Colistin

Basilea awarded CARB-X grant to develop recently acquired novel class of antibiotics

Retrieved on: 
Tuesday, April 9, 2024
Colistin, Beta-lactam, Education, Development, Partnership, Patient, HHS, Gram-negative bacteria, Escherichia coli, World Health Organization, Infection, USD, Administration, Antibiotic, BMBF, Pharmaceutical industry

The grant award is to support initial preclinical activities on the antibiotics program recently acquired from Spexis.

Key Points: 
  • The grant award is to support initial preclinical activities on the antibiotics program recently acquired from Spexis.
  • Basilea could receive additional funding from CARB-X, to continue preclinical and early clinical development of the antibiotics program, if the project achieves certain milestones.
  • The program comprises antibiotics targeting LptA, which is part of the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria.
  • The molecules belong to one of the very few novel classes of antibiotics in development.

Basilea announces acquisition of preclinical antibiotics program from Spexis

Retrieved on: 
Monday, January 15, 2024
Escherichia coli, World Health Organization, Patient, Gram-negative bacteria, Colistin, Partnership, Beta-lactam, Infection, Transmembrane protein, Bacteria, Klebsiella, Intellectual property, CHF, Lipopolysaccharide, Klebsiella pneumoniae, Vaccine

We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”

Key Points: 
  • We are excited by the addition of this new program to our growing pipeline and to continue the development of this targeted antibiotics class, which has the potential to address an unmet medical need in the treatment of severe bacterial infections in the hospital.”
    The antibiotics were developed within Spexis’ Outer Membrane Protein Targeting Antibiotics (OMPTA) program and selectively disrupt the lipopolysaccharide transport bridge, an essential structure in Gram-negative bacteria.
  • This results in a loss of the integrity of the outer cell membrane, intracellular accumulation of lipopolysaccharides and killing of the bacteria.
  • The program was funded in part by CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator).2 This underscores the potential of this novel class of antibiotics.
  • In addition, Basilea assumes the rights and obligations of Spexis, including potential low single-digit percentage royalties on sales, under licensing agreements.

BiomX Announces Positive Topline Results from Part 2 of the Phase 1b/2a Trial Evaluating BX004 for Treatment of Chronic Pulmonary Infections in Patients with Cystic Fibrosis

Retrieved on: 
Wednesday, November 29, 2023
Patient, Colistin, Culture, Infection, Division, Șaeș, Tobramycin, Aztreonam, Lung, Cystic fibrosis, FEV1, Pediatrics, Therapy, Pseudomonas aeruginosa, University, Phage therapy, Part, Safety, NESS, KOL, Pharmaceutical industry

“These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.

Key Points: 
  • “These study results are highly encouraging especially given the short treatment duration of 10 days with BX004,” said Jonathan Solomon, Chief Executive Officer of BiomX.
  • Patients were on the same inhaled antibiotic (tobramycin, aztreonam, or colistin) from Day 1-10 (treatment period) and through Day 28 of the study.
  • BX004 vs. placebo showed a positive clinical effect in a predefined subgroup of patients with reduced baseline lung function (FEV1
  • BiomX management will host a conference call and webcast today at 9:00 am ET to review the results of Part 2 of the Phase 1b/2a trial results.

XACDURO®, The First and Only Antibiotic Developed to Target Acinetobacter, Now Available to Treat Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP) in Adults

Retrieved on: 
Monday, September 18, 2023
Biotechnology, Infectious Diseases, Hospitals, Health, Pharmaceutical, Anaphylaxis, Infection, Colistin, Acinetobacter, Drug resistance, Incidence, Death, Nursing, VABP, Hospital, MD, Patient, Sulbactam, Carbapenem, Disease, Mortality, Nursing care plan, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry

The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.

Key Points: 
  • The Acinetobacter pathogen has become resistant to most antibiotics used to treat HABP and VABP including carbapenems and third generation cephalosporins.
  • This has caused Acinetobacter to become increasingly difficult to treat with no clear standard of care antibiotic regimen for these resistant infections.
  • “Every minute matters when managing critical care patients with life-threatening pneumonia, especially when caused by carbapenem-resistant Acinetobacter baumannii pathogen.
  • Antibiotic-resistant pathogens can complicate treatment strategies and compromise treatment efficacy, often resulting in increased mortality rates for intensive care unit patients,” said Margaret Koziel, MD, Chief Medical Officer, Innoviva.

Recce Pharmaceuticals Announces RECCE® Trademark Registered in Vietnam, Strengthening Global IP Portfolio

Retrieved on: 
Thursday, September 7, 2023
Antibiotic, International Trademark Association, Intellectual property, ASX, Colistin, FSE, IP, Intensive care medicine, World Organization of the Scout Movement, Hospital, Carbapenem, RCE, Pharmaceutical industry

SYDNEY, Australia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to announce it has been issued a trademark registration for RECCE® from the Intellectual Property Office of Vietnam, strengthening the Company’s global intellectual property (IP) portfolio.

Key Points: 
  • SYDNEY, Australia, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to announce it has been issued a trademark registration for RECCE® from the Intellectual Property Office of Vietnam, strengthening the Company’s global intellectual property (IP) portfolio.
  • The International Trademark Registration No.
  • 1289603 has been formally assigned to the International Bureau (World Intellectual Property Organization), classified under Class 5 for antibiotics, antibiotics for human use, and pharmaceutical preparations, namely mixed antibiotic preparations.
  • “We are thrilled to receive this newly awarded trademark in Vietnam, further strengthening Recce’s intellectual property portfolio in the Asia-Pacific region,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.

Spexis announces the publication of promising results for a novel class of macrocyclic, peptidomimetic antibiotics in Science Advances

Retrieved on: 
Saturday, June 10, 2023
Enterobacteriaceae, University of Zurich, XDR, Probability, The BMJ, University, Medical journal, Prevalence, Science Advances, Infection, Colistin, AMR, European Centre for Disease Prevention and Control, USD, Klebsiella pneumoniae, CDC, Death, MDR, MICS, Patient, Manuscript, ECDC, Korea Disease Control and Prevention Agency, Klebsiella, Mortality, WHO, Lancet, Gene, Escherichia coli, World Health Organization, Pharmaceutical industry, Antibiotics, Vaccine, Science, Spexy Beast, Tata LPTA

The manuscript, titled “Peptidomimetic Antibiotics Disrupt the Lipopolysaccharide Transport Bridge of Drug-Resistant Enterobacteriaceae,” is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.adg3683 .

Key Points: 
  • The manuscript, titled “Peptidomimetic Antibiotics Disrupt the Lipopolysaccharide Transport Bridge of Drug-Resistant Enterobacteriaceae,” is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.adg3683 .
  • In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, leading to over 35,000 deaths and an estimated USD 4.6 billion in healthcare costs.
  • Recent discovery of plasmid-mediated transferable colistin resistance genes have shown the ease with which resistance can spread in bacterial populations.
  • No cross-resistance with standard of care antibiotics was observed and the demonstrated Enterobacteriaceae-specificity versus broad-spectrum activity supports continued development for this class of antibiotics for the potential management and treatment of antimicrobial resistant pathogens.

Spexis announces the publication of promising results for a novel class of macrocyclic, peptidomimetic antibiotics in Science Advances demonstrating potent in vitro and in vivo antimicrobial activity against MDR and XDR Enterobacteriaceae, including carba

Retrieved on: 
Wednesday, June 7, 2023
Enterobacteriaceae, University of Zurich, XDR, Probability, The BMJ, University, Medical journal, Prevalence, Science Advances, Infection, Colistin, AMR, European Centre for Disease Prevention and Control, USD, Klebsiella pneumoniae, CDC, Death, MDR, MICS, Patient, Manuscript, ECDC, Korea Disease Control and Prevention Agency, Klebsiella, Mortality, WHO, Lancet, Gene, Escherichia coli, World Health Organization, Pharmaceutical industry, Vaccine, Antibiotics, Science, Spexy Beast, Tata LPTA

The manuscript, titled “Peptidomimetic Antibiotics Disrupt the Lipopolysaccharide Transport Bridge of Drug-Resistant Enterobacteriaceae,” is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.adg3683 .

Key Points: 
  • The manuscript, titled “Peptidomimetic Antibiotics Disrupt the Lipopolysaccharide Transport Bridge of Drug-Resistant Enterobacteriaceae,” is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.adg3683 .
  • Antimicrobial resistance (AMR) has emerged as a significant threat for both patients and healthcare systems.
  • In the United States, more than 2.8 million antimicrobial-resistant infections occur each year, leading to over 35,000 deaths and an estimated USD 4.6 billion in healthcare costs.
  • The compounds showed potent in vivo efficacy, especially in lung infection models as well as a promising in vitro and in vivo safety profile.

Innoviva Specialty Therapeutics Announces FDA Approval for XACDURO® (sulbactam for injection; durlobactam for injection), Co-packaged for Intravenous Use

Retrieved on: 
Tuesday, May 23, 2023
Biotechnology, Pharmaceutical, Managed Care, Health, FDA, Infectious Diseases, Hospitals, Clinical Trials, Priority review, Ventilator-associated pneumonia, D.C, QIDP, Public, Infection, Georgetown University School of Medicine, New Drug Application, NDA, Colistin, MBA, Acinetobacter, Patient, Physician, Sulbactam, Disease, Fungal infection, Mortality, Nursing care plan, Therapy, MPH, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Safety, Pharmaceutical industry, MD

Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.

Key Points: 
  • Innoviva Specialty Therapeutics is focused on delivering innovative therapies in critical care and infectious disease.
  • “XACDURO is the first pathogen-targeted therapy approved to treat hospital-acquired and ventilator-associated pneumonias caused by Acinetobacter.
  • The FDA approval of XACDURO marks an important milestone in our aim to deliver differentiated therapies to critically ill patients who have limited treatment options,” said David Altarac, MD, Chief Medical Officer, Innoviva Specialty Therapeutics.
  • “Acinetobacter poses a significant danger to hospitalized patients, who are generally very ill and particularly susceptible to infections.

FDA Approves New Treatment for Pneumonia Caused by Certain Difficult-to-Treat Bacteria

Retrieved on: 
Tuesday, May 23, 2023
Hypersensitivity, Infection, Priority review, Center for Drug Evaluation and Research, Enzyme, Colistin, Imipenem/cilastatin, History, VABP, Patient, Division, Sulbactam, Bronchopneumonia, Bacteria, Mortality, Research, Health, FDA, Therapy, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pneumonia, Food, World Health Organization, Vaccine, Pharmaceutical industry

"Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."

Key Points: 
  • "Today's approval helps address a high unmet medical need by providing an additional treatment option for some of the sickest patients in our nation's hospitals."
  • Acinetobacter baumannii-calcoaceticus complex (henceforth referred to as A. baumannii) includes four species of bacteria in the Acinetobacter family.
  • These bacteria can cause infections in various parts of the body, occurring most frequently in healthcare settings and predominantly causing pneumonia.
  • A. baumannii can become highly resistant to multiple antibacterial drugs and current treatment options for drug-resistant A. baumannii are limited.

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.