SAN DIEGO, CA, USA I September 13, 2017 I Geom Therapeutics, Inc., today announced a Clinical Trial Agreement (CTA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to conduct a Phase I study with GT-1, Geom Therapeutics’ lead drug candidate. GT-1 is a cephalosporin antibiotic with a novel uptake mechanism and broad-spectrum activity against Gram-negative bacteria, including multidrug-resistant (MDR) Pseudomonas aeruginosa and Acinetobacter species.
GT-1 has demonstrated excellent in vitro and in vivo activity against pathogens that have been identified by the World Health Organization (WHO) as priority pathogens. The recent WHO Global Priority List of Antibiotic-Resistant Bacteria (2017) highlights the most critical MDR pathogens, including Acinetobacter spp. and P. aeruginosa, which can cause severe and often deadly infections, such as bloodstream infections and pneumonia.
Under the agreement between NIAID and Geom Therapeutics, the NIAID-supported Phase I Clinical Trial Units for Therapeutics plans to conduct a double-blind, placebo-controlled, dose-escalating study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of GT-1 in healthy volunteers. This trial will be conducted at Duke University (Contract # HHSN272201500005I).
“New therapeutic options are urgently needed to combat the continued increase of bacterial resistance to current antimicrobial therapy, especially for MDR and pan-resistant Gram-negative pathogens. We are looking forward to the support from NIAID and its research network to initiate the clinical development of GT-1, a potential therapy to address these urgent needs,” notes Dirk Thye, M.D., Executive Chairman of Geom Therapeutics, Inc.
About GT-1
GT-1 is a novel siderophore cephalosporin antibiotic and is being developed for the treatment of MDR Gram-negative bacterial infections. GT-1 is actively transported into Gram-negative cells by exploiting iron uptake systems that use low molecular weight iron-binding molecules, known as siderophores, to transport iron into the cells. This “Trojan Horse” strategy facilitates the uptake of GT-1 into the bacterial periplasmic space in high concentrations where GT-1 binds to its penicillin-binding protein targets and disrupts cell wall synthesis, leading to cell death. This increased transportation into bacterial cells potentiates activity against Gram-negative bacteria, including activity against MDR Acinetobacter spp. and P. aeruginosa. All IND-enabling studies have been completed for GT-1 and Geom Therapeutics plans to submit an IND to the FDA in 2H 2017. More information about GT-1 can be viewed at: http://www.geomtherapeutics.com
About Geom Therapeutics
Geom Therapeutics is a biotechnology company focused on the development of novel antibiotics for MDR Gram-negative infections. We are a joint venture with LegoChem Biosciences, a publicly traded Korean biotechnology company (KOSDAQ:141080) and the inventor of GT-1. GT-1, our lead product candidate, a cephalosporin with a novel uptake mechanism, has demonstrated broad spectrum efficacy against Gram-negative pathogens. We are developing GT-1 for serious bacterial infections, including those caused by MDR P. aeruginosa and Acinetobacter spp. We have built an exceptional research and development team with deep expertise in the development of new antibiotics from discovery through approval. Our mission is to improve patients’ lives by developing novel antibiotics to treat resistant infections for which there are no available therapies. For more information, please visit us at www.geomtherapeutics.com.
About NIAID
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research – at the National Institutes of Health (NIH), throughout the United States, and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov. The NIH – The U.S. Medical Research Agency – includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
SOURCE: Geom Therapeutics, Inc.
Post Views: 256
SAN DIEGO, CA, USA I September 13, 2017 I Geom Therapeutics, Inc., today announced a Clinical Trial Agreement (CTA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to conduct a Phase I study with GT-1, Geom Therapeutics’ lead drug candidate. GT-1 is a cephalosporin antibiotic with a novel uptake mechanism and broad-spectrum activity against Gram-negative bacteria, including multidrug-resistant (MDR) Pseudomonas aeruginosa and Acinetobacter species.
GT-1 has demonstrated excellent in vitro and in vivo activity against pathogens that have been identified by the World Health Organization (WHO) as priority pathogens. The recent WHO Global Priority List of Antibiotic-Resistant Bacteria (2017) highlights the most critical MDR pathogens, including Acinetobacter spp. and P. aeruginosa, which can cause severe and often deadly infections, such as bloodstream infections and pneumonia.
Under the agreement between NIAID and Geom Therapeutics, the NIAID-supported Phase I Clinical Trial Units for Therapeutics plans to conduct a double-blind, placebo-controlled, dose-escalating study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of GT-1 in healthy volunteers. This trial will be conducted at Duke University (Contract # HHSN272201500005I).
“New therapeutic options are urgently needed to combat the continued increase of bacterial resistance to current antimicrobial therapy, especially for MDR and pan-resistant Gram-negative pathogens. We are looking forward to the support from NIAID and its research network to initiate the clinical development of GT-1, a potential therapy to address these urgent needs,” notes Dirk Thye, M.D., Executive Chairman of Geom Therapeutics, Inc.
About GT-1
GT-1 is a novel siderophore cephalosporin antibiotic and is being developed for the treatment of MDR Gram-negative bacterial infections. GT-1 is actively transported into Gram-negative cells by exploiting iron uptake systems that use low molecular weight iron-binding molecules, known as siderophores, to transport iron into the cells. This “Trojan Horse” strategy facilitates the uptake of GT-1 into the bacterial periplasmic space in high concentrations where GT-1 binds to its penicillin-binding protein targets and disrupts cell wall synthesis, leading to cell death. This increased transportation into bacterial cells potentiates activity against Gram-negative bacteria, including activity against MDR Acinetobacter spp. and P. aeruginosa. All IND-enabling studies have been completed for GT-1 and Geom Therapeutics plans to submit an IND to the FDA in 2H 2017. More information about GT-1 can be viewed at: http://www.geomtherapeutics.com
About Geom Therapeutics
Geom Therapeutics is a biotechnology company focused on the development of novel antibiotics for MDR Gram-negative infections. We are a joint venture with LegoChem Biosciences, a publicly traded Korean biotechnology company (KOSDAQ:141080) and the inventor of GT-1. GT-1, our lead product candidate, a cephalosporin with a novel uptake mechanism, has demonstrated broad spectrum efficacy against Gram-negative pathogens. We are developing GT-1 for serious bacterial infections, including those caused by MDR P. aeruginosa and Acinetobacter spp. We have built an exceptional research and development team with deep expertise in the development of new antibiotics from discovery through approval. Our mission is to improve patients’ lives by developing novel antibiotics to treat resistant infections for which there are no available therapies. For more information, please visit us at www.geomtherapeutics.com.
About NIAID
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research – at the National Institutes of Health (NIH), throughout the United States, and worldwide – to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov. The NIH – The U.S. Medical Research Agency – includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
SOURCE: Geom Therapeutics, Inc.
Post Views: 256
