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Preclinical Development: Overview01:28

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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The global preclinical antibacterial pipeline.

Ursula Theuretzbacher1, Kevin Outterson2,3, Aleks Engel4

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The preclinical antibacterial drug pipeline shows diverse and innovative projects, focusing on Gram-negative pathogens. However, significant translational hurdles remain, requiring more work and funding for novel therapies against antibacterial resistance.

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Area of Science:

  • Microbiology and Infectious Diseases
  • Drug Discovery and Development
  • Antimicrobial Resistance

Background:

  • Antibacterial resistance poses a global health threat, necessitating new drug development.
  • Existing reviews focus on clinical pipelines, leaving preclinical antibacterial development largely unexamined.
  • Understanding the preclinical landscape is crucial for addressing the pipeline gap.

Purpose of the Study:

  • To comprehensively review the global antibacterial discovery and preclinical development pipeline.
  • To identify trends, innovations, and challenges in preclinical antibacterial research.
  • To focus on Gram-negative pathogens, including those on the WHO priority list.

Main Methods:

  • Systematic review of preclinical antibacterial projects as of May 1, 2019.
  • Analysis of 407 projects from 314 institutions.
  • Categorization of projects by therapeutic approach, targets, and pathogens.

Main Results:

  • Identified 407 preclinical antibacterial projects, with a strong emphasis on Gram-negative pathogens.
  • Highlighted 135 projects involving novel small molecules with new classes, targets, or mechanisms.
  • Observed a significant trend towards non-traditional approaches like antivirulence, microbiome modulation, phages, and probiotics.

Conclusions:

  • The preclinical pipeline is diverse and innovative, offering potential against resistant bacteria.
  • Non-traditional approaches and pathogen-specific strategies are emerging but face translational challenges.
  • Sustained investment and focused development are critical to translate preclinical promise into clinical therapies for antibacterial resistance.