VABP

Spero Therapeutics Announces Clearance of IND for SPR206 to Treat MDR Gram-negative Bacterial Infections

Retrieved on: 
Wednesday, February 28, 2024
Pfizer, Infection, MDR, FDA, Food, Trial of the century, Prevalence, Safety, Fungal infection, Therapy, Pharmacokinetics, Disease, Gram-negative bacteria, Patient, IND, Mortality, VABP, Pharmaceutical industry

SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections.

Key Points: 
  • SPR206 is a novel, intravenously (IV) administered next-generation polymyxin antibiotic for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by MDR Gram-negative bacterial infections.
  • "Clearance of this IND is an important milestone in our SPR206 development program, as we prepare to advance this drug candidate into a Phase 2 trial in HABP/VABP," said Kamal Hamed, Spero’s Chief Medical Officer.
  • "HABP/VABP are serious infections associated with high mortality and substantial morbidity, and their management has been complicated by the increasing prevalence of difficult-to-treat and MDR Gram-negative pathogens.
  • SPR206 is subject to a license agreement with Pfizer Inc., which was made alongside Pfizer’s $40 million equity investment in Spero, previously announced in June 2021.

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.

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.

ContraFect Announces Submission of IND Application to the FDA for its Development Candidate CF-370

Retrieved on: 
Monday, September 18, 2023
State, Human, XDR, Probability, Gram, HAI, Infection, Drug discovery, Clinical trial, Bacterial pneumonia, Pharmacokinetics, Hope, Escherichia coli, Prognosis, Consultant, CDC, Pseudomonas aeruginosa, Death, MDR, VABP, Hospital, Patient, Disease, Toxicology, Fungal infection, Bronchopneumonia, Mortality, Bacteria, Campaign, ICU, FDA, Pharmacology, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Enterobacter cloacae, Food, Peptide, Pharmaceutical industry, Enterobacteriaceae, MD

The IND application supports a proposed indication for its intravenous (IV) antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).

Key Points: 
  • The IND application supports a proposed indication for its intravenous (IV) antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP).
  • New therapies to treat these infections are critically important to meet patient needs, particularly because of increasing antimicrobial resistance.
  • HABP/VABP occurs in patients in hospitals or other health care facilities and can be caused by a variety of bacteria.
  • Additionally, the application describes the manufacture of the drug substance and drug product to be used in human clinical trials.

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.

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.

Innoviva Reports First Quarter 2023 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Tuesday, May 9, 2023
Health, Infectious Diseases, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, GSK, Priority review, Entasis, Therapy, New Drug Application, NDA, Gonorrhea, Acinetobacter, Sale, VABP, Patient, PDUFA, Bronchopneumonia, FDA, Food, Cryptocurrency, Pharmaceutical industry

Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or “the Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the first quarter ended March 31, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.

Key Points: 
  • Innoviva, Inc. (NASDAQ: INVA) (“Innoviva” or “the Company”), a diversified holding company with a portfolio of royalties and other healthcare assets, today reported financial results for the first quarter ended March 31, 2023, highlighted select corporate achievements and provided an overview of its key business initiatives.
  • Net income was $34.9 million, or $0.51 basic per share, for the first quarter of 2023, compared to net income of $15.8 million, or $0.23 basic per share, for the first quarter of 2022.
  • During the first quarter of 2023, Innoviva repurchased approximately 3.4 million shares of its outstanding common stock for $40.3 million.
  • In January 2023, Innoviva paid off the remaining principal balance of $96.2 million of its convertible subordinated notes, due 2023.

OpGen Subsidiary Curetis and BioVersys Sign Collaboration Agreement for Clinical Trial Support

Retrieved on: 
Tuesday, October 25, 2022
GSK, Nadine Opgen-Rhein, Infection, European Investment Bank, Mortality, Securities Act of 1933, University, Acinetobacter baumannii, Tuberculosis, University of Lille, Solution, Adoption, Pneumonia, Bloodstream infections, AMR, Precision medicine, Private Securities Litigation Reform Act, GLOBE, Clinical trial, Phase, FDA, CRO, Rifabutin, Research, Security (finance), Technology, Goal, BSI, Securities Exchange Act of 1934, U.S. Securities and Exchange Commission, TRIC, Drug Quality and Security Act, Patient, Hospital, Subclinical infection, VABP, Nasdaq, Doctor of Philosophy, NGS, GlaxoSmithKline, COVID-19, Pharmaceutical industry, Vaccine, Curetis, MD

To ensure smooth and seamless operations, the Curetis team will train a team of trainers at BioVersys and their clinical research organization (CRO) for the Phase II trial.

Key Points: 
  • To ensure smooth and seamless operations, the Curetis team will train a team of trainers at BioVersys and their clinical research organization (CRO) for the Phase II trial.
  • All data pertaining to the clinical trial will be owned by BioVersys and can be used in their future clinical development and regulatory submissions as needed.
  • Oliver Schacht, PhD, Chief Executive Officer of OpGen Inc. added: The entire OpGen and Curetis team is excited to begin our collaboration with BioVersys and support their Phase II clinical trial of BV100 with our Unyvero platform.
  • This press release includes statements regarding the collaboration agreement entered into by OpGens subsidiary Curetis GmbH and BioVersys AG for their BV100 phase II clinical trial.

Entasis Therapeutics announces positive topline results for sulbactam-durlobactam (SUL-DUR) from Phase 3 ATTACK trial

Retrieved on: 
Monday, October 18, 2021
Division, CDC, Entasis, Acinetobacter, Conference, GLOBE, Forward-looking statement, Bacteria, Private Securities Litigation Reform Act, Sulbactam, Test, Intensive care unit, NDA, Infection, Time-invariant system, Mortality, VP, Clinical trial, Patient, Failure, CEO, ABC, Diversified Specialty Institute Holdings, Inc., Polymyxin B, Skin, Subclinical infection, BLI, U.S. Securities and Exchange Commission, Nephrotoxicity, Production part approval process, AES, Data monitoring committee, Nasdaq, Disease, Colistin, Pneumonia, Bloodstream infections, TOC, Safety, VABP, Gram, MPH, Pig, Pharmaceutical industry, Health insurance, Vaccine

ATTACK was a landmark clinical trial, the first to successfully evaluate an investigational agent targeting a specific drug-resistant Gram-negative pathogen.

Key Points: 
  • ATTACK was a landmark clinical trial, the first to successfully evaluate an investigational agent targeting a specific drug-resistant Gram-negative pathogen.
  • The positive outcome of the ATTACK trial is the culmination of a tremendous effort by our team, and a major milestone for Entasis.
  • The data from the ATTACK trial are robust and incredibly exciting, demonstrating positive safety and efficacy results, combined with favorable and meaningful clinical cure rates.
  • The global Phase3 registrational ATTACK trial was initiated in April 2019 with positive Phase 3 topline data announced in October 2021.