Colistin

Results from Pivotal Phase 3 ATTACK Trial of Investigational Sulbactam-Durlobactam for Treatment of Serious Infections Caused by Acinetobacter Published in The Lancet Infectious Diseases

Retrieved on: 
Thursday, May 11, 2023
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Infectious Diseases, Clinical Trials, Priority review, Nephrotoxicity, Safety, Infection, Antimicrobial spectrum, New Drug Application, NDA, World Health Organization, Colistin, Acinetobacter, Gram-negative bacteria, Centers for Disease Control and Prevention, CDC, Acinetobacter baumannii, The Lancet, Aminoglycoside, Incidence, Death, Rutgers University, Cephalosporin, Robert Wood Johnson Medical School, Patient, Chronic kidney disease, Penicillin, Division, Carbapenem, Disease, PDUFA, Mortality, Nursing care plan, WHO, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Gene, MPH, Food, Pharmaceutical industry, Vaccine, MD

The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.

Key Points: 
  • The study – Efficacy and Safety of Sulbactam-Durlobactam vs. Colistin for the Treatment of Patients with Serious Infections due to Acinetobacter Baumannii-Calcoaceticus Complex: a multicentre, randomised, active-controlled, Phase 3, non-inferiority clinical trial (ATTACK) – was first published online on May 11.
  • The Phase 3 trial evaluated the safety and efficacy of sulbactam-durlobactam versus colistin in patients with infections caused by Acinetobacter.
  • In the trial, sulbactam-durlobactam demonstrated statistical non-inferiority versus colistin for the primary endpoint of 28-day all-cause mortality in patients with carbapenem-resistant Acinetobacter infections and a significant difference in clinical cure rates.
  • The sulbactam-durlobactam NDA has a Prescription Drug User Fee Act (PDUFA) target action date of May 29, 2023.

Provectus Biopharmaceuticals Announces Publication of Activity of Pharmaceutical-Grade Rose Bengal Sodium (RBS) Against Colistin-Resistant Gram-Negative Bacteria

Retrieved on: 
Thursday, April 20, 2023
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Colistin is used as a last-resort treatment for infections when other drugs fail.

Key Points: 
  • Colistin is used as a last-resort treatment for infections when other drugs fail.
  • The World Health Organization (WHO) classifies colistin as “highest priority critically important for human health.”1
    The article, entitled “Antibacterial effect of rose bengal against colistin-resistant gram negative bacteria,” may be accessed at: https://www.nature.com/articles/s41429-023-00622-1 (subscription required).
  • Dr. Kurosu and his colleagues showed that a formulation of Provectus’ pharmaceutical-grade, high-purity, RBS drug substance (abbreviated as “HP-RBf” in the article):
    Effectively inhibited the growth of colistin-resistant G- bacteria, and
    Possesses a rapid-killing feature for colistin-resistant G- bacteria.
  • Provectus has now demonstrated this molecular characteristic of our rose bengal sodium preclinically and/or clinically in oncology, dermatology, and infectious diseases, establishing once again the veracity of Provectus’ small molecule halogenated xanthene medical science.”

Sulbactam-Durlobactam Unanimously Recommended for Approval by FDA Advisory Committee

Retrieved on: 
Monday, April 17, 2023
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The FDA will take the Committee’s recommendation into consideration when it makes a final determination.

Key Points: 
  • The FDA will take the Committee’s recommendation into consideration when it makes a final determination.
  • Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortality1 and long, expensive hospital stays.
  • Globally, Acinetobacter baumannii was among the top six leading pathogens for deaths associated with resistance in 20193.
  • Carbpenem-resistant Acinetobacter is considered a Priority 1 pathogen by the World Health Organization (WHO)4.

Innoviva Announces FDA Advisory Committee Meeting to Review Sulbactam-Durlobactam (SUL-DUR), an Investigational Targeted Antibiotic

Retrieved on: 
Monday, March 13, 2023
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Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).

Key Points: 
  • Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).
  • SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
  • Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortalityi.
  • The Committee will review data from studies involving SUL-DUR, including data from the landmark Phase 3 trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter.

Zai Lab Announces NDA Acceptance of Sulbactam-Durlobactam (SUL-DUR) for Infections Caused by Acinetobacter baumannii in China by the NMPA

Retrieved on: 
Wednesday, February 22, 2023
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“We are pleased to obtain the NMPA’s acceptance of our submission for the registration of SUL-DUR, an intravenous (IV) antibiotic combination for patients with Acinetobacter infections including multidrug and carbapenem-resistant strains.

Key Points: 
  • “We are pleased to obtain the NMPA’s acceptance of our submission for the registration of SUL-DUR, an intravenous (IV) antibiotic combination for patients with Acinetobacter infections including multidrug and carbapenem-resistant strains.
  • SUL-DUR is poised to address a clear unmet medical need as patients face very limited treatment options with this pathogen, which causes serious infections with high mortality.
  • “The ATTACK trial has shown SUL-DUR treated patients have lower mortality and less renal toxicity compared to standard-of-care colistin therapy.
  • Zai Lab participated in the global ATTACK study by enrolling trial patients in China.

Innoviva Announces FDA Acceptance and Priority Review of New Drug Application for Sulbactam-Durlobactam (SUL-DUR)

Retrieved on: 
Wednesday, November 30, 2022
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The Agency is currently planning to hold an advisory committee meeting to discuss this application.

Key Points: 
  • The Agency is currently planning to hold an advisory committee meeting to discuss this application.
  • SUL-DUR also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.
  • Carbapenem-resistant and multidrug-resistant Acinetobacter infections are an urgent and emergent threat due to increasing rates of resistance and few viable treatment options.
  • Our focused and dedicated team looks forward to continuing to work with the FDA throughout the priority review process.

Entasis Therapeutics, a Wholly Owned Subsidiary of Innoviva, Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at IDWEEK 2022

Retrieved on: 
Wednesday, October 19, 2022
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Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.

Key Points: 
  • Results showed that ABC isolates from patients in ATTACK were highly antibiotic-resistant, but >95% susceptible to SUL-DUR.
  • This study evaluated PPK in 373 subjects, including 110 patients who received SUL-DUR and underwent PK sampling in the pivotal Phase 3 ATTACK trial.
  • In addition to the oral presentations, three poster presentations highlighted additional SUL-DUR and ATTACK trial details and results.
  • All Entasis IDWeek 2022 presentations will be made available on the Entasis website https://www.entasistx.com/our-science/presentations-by-event.

Everest Medicines Announces Regulatory Update and Strategic Partnership for Xerava™ in Taiwan

Retrieved on: 
Thursday, August 11, 2022
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SHANGHAI, Aug. 10, 2022 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI).

Key Points: 
  • In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan.
  • It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing.
  • Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.
  • Everest Medicines has built a portfolio of elevenpotentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development.

Entasis Therapeutics Presents Data Highlights from Phase 3 ATTACK Trial at 2022 American Thoracic Society Annual Conference

Retrieved on: 
Tuesday, May 17, 2022
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WALTHAM, Mass., May 17, 2022 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (Nasdaq: ETTX), a late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that the company presented data highlights from its pivotal Phase 3 ATTACK trial at the American Thoracic Society (ATS) annual conference, held this week from May 16-18, 2022, in San Francisco, California.

Key Points: 
  • WALTHAM, Mass., May 17, 2022 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (Nasdaq: ETTX), a late-stage clinical biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced that the company presented data highlights from its pivotal Phase 3 ATTACK trial at the American Thoracic Society (ATS) annual conference, held this week from May 16-18, 2022, in San Francisco, California.
  • The poster presentation P628 Sulbactam-Durlobactam (SUL-DUR) Treatment Is Associated with Lower Mortality from Index Acinetobacter Infections in the Attack Phase 3 Registrational Trial presented key data from the landmark ATTACK trial.
  • Sulbactam-durlobactam is an investigational drug in development for the treatment of infections caused by Acinetobacter baumannii including carbapenem-resistant and multi-drug resistant strains.
  • Key findings in this presentation include:
    There was a notable divergence in all-cause mortality between days 6-14 with higher rates of mortality in the colistin treatment arm.

Entasis Therapeutics Presents Efficacy and Safety Data from Landmark Phase 3 ATTACK Trial at ECCMID 2022 Conference

Retrieved on: 
Tuesday, April 26, 2022
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In Entasiss first oral presentation, Dr. Alita Miller, PhD, Vice President, Microbiology discussed the Characterization of Acinetobacter baumannii-calcoaceticus complex (ABC) pathogens isolated at baseline from patients enrolled in the ATTACK Phase 3 trial.

Key Points: 
  • In Entasiss first oral presentation, Dr. Alita Miller, PhD, Vice President, Microbiology discussed the Characterization of Acinetobacter baumannii-calcoaceticus complex (ABC) pathogens isolated at baseline from patients enrolled in the ATTACK Phase 3 trial.
  • In contrast, only 4.6% of isolates had sulbactam-durlobactam (SUL-DUR) MICs >4 mg/L (above the preliminary breakpoint).
  • The ATTACK trial was conducted to evaluate the efficacy and safety of SUL-DUR versus colistin, both in combination with imipenem/cilastatin, for patients with ABC infections, including carbapenem-resistant and multidrug-resistant strains.
  • Notably, only 45% of these isolates were susceptible to imipenem alone while 73% were imipenem-susceptible in the presence of SUL-DUR.