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Designing development programs for non-traditional antibacterial agents.

John H Rex1,2, Holly Fernandez Lynch3, I Glenn Cohen4,5

  • 1F2G Limited, Eccles, Cheshire, M30 0LX, UK. john.rex@f2g.com.

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|August 2, 2019
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The distinction between traditional and non-traditional antibacterial agents is less relevant for regulatory approval. Most agents can be developed using existing clinical trial designs and regulatory frameworks for antibacterial resistance.

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Area of Science:

  • Microbiology and Infectious Diseases
  • Drug Development
  • Regulatory Science

Background:

  • Rising rates of antibacterial resistance necessitate diverse therapeutic strategies.
  • Non-traditional antibacterial agents offer alternatives to conventional small-molecule drugs.
  • Current regulatory frameworks may not fully accommodate all novel antibacterial approaches.

Purpose of the Study:

  • To evaluate the regulatory relevance of distinguishing between traditional and non-traditional antibacterial agents.
  • To propose a unified approach for the development and approval of novel antibacterial therapies.
  • To identify potential needs for extending current regulatory paradigms for population-level benefit agents.

Main Methods:

  • Perspective-based analysis of current regulatory frameworks for drug development.
  • Review of existing clinical trial designs for demonstrating efficacy.
  • Discussion of the classification and regulatory pathways for antibacterial agents.

Main Results:

  • The distinction between traditional and non-traditional antibacterial agents has limited relevance for most regulatory purposes.
  • Standard clinical efficacy measures and trial designs (non-inferiority/superiority) are applicable to most agents.
  • Agents targeting population-level benefits may require extensions of current regulatory paradigms.

Conclusions:

  • Most antibacterial agents, regardless of classification, can be developed within existing regulatory frameworks.
  • Regulatory pathways should focus on demonstrating clinical efficacy through established trial designs.
  • Further discussion is needed within the development community regarding regulatory approaches for population-level benefit agents.