Gram-negative bacteria

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.

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.

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.

Allecra Therapeutics Announces U.S. FDA Approval for EXBLIFEP® for the Treatment of Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, February 27, 2024
Health, FDA, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Therapy, ESBL, GAIN, Second Continental Congress, Urinary tract infection, Supervisory board, Pharmaceutics, Cutis, Partnership, Food, Pyelonephritis, Gram-negative bacteria, Patient, Congress, Medication, Pharmaceutical industry

Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.

Key Points: 
  • Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (FDA) has approved EXBLIFEP® (cefepime/enmetazobactam), as a treatment for complicated urinary tract infections (cUTIs), including pyelonephritis, in patients 18 years and older.
  • Allecra has also received a five-year marketing exclusivity extension from the FDA as part of the Generating Antibiotic Incentives Now Act (GAIN Act).
  • "Receiving FDA approval is a tremendous achievement for Allecra and a testament to the hard work and dedication of a small, yet highly focused team of individuals.
  • Enmetazobactam was first discovered by Orchid Pharma and all rights outside India were assigned to Allecra Therapeutics in 2013.

The Wound Pros Launches Wound Care Without Walls Program in Nigeria

Retrieved on: 
Monday, March 4, 2024
Psoriasis, Acne, LOS, FDA, Wound, Bacteria, Burns, Medicine, WCWW, Dermatitis, Gram-negative bacteria

LOS ANGELES, March 4, 2024 /PRNewswire/ -- Dr. Chris Otiko, co-founder and corporate treasurer at The Wound Pros: https://www.thewoundpros.com, was recently in Abuja, Nigeria's capital, to launch the company's Wound Care Without Walls (WCWW) program and introduce Tetracyte.

Key Points: 
  • The Wound Pros extends its healing services into Nigeria.
  • Promotes Tetracyte product
    LOS ANGELES, March 4, 2024 /PRNewswire/ -- Dr. Chris Otiko, co-founder and corporate treasurer at The Wound Pros: https://www.thewoundpros.com , was recently in Abuja, Nigeria's capital, to launch the company's Wound Care Without Walls (WCWW) program and introduce Tetracyte.
  • Otiko was accompanied by Texas resident Adebola Adefuye, clinical supervisor for The Wound Pros' Complex Wound Management Team.
  • Otiko and Adebola also had strategy discussions with Wound Pros employees in Nigeria, focusing on marketing avenues to launch product sales in Nigeria.

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.

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
Urine, Medical Subject Headings, Diarrhea, Marketing, Agency, INN, Infection, Allergy, ATC, Carbapenem, International, Cough, Nausea, Language, Urinary tract infection, European Medicines Agency, Cilastatin, Bloodstream infections, Imipenem, Select, Patient, Iron, Bacteria, Anatomy, Penicillin, Vomiting, IIA, Gram-negative bacteria, Medical device

Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Fetcroja, cefiderocol, Date of authorisation: 23/04/2020, Revision: 8, Status: Authorised

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.

How do bacteria actually become resistant to antibiotics?

Retrieved on: 
Wednesday, November 8, 2023
Survival, Urinary tract infection, Growth, Reproduction, Staphylococcus aureus, Escherichia coli, Gram, Antimicrobial spectrum, Health, Plasmid, Vancomycin, Gram-positive bacteria, Method, Solution, Genetic code, Enzyme, Ciprofloxacin, Environment, Erythromycin, Cell membrane, Staphylococcus, Food security, Gene, Aminoglycoside, Population, Cell wall, Patient, Gram-negative bacteria, DNA, Food preservation, Vaccine, Antibiotics, Poultry farming, Bacteria

“What doesn’t kill me makes me stronger”, originally coined by Friedrich Nietzsche in 1888, is a perfect description of how bacteria develop antibiotic resistance.

Key Points: 
  • “What doesn’t kill me makes me stronger”, originally coined by Friedrich Nietzsche in 1888, is a perfect description of how bacteria develop antibiotic resistance.
  • Contrary to a common belief, antibiotic resistance is not about your body becoming resistant to antibiotics.

How bacteria adapt

  • The ability for bacteria to adapt lies in part with their astonishing rate of reproduction.
  • While most changes are bad, sometimes they can help the bacteria grow in the presence of an antibiotic.
  • This evolution of resistance can be seen by growing bacteria on a large agar plate (a nutrient support that bacteria like to grow on) with zones of increasing antibiotic levels.

They also exchange genetic material

  • The other key mechanism enabling bacterial resistance is the exchange of genetic information between bacteria.
  • In addition to the main chunk of DNA that encodes the bacterial genome, bacteria can host circular DNA snippets called plasmids.
  • Plasmid exchange usually occurs by direct physical contact between bacteria.

4 ways bacteria resist

  • Gram-positive bacteria like Staphylococcus aureus have a thick cell wall enclosing a lipid membrane.
  • Antibiotics can hijack these entry routes, but bacteria can modify the cell wall, cell membrane and entry proteins to block antibiotic penetration.
  • For example, bacteria increase the thickness of the cell wall to resist antibiotics like vancomycin.
  • Bacteria have machinery known as efflux pumps, which regurgitate unwanted molecules from within the bacteria.
  • Bacteria can alter the pump so it is more effective at removing the antibiotic, or they can simply make more pumps.
  • Antibiotics, like most other drugs, generally work by blocking the function of important enzymes within the bacteria.
  • If bacteria alter the target shape by changing the DNA/protein sequence, the antibiotic (key) can no longer bind to its target (lock).

Bacteria vs antibiotics

  • While bacteria have developed mechanisms to resist antibiotics, these adaptations can come at a “fitness” cost.
  • Bacteria may grow more slowly, or can be killed more easily by another antibiotic.
  • This has led to the concept of “collateral sensitivity” to prevent or overcome resistance when treating patients, by using pairs of antibiotics.


Mark Blaskovich receives funding from a range of government, not-for-profit and commercial organisations for research into antibiotic discovery and development. He is affiliated with AAMRNet (Australian Antimicrobial Resistance Network), an organisation promoting improved care and development of antibiotics and antibiotic alternatives.