3 June 2022 FDA workshop: Developing for uncomplicated UTI (uUTI)

Dear All,

It doesn’t rain … it pours! Just seconds after sending out a newsletter on the 18 May et seq. Squash Superbugs Day of Action, I learned that FDA has announced a 3 June 2022 workshop on uUTI!

From their webpage on the event: “The workshop will focus on nonclinical and clinical considerations regarding antimicrobial drug development for uncomplicated UTI. Discussions are planned around the following areas:

  • “Current state of clinical care for uUTI
  • “Nonclinical considerations and pathophysiology
  • “Microbiological and clinical pharmacology tools and approaches
  • “Trial design considerations, including the composite primary endpoint of clinical and microbiological success”


Hmm! I have no specific data, but I’d guess that this workshop is prompted in part by the Phase 3 experience for both sulopenem and tebipenem. Is it possible that close inspection of these datasets has suggested that we may need to consider adjustments to FDA’s August 2019 uUTI guidance? I look forward to this workshop!

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.

Current funding opportunities (most current list is here)

  • The AMR Industry Alliance has announced their 2022 Stewardship Prize! The program offers 10,000 CHF to recognize established, innovative approaches to AMR stewardship in low- and middle-income countries (LMICs). The 2021 prize went to the Infectious Diseases Institute (IDI) in Kampala, Uganda for their best practices in diagnostic stewardship and for their patient awareness campaigns dedicated to decreasing inappropriate use of antibiotics in their specialist HIV clinic in Kampala. Applications for the 2022 prize are due August 31, 2022. Thinking in terms of stewardship, WHO have recently released a pair of courses through the OpenWHO platform:
  • The AMR Action Fund is now open to proposals for funding of Phase 2 / Phase 3 antibacterial therapeutics. Per its charter, the fund prioritizes investment in treatments that address a pathogen prioritized by the WHO, the CDC and/or other public health entities that: (i) are novel (e.g., absence of known cross-resistance, novel targets, new chemical classes, or new mechanisms of action); and/or (ii) have significant differentiated clinical utility (e.g., differentiated innovation that provides clinical value versus standard of care to prescribers and patients, such as safety/tolerability, oral formulation, different spectrum of activity); and (iii) reduce patient mortality. It is also expected that such agents would have the potential to strongly address the likely requirements for delinked Pull incentives such as the UK (NHS England) subscription pilot and the PASTEUR Act in the US. Submit queries to contact@amractionfund.com.
  • INCATE (Incubator for Antibacterial Therapies in Europe) is a newly launched early-stage funding vehicle. Details are still coming into focus, but per comments on 25 Aug 2021 at the BIOCOM conference, their goal is to support ~4 companies per year with about $250k/company. Contact details are on their website (https://www.incate.net/).
  • CARB-X recently announced that their existing resources will be reserved to fund their existing portfolio (more than 80 total awards, and counting, as they include contracting from prior rounds). New rounds from CARB-X will occur only after new funding is obtained in 2021.
  • It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
  • The Global AMR R&D Hub’s dynamic dashboard (link) summarizes the global clinical development pipeline, incentives for AMR R&D, and investors/investments in AMR R&D.
  • In addition to the lists provided by the Global AMR R&D Hub, you might also be interested in my most current lists of R&D incentives (link) and priority pathogens (link).


Upcoming meetings of interest to the AMR community (most current list is here):

  • 8 Dec 2021: “The New Winds Pushing and Pulling Antibacterial Development.” This FABULOUS program featured talks from the UK team behind the NHS “Netflix” pilot, Kevin Outterson’s recently released report documenting the need for global Pull incentives to have a value of $2.2 – 4.8b, and speakers covering PASTEUR and work in the EU on pull incentives. The video is here — please make time to listen to this program!
  • The stunning 4 Feb 2022 webinar for the GRAM report (Global Research on Antimicrobial Resistance “1.27 million deaths per year are directly attributable to AMR”) is now available for replay. #AMRSOS! 
  • 18 May 2022 (in-person and virtual, 4-6p East Coast, Washington DC): Salt in My Soul is a remarkable movie in which Mallory Smith, a patient with CF who ultimately succumbed to infection, documents her struggle “to live fully while dying.” At the in-person event (Capitol Visit Center, HVC-215), a screening of the movie’s trailer will be followed by a discussion; go here to register and for a link that allows you to view the full-length movie. The event will also be live on Facebook
  • 18 May 2022 (call to action on this day): The Valley Fever Institute at Kern Medical is calling for social media action on AMR (in particular vs. Valley Fever, aka coccidioidomycosis). They suggest adding hashtag #ValleyFever to #SquashSuperbugs for fungus-related posts. Go here for their online call to action and here for their call to action flyer.
  • 19 May 2022 (virtual): Joint webinar by FAO, OIE, WHO and UNEP entitled “Monitoring national action plans on antimicrobial resistance at country level – best practices”. Go here for details. 
  • 24 May 2022 (virtual, 1-2p East Coast), The Pew Charitable Trust is sponsoring an event with The Hill entitled “Antibiotic Resistance: A Looming Public Health Crisis.” Speakers will include US Senator Michael Bennet (D-CO) and US Representative Drew Ferguson (R-GA) as well as a patient survivor, IDSA, and CARB-X. Go here for details! 
  • 31 May 2022 (virtual, 15:00-18:00, Finland): “Antibiotics for Life”, a webinar sponsored by TGAR (The Global Antibiotics Resistance Foundation) that will discuss stewardship and innovation from a Nordic perspective. Go here to register.
  • [NEW] 3 Jun 2022 (virtual, 9a-5p ET): FDA-sponsored workshop entitled “Drugs for the Treatment of Uncomplicated Urinary Tract Infections (UTI)” that will focus on “nonclinical and clinical considerations regarding antimicrobial drug development for uncomplicated UTI.” Go here for more details and to register.
  • 7 Jun 2022 (virtual, 9-10.30a East Coast). CDC-sponsored webinar entitled “Antifungal Resistance: Understanding this Growing Global Threat.” Hosted by the team at CDC’s Mycotic Diseases Division, this looks to be an excellent conversation. Go here to register.
  • 8-9 Jun 2022 (virtual, 15.00-18.00 CEST / 9.00-12.00 EDT on both days): “Expert Workshop on Monoclonal Antibodies for AMR Pathogens” sponsored by the Paul-Ehrlich-Institut, on behalf of the COMBINE project. Day 1 focuses on preclinical development and translation (register here); Day 2 focuses on recurring problems and mitigation strategies in the clinical development (register here).
  • 16-18 June 2022 (Perth, Australia): Australasian Society for Infectious Diseases Annual Scientific Meeting is a hybrid event for adult and pediatric infectious disease and clinical microbiology specialists. Go here for details.
  • 21 Jun 2022 (virtual, 10:00-11:00 ET | 15:00-16:00 BST): Launch of the AMR Register. Sponsored by Vivli with funding from many partners, this is the launch of an open-access repository for industry-generated surveillance data. Looks interesting! Go here to register.
  • 22-23 Jun 2022 (virtual, 10a to approx. 2.30p ET on both days): Workshop entitled “Strategies for Early-Stage Programs Developing Novel Antibacterial and Antifungal Drugs.” Sponsored by NIAID’s Bacteriology and Mycology Branch (BMB), this 2-day webinar features a very strong faculty (including speakers from FDA) discussing tips and insights for early product discovery including in-depth discussions of funding opportunities. The timing is US-centered but video replay will be available. Do not miss this! Go here to register.
  • 11-14 July 2022 (Sydney): Australian Society for Microbiology Annual National Meeting is a hybrid event that will feature a range of lectures and symposium sessions, as well as extensive opportunities for networking. Go here for details.
  • 24-27 July 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.
  • 28-31 July 2022 (Singapore): 10th International Congress of Asia Pacific Society of Infection Control is a hybrid event for professionals in the Asia Pacific region. Go here for details and to register.
  • 12-13 Sep 2022 (virtual, 9a-5p ET): This meeting of PACCARB is going to “identify key issues and critical policy gaps through a series of facilitated discussions examining a hypothetical large-scale disease outbreak scenario based on historic examples and estimates of future AMR outbreaks.” Sounds like pandemic wargaming (Center for Health Security; pre-COVID 19 May 2020 NPR article) to me! Go here for details.
  • 20-24 Sep 2022 (New Delhi): 21st Congress of the International Society for Human and Animal Mycology (ISHAM). Go here for details.
  • 4-7 Oct 2022 (Dublin, Ireland): The 2022 ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This is an excellent meeting, especially for developers … and if you’ve missed it, the recordings from the 2021 meeting are online. Go here for details on the 2022 meeting.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
  • 15-23 Oct 2022 (in person, residential, Les Pensières, Veyrier-du-Lac, France): The 6th edition of Patrice Courvalin’s fabulous ICARe residential training course covering all things AMR is on for 2022! This is a soup-to-nuts training in AMR: it is very intense, very detailed, and always gets rave reviews from attendees. Registration is open 21 Mar 2022 to 21 June 2022 and is limited, so book your slot as soon as you can. Go here for details.
  • 19-23 Oct 2022 (Washington, DC): IDWeek 2022, the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Go here for details.
  • 25-28 Oct 2022 (Stellenbosch, South Africa): The University of Cape Town’s H3D Research Centre will celebrate its 10th anniversary with a symposium covering the Centre’s research on Malaria, TB, Neglected Tropical Diseases, and AMR. Go here to register.
  • 17-20 Nov 2022 (Kuala Lumpur, Malaysia): The International Congress on Infectious Diseases will take place for the first time as a hybrid event. Go here for details. 
  • 27-30 Nov 2022 (Perth, Australia): 32nd International Congress of Antimicrobial Chemotherapy is the biennial congress of the International Society of Antimicrobial Chemotherapy (ISAC). Go here for details.

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