A Federal Register notice has been released announcing a 16 Nov 2017 FDA Antimicrobial Drugs Advisory Committee meeting to review Bayer’s inhaled ciprofloxacin for reduction of exacerbations in adults with non-cystic fibrosis bronchiectasis with respiratory bacterial pathogens (NCFB). Post-meeting addendum: Materials from the meeting can be found here. You might also want to look at materials from the 11 Jan 2018 AdComm on Aradigm’s inhaled ciprofloxacin (link).
The data are almost certainly from the RESPIRE 1 and 2 trials: “The RESPIRE programme consists of two international phase III prospective, parallel-group, randomized, double-blinded, multicentre, placebo-controlled trials of the same design. Adult patients with idiopathic or post-infectious NCFB, a history of ≥ 2 exacerbations in the previous 12 months, and positive sputum culture for one of seven pre-specified pathogens, undergo stratified randomization 2:1 to receive twice-daily Ciprofloxacin DPI 32.5 mg or placebo using a pocket-sized inhaler in one of two regimens: 28 days on/off treatment or 14 days on/off treatment. The treatment period is 48 weeks plus an 8-week follow-up after the last dose. The primary efficacy endpoints are time to first exacerbation after treatment initiation and frequency of exacerbations using a stringent definition of exacerbation. Secondary endpoints, including frequency of events using different exacerbation definitions, microbiology, quality of life and lung function will also be evaluated.”
In short, an identical pair of placebo-controlled studies using endpoints focused on the clinical outcome of time to exacerbation. This will be an important benchmark datum for those interested in developing inhaled drugs for pulmonary infections. Mark your calendars!
All 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. See past newsletters and subscribe for the future: http://amr.solutions/blog/
Upcoming meetings of interest to the AMR community:
- 1 Oct 2017 (London): BSAC: AMR Market Lounges. Networking day.
- 4-8 Oct 2017 (San Diego): IDWeek
- 10 Oct 2017 (Hanoi): UK-Vietnam Newton Fund Pre-Call Workshop on Partnership for Infectious Disease Research 2017
- 12-13 Oct 2017 (Berlin): AMR Call to Action Conference – contact email@example.com for more info
- 15 Oct 2017: Global Handwashing Day!
- 29 Oct-1 Nov 2017 (Santa Fe): Keystone Symposium – Antimicrobials and Resistance: Opportunities and Challenges
- 2 Nov 2017 (London): BSAC: AMR Market Lounges. Networking day.
- [NEW] 3 Nov 2017 (no specific location): One Health Day
- 6 Nov 2017 (Boston): BAARN (Boston-Area Antimicrobial Resistance Network), Annual Meeting for 2017
- 7-8 Nov 2017 (Washington, DC): BARDA Industry Days
- 11-19 Nov 2017 (Annecy, France): International Course on Antibiotics and Resistance (ICARE)
- 13-19 Nov 2017 WHO’s World Antibiotic Awareness Week
- 20 Nov 2017 (week of, China): UK-China Newton Fund Workshop: Antimicrobial Resistance Centre Partnerships Initiative.
- 20 Nov 2017 (London): Early Career Researcher Workshop on Diagnostics for Antimicrobial Resistance.
- 24-27 Nov 2017 (Taipei): 30th International Congress of Chemotherapy & Infection (ICC)
- 12-14 Feb 2018 (Baltimore): ASM Biothreats Conference
- 11-16 Mar 2018 (Ventura Beach): Gordon Research Conference on Antibacterial Discovery
- 21-24 Apr 2018 (Madrid): ECCMID
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture