Acinetobacter baumannii

Spero Therapeutics Announces Fourth Quarter and Full Year 2023 Operating Results and Provides a Business Update

Retrieved on: 
Wednesday, March 13, 2024
Gram-negative bacteria, Department of Defence, Urinary tract infection, GSK, Patient, Human services, Quality of life, IND, Tebipenem, Clinical trial, Therapy, Infection, Research, Policy, Treasurer, Carbapenem-resistant enterobacteriaceae, Safety, Pharmacokinetics, Federal, Food, AP, Drug discovery, Disease, Kidney, SPA, Acinetobacter baumannii, MDR, Pyelonephritis, Annual report, FDA, Army, HBR, Government, Unitary state, NTM, Assistant, Fungal infection, Pseudomonas aeruginosa, Hope, National Institutes of Health, ID, Mycobacterium avium complex, Bangladesh Technical Education Board, Administration, Pharmaceutical industry

“2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.

Key Points: 
  • “2023 was a productive year for Spero and we have been focused on execution across our programs,” said Sath Shukla, President, and Chief Executive Officer of Spero.
  • Top-line data from the Phase 2a proof-of-concept clinical trial in treatment-naive and treatment-experienced non-refractory NTM-PD patients is expected in 2H 2024.
  • Spero commenced enrollment in PIVOT-PO, a global, randomized, double-blind, Phase 3 clinical trial of tebipenem HBr in patients with cUTI, including AP in December 2023.
  • Total revenue for the fourth quarter of 2023 was $73.5 million, compared with total revenue of $47.4 million for the fourth quarter of 2022.

Omnix Medical Granted Fast-Track Designation by U.S. FDA for its Next-Generation Anti-Infective OMN6

Retrieved on: 
Tuesday, February 20, 2024
Infection, Acinetobacter baumannii, FDA, Food, ABC, Bronchopneumonia, AMP, Phenotype, Patient, CSO, Gram-negative bacteria, IND, VABP, Pharmaceutical industry

JERUSALEM, Israel, February 20, 2023 -- Omnix Medical, a biopharmaceutical company developing next-generation anti-infectives for the treatment of life-threatening infections, today announced that the Company has received fast-track designation for its novel anti-infective OMN6 from the U.S. Food and Drug Administration (FDA). Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.

Key Points: 
  • Fast track expedited review is designated to investigational drugs that treat a serious or life-threatening condition and fill an unmet medical need.
  • OMN6 is Omnix Medical´s lead compound and a novel, first-in-class antimicrobial peptide (AMP) based on insect host defense peptides.
  • In November 2023, Omnix Medical had been granted an IND for a Phase II trial of OMN6 in patients with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by Acinetobacter baumannii complex (ABC).
  • "We are excited that the U.S. FDA has granted fast-track designation for our lead compound OMN6," said Dr. Moshik Cohen-Kutner, CEO of Omnix Medical.

T2 Biosystems Announces Preliminary Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, February 15, 2024
Human services, International, Candida auris, Sepsis, Acinetobacter baumannii, FDA, Growth, U.S. FDA, CRG, Therapy, Research, Panel

LEXINGTON, Mass., Feb. 15, 2024 (GLOBE NEWSWIRE) --  T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • LEXINGTON, Mass., Feb. 15, 2024 (GLOBE NEWSWIRE) --  T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial and operational results for the fourth quarter and full year ended December 31, 2023.
  • Achieved full year 2023 total revenue of $7.2 million, including sepsis and related product revenue of $6.8 million and research and contribution revenue of $0.4 million.
  • Achieved fourth quarter 2023 total revenue of $1.7 million, comprised entirely of product revenue including record sales of the T2Bacteria Panel in the U.S.
  • Executed contracts for 26 T2Dx® Instruments in 2023, including 19 T2Dx Instruments from outside the U.S. and 7 T2Dx Instruments from the U.S.

T2 Biosystems Receives FDA 510(k) Clearance for the Expanded T2Bacteria Panel

Retrieved on: 
Monday, February 12, 2024
Pseudomonas aeruginosa, Infection, ICU, Escherichia coli, Catheter, Acinetobacter baumannii, FDA, Food, Carbapenem, Bloodstream infections, Risk, Intensive care medicine, Bacteria, World Health Organization, Patient, Septic shock, S. aureus, Mortality

LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.

Key Points: 
  • LEXINGTON, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the expanded T2Bacteria® Panel, adding the capability to detect another bacterial species, Acinetobacter baumannii (A. baumannii), to the expansive panel.
  • “We are thrilled to receive the FDA 510(k) clearance for the expanded T2Bacteria Panel, to include the detection of A. baumannii, as we believe it will lead to increased adoption of our proprietary direct-from-blood platform,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • The FDA-cleared T2Bacteria Panel now detects E. faecium, S. aureus, K. pneumoniae, P. aeruginosa, E. coli, and A. baumannii.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.

New antibiotic zosurabalpin shows promise against drug-resistant bacteria – an expert explains how it works

Retrieved on: 
Friday, January 5, 2024
World, Cell death, Infection, Carbapenem, Roche, Crab, Hospital, Mouse, Human, News, Clinical trial, Cell wall, Acinetobacter baumannii, Animal, System, World Health Organization, Toxicity, Patient, Bacteria, Sepsis, Antibiotics

Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs.

Key Points: 
  • Researchers have identified an entirely new class of antibiotic that can kill bacteria that are resistant to most current drugs.
  • It is responsible for around 20% of infections in places like hospitals, care homes or other similar healthcare settings.
  • Antibiotics commonly work by crossing the cell wall that surrounds infectious bacteria to reach the vital machinery inside.
  • Crab is a clinical challenge as it has a double-layered cell wall, a feature that microbiologists describe as “gram negative”.

Zosurabalpin

  • Researchers tested zosurabalpin against more than 100 Crab samples from patients suffering from the infection.
  • The research team, found that zosurabalpin was able to kill all of these bacterial strains.
  • Zosurabalpin works by blocking a molecular machine called LptB2FGC that transports the lipopolysaccharide toxin from the inside barrier to the outside one.
  • The bad news is that zosurabalpin will only kill Crab infections and not those caused by other types of bacteria.
  • Zosurabalpin is now in phase 1 clinical trial for use in patients infected with Crab.
  • This early testing in humans will help the company developing the drug, Roche, to work out any side effects of the drugs as well as potential toxicity.


Jonathan Cox receives research funding from UKRI, charities and industry.

He is Co-Director of the Antibiotic Discovery Accelerator (ABX) Network

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

Retrieved on: 
Tuesday, December 26, 2023
Hyperphosphatemia, Quality of life, Immunotherapy, Immune system, Klebsiella pneumoniae, FDA, PD-1, Renal cell carcinoma, Research, Bladder cancer, TKI, Cancer, Clinical trial, Pseudomonas aeruginosa, Acinetobacter baumannii, Chronic kidney disease, Phosphorus, Kidney disease, NMPA, BCG, Proteinuria, Escherichia coli, Kidney, Edema, National Medical Products Administration, Patient, Drug resistance, CKD, Dialysis, Gram-negative bacteria, Pharmaceutical industry

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.

ContraFect Announces FDA Clearance of CF-370 IND Application to Proceed With Phase 1 Clinical Study

Retrieved on: 
Monday, October 16, 2023
Infection, Klebsiella pneumoniae, Hospital, Disease, Food, Gram-negative bacteria, Campaign, Fungal infection, HAI, Trial of the century, Bacteria, Acinetobacter baumannii, Escherichia coli, Intellectual property, IND, CDC, Mortality, Enterobacter cloacae, VABP, State, Pseudomonas aeruginosa, Patient, FDA, XDR, MDR, Peptide, Clinical trial, Pneumonia, Gram, ICU, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Enterobacter, Bronchopneumonia, Pharmaceutical industry, MD, Enterobacteriaceae

“We are very pleased with the FDA’s clearance of our IND application for CF-370.

Key Points: 
  • “We are very pleased with the FDA’s clearance of our IND application for CF-370.
  • HABP/VABP occurs in patients in hospitals or other health care facilities and can be caused by a variety of bacteria.
  • P. aeruginosa, Acinetobacter species, Klebsiella species, E. coli and Enterobacter species are the most commonly implicated Gram-negative pathogens in HABP/VABP infections.
  • The HAI Progress Report includes data from 3,917 facilities reporting to the National Healthcare Safety Network covering 36.3 million hospital admissions.

T2 Biosystems Announces Preliminary Third Quarter 2023 Financial Results and Business Updates

Retrieved on: 
Thursday, October 12, 2023
ATM, COVID-19, Auris, Sepsis, Total, FDA, CRG, Instrument, International, Therapy, Video game, Medical device, Pharmaceutical industry, Acinetobacter baumannii

LEXINGTON, Mass., Oct. 12, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial results for the third quarter ended September 30, 2023 and business updates.

Key Points: 
  • LEXINGTON, Mass., Oct. 12, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced preliminary unaudited financial results for the third quarter ended September 30, 2023 and business updates.
  • Executed contracts for 5 T2Dx Instruments during the third quarter, including 2 in the U.S. and 3 internationally.
  • The Company’s third quarter 2023 financial results are preliminary and are subject to the completion of the review of the Company’s third quarter 2023 financial statements.
  • Complete third quarter 2023 financial results will be announced in November.

T2 Biosystems Announces FDA 510(k) Submission to Expand the Pathogen Detection on its FDA-Cleared T2Bacteria Panel to Include Detection of Acinetobacter baumannii

Retrieved on: 
Thursday, October 12, 2023
Bloodstream infections, Food, Bacteria, Intensive care medicine, Acinetobacter baumannii, Risk, Carbapenem, Mortality, World Health Organization, FDA, CE, Escherichia coli, Catheter, ICU, Regulation of tobacco by the U.S. Food and Drug Administration, Pseudomonas aeruginosa, Patient, Infection, Septic shock, Vaccine, Antibiotics

A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.

Key Points: 
  • A. baumannii is a cause of bloodstream infections especially in critically ill patients, which can range from a benign transient bacteremia to septic shock.
  • In a large study of nosocomial bloodstream infections, A. baumannii was the tenth most common pathogen and has a crude ICU mortality rate of 34.0% to 43.4%.
  • “We are excited about the potential to expand the number of pathogens detected by our FDA-cleared T2Bacteria Panel to include the detection of A. baumannii,” stated John Sperzel, Chairman and CEO of T2 Biosystems.
  • Rapid detection of these pathogens is essential to getting infected patients on the appropriate antimicrobial therapy and improving clinical outcomes.

Study Published in Science Translational Medicine Shows Exbaq’s Experimental Vaccine Protects Against Many of the Most Dangerous Antibiotic Resistant Superbugs Causing Hospital Acquired Infections

Retrieved on: 
Thursday, October 5, 2023
Patent, Partnership, Klebsiella pneumoniae, Infection, Methicillin-resistant Staphylococcus aureus, Homeland, Homeland security, Innovation, Acinetobacter baumannii, IND, Fungus, National Institute of Allergy and Infectious Diseases, Fungal infection, Hulk, Laboratory, Pseudomonas aeruginosa, Patient, FDA, Mucormycosis, R01, Macrophage, Escherichia coli, Immune system, USC, Bangladesh Technical Education Board, Vancomycin-resistant Enterococcus, ESBL, Korea Disease Control and Prevention Agency, Blood, Enterococcus, Translational medicine, Denise Spellberg, NIH, Vaccine, Pharmaceutical industry, Klebsiella, Science

Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.

Key Points: 
  • Multiple studies in different laboratories have confirmed the vaccine protected against serious infections within 24 hours and lasts for up to 28 days.
  • Early data suggest that a second dose may extend the window to prevent infection.
  • The study was published in Science and Translational Medicine.
  • These infections are often caused by highly antibiotic-resistant superbugs, many of which are targeted by this new ExBaq vaccine.