Developing systemic & inhaled antibiotics for lung infections

Dear All:

I missed it personally, but by all reports the session on 3 June 2017 at ASM Microbe entitled “Development of New Drugs and Strategies for Hospital-Acquired Pneumonia Caused by MDR Pathogens” during ASM Microbe was an outstanding survey of this challenging area during which Shampa Das, Mike Dudley, and Sumati Nambiar gave great overview talks on these key topics:

  • (link) Shampa Das: Strategies to Get the Dose Right for Phase III Clinical Trials: What is Required? (link)
  • (link) Mike Dudley: Developing Combinations of Agents for Pneumonia: Indications, Regulation and Opportunities
  • (link) Sumati Nambiar: Regulatory Advances and Challenges for New Drug Development in HABP/VABP

In addition, Sumati gave a talk on inhaled antibiotics a few days later at the Aerosol Medicines meeting in Santa Fe, NM:

  • (link) Nambiar: “Antibacterial Drug Development: Challenges, Recent Developments, and Future Considerations to Improve Treatment of Lung Infections”

All 3 have graciously agreed to share copies of their talks (links as above). Given the importance of developing antibiotics for the lung, it is valuable to have such clearly articulated summaries to review. Some highlights to my eye:

  1. The talks by Shampa & Mike provide thorough tours of the challenge of dose selection and exposure validation for pneumonia products. Both cover approaches to the question of lung penetration with Mike going very deeply into questions of analyses for the two components of a BL-BLI combination and Shampa exploring at length issues around drug clearance covariates (e.g., accelerated renal clearance).
  2. Sumati’s talk on systemic agents for Nosocomial Pneumonia (HABP-VABP) gives a summary of the evolution of thinking in this area, current trial designs, the way these ideas intersect with the Unmet Need Guidance, and approaches to both narrow-spectrum and adjunctive agents.
  3. Finally, Sumati’s talk on inhaled agents covers program design issues for developers of drugs for non-tuberculous mycobacteria, cystic fibrosis (CF), non-CF bronchiectasis, and VABP. This is a very welcome summary of areas that I’ve not often seen discussed at length.

Many thanks to our colleagues … and happy reading!

Best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust

Follow me on Twitter: @JohnRex_NewAbx

Upcoming events of note outside of the mainstream large meetings:

  • 10-11 July: FDA workshop on bacteriophage therapies
  • 19 July: FDA workshop on combination therapy for TB
  • 5-9 Sep: ASM-ESCMID conference on antibiotic R&D, including the CARB-X + GARDP Antibiotic Bootcamp
  • 13 Sep 2017 (DC): FDA-CDRH workshop on diagnostic devices for detecting antimicrobial susceptibility & resistance

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