals for CDI.
  • European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults.
  • Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial.
  • Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with over 300 employees in Switzerland and abroad.

Acurx Pharmaceuticals to Discuss 2021 Second Quarter Financial Results on August 17, 2021 Conference Call and Provide Business Update

Retrieved on: 
Wednesday, July 28, 2021
Health, Medical specialties, Antibiotic-resistant bacteria, Clostridiaceae, Clostridioides difficile, Gram-positive bacteria, Antibiotic, Fidaxomicin

It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

Key Points: 
  • It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.
  • The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.
  • Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections.
  • To learn more about Acurx Pharmaceuticals and its product pipeline, please visit www.acurxpharma.com .

FDA Approves Merck’s DIFICID® (fidaxomicin) to Treat Clostridioides difficile in Children Aged Six Months and Older

Retrieved on: 
Monday, January 27, 2020
Biotechnology, Pharmaceutical, Health, Clinical trials, Medicine, Medical specialties, Infectious diseases, RTT, Feces, Antibiotic-resistant bacteria, Clostridiaceae, Clostridioides difficile, Gram-positive bacteria, Fidaxomicin, Diarrhea, Antibiotic, Clostridioides, Merck

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridioides difficile (C. difficile).

Key Points: 
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of DIFICID and other antibacterial drugs, DIFICID should be used only to treat infections that are proven or strongly suspected to be caused by Clostridioides difficile (C. difficile).
  • DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
  • C. difficile is an important cause of health care- and community-associated diarrheal illness in children, and sustained cure is difficult to achieve in some patients.
  • I am very excited to have a new C. difficile infection treatment option for my pediatric patients.

FDA Accepts Two Applications for Merck’s DIFICID® (fidaxomicin) to Treat Children Aged Six Months Up to 18 years with Clostridium difficile Infections

Retrieved on: 
Wednesday, October 2, 2019
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Other Science, Research, Infectious diseases, General Health, Science, Medical specialties, Medicine, Infectious diseases, RTT, Fidaxomicin, Merck, Clostridioides difficile infection, Clostridioides difficile, Antibiotic, Prescription Drug User Fee Act, Diarrhea, DIFICID (fidaxomicin), Clostridium, Merck

The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020.

Key Points: 
  • The Prescription Drug User Fee Act (PDUFA), or target action date for both applications, is set for Jan. 24, 2020.
  • DIFICID is a macrolide antibacterial medicine indicated in adults (18 years of age or older) for treatment of Clostridium difficile-associated diarrhea (CDAD).
  • DIFICID is contraindicated in patients who have known hypersensitivity to fidaxomicin or any other ingredient in DIFICID.
  • DIFICID is not effective for treatment of other types of infections due to minimal systemic absorption of fidaxomicin.

ANI Pharmaceuticals Announces Approval of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5ml

Retrieved on: 
Thursday, June 20, 2019
RTT, Medical specialties, Medicine, Infectious diseases, Eli Lilly and Company, Antibiotic-resistant bacteria, Total synthesis, Vancomycin, Clostridioides difficile, Enterocolitis, Fidaxomicin, Glycopeptide antibiotic

BAUDETTE, Minn., June 20, 2019 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received FDA approval of its Prior Approval Supplement for Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml, indicated for the treatment of various infections.

Key Points: 
  • BAUDETTE, Minn., June 20, 2019 /PRNewswire/ -- ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received FDA approval of its Prior Approval Supplement for Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml, indicated for the treatment of various infections.
  • ANI acquired the ANDA for Vancomycin for Oral Solution in 2014 in an acquisition that included the NDA for Vancocin 125 mg and 250 mg capsules and approved ANDAs for Vancomycin Hydrochloride Injection 500 mg, 1 gm and 10 gm.
  • Vancomycin Hydrochloride for Oral Solution is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis caused by C. difficile.
  • ANI Pharmaceuticals, Inc. (the "Company" or "ANI") is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.

Clostridium Difficile-Associated Diarrhea Clinical Trial Pipeline Highlights 2019 - Forecast to 2024 by Clinical Stage, Drug Mechanism Classes, & Companies - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 13, 2019
Professional services, Consulting, Bacteria, Medical specialties, Medicine, Clostridiaceae, Gram-positive bacteria, RTT, Sanitation, Clostridium, Clostridioides difficile, Diarrhea, Fidaxomicin, Clostridium difficile toxin A

The "Global Clostridium Difficile-Associated Diarrhea Clinical Trial Pipeline Highlights - 2019" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Clostridium Difficile-Associated Diarrhea Clinical Trial Pipeline Highlights - 2019" report has been added to ResearchAndMarkets.com's offering.
  • Clostridium Difficile-Associated Diarrhea Pipeline Highlights - 2019, provides most up-to-date information on key pipeline products in the global Clostridium Difficile-Associated Diarrhea market.
  • It covers emerging therapies for Clostridium Difficile-Associated Diarrhea in active clinical development stages including early and late stage clinical trials.
  • The report provides Clostridium Difficile-Associated Diarrhea pipeline products by clinical trial stages including both early and late stage development - phase 3 clinical trials, phase 2 clinical trials, phase 1 clinical trials, preclinical research, and discovery stage.

Finch Therapeutics’ Investigational Drug CP101 Granted Breakthrough Therapy Designation from FDA for Recurrent C. Difficile Infection

Retrieved on: 
Friday, February 8, 2019
Health, Biotechnology, Clinical trials, Pharmaceutical, FDA, Bacteria, Infectious diseases, Medical specialties, Diarrhea, Clostridiaceae, Gram-positive bacteria, Antibiotic-resistant bacteria, Clostridioides difficile, C. Diff, Fidaxomicin, Fecal microbiota transplant

Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational drug CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection.

Key Points: 
  • Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to investigational drug CP101 for the treatment of patients with recurrent Clostridium difficile (C. difficile) infection.
  • Finchs lead therapeutic candidate CP101 is designed to prevent recurrent C. difficile, a bacterial infection affecting over 500,000 patients each year and leading to an estimated 29,000 annual deaths.
  • We are thrilled that CP101 has been designated as a Breakthrough Therapy for recurrent C. difficile, said Mark Smith, CEO of Finch.
  • Finch is actively enrolling patients with recurrent C. difficile in PRISM3, a randomized, placebo-controlled Phase II clinical study to assess the safety and efficacy of CP101.

Clostridium Difficile Infections (Clostridium Difficile Associated Disease) - Pipeline Insight, 2019 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, January 22, 2019
Health, Biotechnology, Infectious diseases, Pharmaceutical, Bacteria, Clostridiaceae, Microorganisms, Gram-positive bacteria, Infectious diseases, Clostridioides difficile, Clostridium, Colitis-X, Fidaxomicin

The "Clostridium Difficile Infections (Clostridium Difficile Associated Disease) - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Clostridium Difficile Infections (Clostridium Difficile Associated Disease) - Pipeline Insight, 2019" drug pipelines has been added to ResearchAndMarkets.com's offering.
  • This report offers comprehensive Insight of the pipeline (under development) therapeutics scenario and growth prospects across Clostridium Difficile Infections (Clostridium Difficile Associated Disease) development.
  • The report provides detailed coverage of the pipeline landscape for this mechanism of action, equipped with data from multiple sources with complete pipeline analysis by developmental stage, associated indications, route of administration and molecule type.
  • The report assesses the active Clostridium Difficile Infections (Clostridium Difficile Associated Disease) pipeline products by developmental stage, product type, molecule type, and administration route.