NIAID Funding opportunity + FDA guidance x 3: revisions for cIAI and cUTI + new for uUTI (draft)

Dear All:

First up, NIAID has released a BAA (Broad Agency Announcement) regarding up to $15.5m in funds for awards in two research areas. Here is a brief description … see below my signature for more details. To my eye, this looks like a very broad and inclusive call for proposals. 

  • Area 1: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases
  • Area 2: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases

Second, FDA has released three guidance documents. The first two (cIAI and cUTI) are updated guidance documents that provide some fixes that I believe help bring FDA and EMA into closer harmonization, something that is very important for global development! The third is a very welcome draft guidance document for uUTI:

  • The Feb 2015 cIAI (complicated intra-abdominal infection) guidance has been revised effective May 2018.
    • comparison document generated by Acrobat suggests that the changes are minor. I note that upper GI perforations are now disallowed unless there is an established secondary infection but see little else beyond some small typography fixes.
  • Ditto for the Feb 2015 cUTI (complicated UTI) guidance now revised effective June 2018.
    • An Acrobat comparison document shows that the main change is that the preferred CFU/ml cutoff for success is now 1,000 CFU/mL rather than 10,000 CFU/mL. A comment in the Appendix suggests that the two cut-off values have similar performance but the lower cut-off is preferred.
  • New draft guidance for uUTI (uncomplicated UTI), effective May 2018.
    • This is very good to see! It proposes a primary endpoint of clinical + microbiological response (here again the 1,000 CFU/mL cutoff appears) and provides a justification in its appendix for a non-inferiority margin of 10%.

Many thanks to both Team NIAID and Team FDA for their continued efforts!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

NIAID BAA — addtional details:

  • Research Area 001: Development of Therapeutic Products for Biodefense, Anti-Microbial Resistant (AMR) Infections and Emerging Infectious Diseases
    • The objective of this Research Area is the development of broad-spectrum therapeutic products for use in post-event settings following the intentional release of select pathogens, or in response to naturally-occurring outbreaks of infectious diseases caused by pathogens identified in this Research Area.
    • Solicited products are anticipated to include: Antibacterial Therapeutics; Antiviral Therapeutics; and, Anti-toxin Therapeutics.
  • Research Area 002: Advanced Development of Vaccine Candidates for Biodefense and Emerging Infectious Diseases
    • The objective of this Research Area is the development of vaccines for scenarios associated with intentional release of a NIAID Category A, B, or C Priority Pathogen, or in response to naturally-occurring outbreaks of infectious diseases caused by these pathogens or Zika virus (Zika virus vaccine would be included only as a component of a multivalent vaccine for other pathogens such as a vaccine for Flavivirus family).
    • Solicited Products are anticipated to include: Technology Gaps that Slow Progression to Clinical Testing; Novel Vaccine “Plug-and-Play” Technologies; Enhanced Vaccine Performance (with special interest in simplicity and speed of delivery, rapid immune response and sterilizing immunity); and Vaccines Against Antimicrobial Resistance Threats.

Upcoming meetings of interest to the AMR community:

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