Bacterial pneumonia

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Mercredi, avril 3, 2024

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Sugary handshakes are how cells talk to each other − understanding these name tags can clarify how the immune system works

Retrieved on: 
Jeudi, février 8, 2024

Unlike people, cells perform these handshakes using the diverse range of sugar molecules coating their surface like trees covering a landscape.

Key Points: 
  • Unlike people, cells perform these handshakes using the diverse range of sugar molecules coating their surface like trees covering a landscape.
  • Handshakes between these sugar molecules, or glycans, trigger cells to react in specific ways toward each other, such as escape, ignore or destroy.

What are glycans?

  • The vast number of possible glycan structures that can be built from connecting these sugar molecules together allows glycans to store rich information.
  • Glycans are chemically bonded to proteins and lipids on the surface of red blood cells.
  • Notably, the surface of type A red blood cells have glycans that differ from the glycans on the surface of type B and type O red blood cells.
  • For example, distinctive glycoproteins cover the surface of the viruses that cause COVID-19, HIV and H1N1 influenza and help them infect cells.
  • Glycolipids also coat many bacteria, allowing them to stick to their hosts and protect them from viruses and immune cells.

How do cells read glycans?

  • Found on surfaces of certain immune cells, these lectins deliver the glycans to proteins on other immune cells that can now selectively destroy any viruses or cells that carry that glycan.
  • For example, these lectins recognize glycans on the surfaces of cancer cells and direct other immune cells to eliminate these cancer cells.
  • Another type of lectin called siglecs are found on surfaces of immune cells and help them distinguish self from nonself, that is, between the cells that make up the body and the cells that are foreign to the body.
  • The bacterial glycans in the vaccine trigger an immune response when immune cells recognize the glycans as foreign threats.

Examining every sugar molecule

  • Comprehensively extracting all the information stored in glycans is very difficult because there isn’t currently technology able to analyze the complex and diverse structures of glycans.
  • Individual glycans are composed of sugar molecules in unique arrangements, but current analytical tools can only simultaneously analyze many glycans.


My lab is confronting this challenge by developing imaging technology that can analyze the structure of glycans by imaging each individual molecule. Essentially, we’re developing a technique to open the jar and study every single candy one at a time. In the long run, my team aspires to unveil how these glycans present themselves to the proteins that recognize them and, finally, reveal the very language that cells use to express themselves.
Kelvin Anggara works for the Max Planck Institute for Solid State Research and receives funding from the European Research Council under Project GlycoX (101075996).

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

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Lundi, septembre 18, 2023

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.

Eagle Pharmaceuticals Announces First Patient Randomized in Phase 2 Study Evaluating CAL02, a Novel First-in-Class Anti-Toxin Drug Candidate, in Severe Community-Acquired Bacterial Pneumonia (SCABP)

Retrieved on: 
Lundi, juillet 24, 2023

The Phase 2 study plans to enroll approximately 276 patients with SCABP at more than 100 sites in over 20 countries worldwide.

Key Points: 
  • The Phase 2 study plans to enroll approximately 276 patients with SCABP at more than 100 sites in over 20 countries worldwide.
  • In addition, depending upon recruitment rates, Eagle anticipates having its first 50% interim report around the first quarter of 2024.
  • CAL02 is a novel first-in-class broad-spectrum anti-virulence agent being developed as an add-on to standard of care treatment of SCABP.
  • In August 2021, Eagle entered into a worldwide licensing agreement with Combioxin SA for the commercial rights to CAL02.

Eagle Pharmaceuticals Receives FDA Qualified Infectious Disease Product (QIDP) and Fast-Track Designation for CAL02, Providing Five-Year Exclusivity Extension

Retrieved on: 
Mercredi, juin 14, 2023

CAL02 would serve as an add-on to standard of care antibiotic therapy for the prompt treatment of severe bacterial pneumonia and its devastating consequences.

Key Points: 
  • CAL02 would serve as an add-on to standard of care antibiotic therapy for the prompt treatment of severe bacterial pneumonia and its devastating consequences.
  • This treatment could represent a true paradigm shift and offer healthcare providers another option in combating this complex disease,” stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
  • Eagle believes that CAL02 could also be eligible for breakthrough therapy designation.
  • Eagle is also further developing the patent estate to protect the intellectual property resulting from the development of this novel, first-in-class therapy.

OpGen Enters Into Distribution Agreement for Unyvero in the U.S. with Fisher Healthcare

Retrieved on: 
Mardi, avril 18, 2023

The agreement is for the distribution of OpGen’s Unyvero A50 platform and in vitro diagnostic (IVD) tests for bacterial pneumonia (Unyvero LRT and LRT BAL) as well as its research use only (RUO) test for urinary tract infection (Unyvero UTI).

Key Points: 
  • The agreement is for the distribution of OpGen’s Unyvero A50 platform and in vitro diagnostic (IVD) tests for bacterial pneumonia (Unyvero LRT and LRT BAL) as well as its research use only (RUO) test for urinary tract infection (Unyvero UTI).
  • The Unyvero LRT cartridge for hospitalized patients with suspected pneumonia is the first ever FDA cleared IVD product specifically targeting bacterial pneumonia and antimicrobial resistance markers.
  • The Unyvero UTI cartridge has recently completed its pivotal clinical trial and OpGen has recently submitted a De Novo classification request for Unyvero UTI to the FDA.
  • Under the distribution agreement, Fisher Healthcare will have access to the Unyvero A50 platform and products to distribute and sell to hospitals and laboratories across the United States.

Sepsis - Pipeline Insight, 2022: Innovations from SciClone, Sanofi, BioAegis & More Set to Transform Sepsis Treatment - ResearchAndMarkets.com

Retrieved on: 
Mercredi, mars 8, 2023

This "Sepsis- Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Sepsis pipeline landscape.

Key Points: 
  • This "Sepsis- Pipeline Insight, 2022" report provides comprehensive insights about 40+ companies and 40+ pipeline drugs in Sepsis pipeline landscape.
  • The companies and academics are working to assess challenges and seek opportunities that could influence Sepsis R&D.
  • This segment of the Sepsis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery.
  • Sepsis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101

Retrieved on: 
Mercredi, octobre 5, 2022

(Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.

Key Points: 
  • (Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.
  • Weve made tremendous progress with the early development of this potentially game-changing technology to specifically address bacterial biofilms, which is a major driver of resistance in bacterial infections, said David Richards, Chief Executive Officer, Clarametyx.
  • Collectively, these infections contribute substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality.
  • CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Mercredi, octobre 5, 2022

The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Bacterial Pneumonia Epidemiology and Market Forecast 2022-2032 - ResearchAndMarkets.com

Retrieved on: 
Mardi, août 2, 2022

The "Bacterial Pneumonia - Market Insight, Epidemiology and Market Forecast -2032" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Bacterial Pneumonia - Market Insight, Epidemiology and Market Forecast -2032" report has been added to ResearchAndMarkets.com's offering.
  • This "Bacterial Pneumonia- Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the Bacterial Pneumonia, historical and forecasted epidemiology as well as the Bacterial Pneumonia market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
  • The Bacterial Pneumonia market report provides current treatment practices, emerging drugs, Bacterial Pneumonia market share of the individual therapies, current and forecasted Bacterial Pneumonia market Size from 2019 to 2032 segmented by seven major markets.
  • The Report also covers current Bacterial Pneumonia treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.