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WHO Antibacterial Pipeline Review: Update thru 31 Dec 2023

Dear All,

WHO have released an update through 31 Dec 2023 of their ongoing series of antibacterial pipeline reviews! Here are the links you need:

  • 23 Oct 2024 addendum: There is also a summary of the report by Melchiorri et al. that is accompanied by an editorial in Lancet Microbe. The published summary in Lancet Microbe is noteworthy for a nice graphic showing how the pipeline has shifted towards Gram-negative agents from 2017 (the year of the first WHO priority pathogen list) to 2023:

Above: Figure 2 from Melchiorri et al.

As with prior reviews, this report offers an in-depth analysis of all products in development. Key findings as summarized in the press release:

  • “The current clinical antibacterial pipeline contains 97 antibacterial agents, of these, 57 are antibiotics and 40 are non-traditional agents. 
  • “Of the 57 antibiotics, 32 are intended against priority pathogens from the BPPL but only 12 can be considered innovative.
  • “Furthermore, just 4 of these 12 (innovative antibiotics) are active against at least 1 WHO ‘critical’ pathogen.
  • “Forty-seven per cent of traditional antibiotics (15/32) are β-lactam/BLI combinations with a major gap in activity against MBL producers.
  • “The preclinical pipeline is active and innovative, with many non-traditional approaches, as part of a stable number of preclinical candidates over the last 4 years. Its focus remains Gram-negative pathogens and the shift towards antibacterial agents targeting a single pathogen appears to have plateaued. 
  • “New marketing authorizations include the first authorized microbiome-modulating agents. These three non-traditional agents are all faecal-based products to prevent recurrent CDIs.”

Overall, this is an upward trend in the number of agents in development:


But, the number of agents for the high-end priority pathogens (e.g., the MBLs) remains frighteningly small. For more on this, see David Paterson excellent recent review of anti-Gram-negative agents in clinical development (https://pubmed.ncbi.nlm.nih.gov/38445383/).

In addition, the number of oral traditional antibacterial products fell from 47% in 2017 to 37.5% in 2023. This is very frustrating, as oral products are such powerful tools for enabling lower cost care.

It is interesting to note the continued interest non-traditional approaches. These are intriguing but those who wish to pursue this area should review the concerns in the 6 Aug 2019 newsletter entitled “Non-Traditional Antibiotics: A Pipeline Review And An Analysis Of Key Development Challenges.” Developing non-traditional products that are add-on products (rather than standalone products) is MUCH harder than you might expect … it is important to know the issues! 

Based on these summaries, you will not be surprised by the report’s sobering main conclusion: “Overall, antibacterial agents in the clinical pipeline combined with those approved in the last six years are still insufficient to tackle the ever growing threat of the emergence and spread of drug-resistant infections.”

Yup, that’s it in a nutshell … we don’t (yet) have the drugs we need and antibacterial R&D is very, very challenging … it’s hard to find them, it’s hard (and slow!) to develop them, and the people who know how to develop them are exiting the field:


Deep sigh … this is such a threat to all of modern healthcare. As summarized by the recent series in Lancet (newsletter, video tour of same), we urgently need sustainable access to new and existing antibiotics and diagnostics. And the path to achieving this is now clear with our most fundamental remaining gap being the need for adequate Pull incentives! The UK model has shown us how … and now it is time for global action on other Pull incentives that will drive innovation such as the PASTEUR Act in the US, the proposed TEV-based Pull from the European Commission as well as the ideas on Pull from Switzerland, Canada, and Japan.

Well, that’s enough Doom and Gloom for today … the good news is that there are products in development … fingers crossed! With thanks to all who are dedicating their time and energy to this challenge, –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

  • [NEW] The GHIT Fund have released calls for collaborations between Japanese and non-Japanese companes for “drugs, vaccines and diagnostics for infectious diseases prevalent in developing countries” (RFP-PD-2024-002) and “technologies and approaches that address unmet or priority needs within malaria, tuberculosis (TB) and Neglected Tropical Diseases (NTDs)” (RFP-TRP-2024-002). Both calls support projects of up to 2 years in length have an 11 July 2024 deadline for submission of an Intent to Apply. 
  • [NEW] Vivli has announced the 2024 Vivli AMR Surveillance Data Challenge. This particular challenge is funded by GARDP, Paratek, Pfizer and Vivli and aims to encourage and support the innovative re-use of surveillance data shared by GSK, Johnson & Johnson, Pfizer, Shionogi, Paratek and Venatorx that are now available in the Vivli AMR Register. This is 2nd AMR data challenge from Vivli — see the 20 Oct 2023 newsletter for a discussion of the outcome of this first challenge. This 2nd challenge offers monetary prizes, including travel funding to attend ESCMID Global or ASM Microbe in 2025 (if an abstract is accepted), and a new AMR Student Innovation Award. The deadline for expressions of interest is 28 July 2024. For more details, go here. 
  • [NEW] The AMR Industry Alliance have announced the 2024 edition of their ongoing annual series of stewardship prizes. Applications for innovative approaches to AMR stewardship are sought from public, private or not-for-profit health care organization or institution operating in an LMIC. This year’s deadline is 1 Sep 2024. Go here for details.
  • Environmental AMR issues, anyone? ICARS has call open through 1 Aug 2024 for “projects in the public health sphere that aim to mitigate the evolution and transmission of resistance in the natural or built environment.” Grants are available of up to $800k for up to 4 years. Go here for details; for questions and submissions, write to RFP_EDAR@icars-global.org. Applicants should also refer to “Mitigating antimicrobial resistance (AMR) using implementation research: a development funder’s approach” from JAC 2023 (https://doi.org/10.1093/jacamr/dlad031).
  • CARB-X has open calls that span four areas: (i) Therapeutics for Gram-Negatives, (ii) Prevention for Invasive Disease, (iii) Diagnostics for Neonatal Sepsis, and (iv) Proof-Of-Concept for Diagnosing Lower-Respiratory-Tract Infections. See this 6 Mar 2024 newsletter for a discussion of the call and go here for the CARB-X webpage on the call. There are multiple opportunities to submit — see the CARB-X webpage for details.
  • BARDA’s long-running BAA (Broad Agency Announcement) for medical countermeasures (MCMs) for chemical, biological, radiological, and nuclear (CBRN) threats, pandemic influenza, and emerging infectious diseases is now BAA-23-100-SOL-00004 and offers support for both antibacterial and antifungal agents (as well as antivirals, antitoxins, diagnostics, and more). Note especially these Areas of Interest: Area 3.1 (MDR Bacteria and Biothreat Pathogens), Area 3.2 (MDR Fungal Infections), and Area 7.2 (Antibiotic Resistance Diagnostics for Priority Bacterial Pathogens). Although prior BAAs used a rolling cycle of 4 deadlines/year, the updated BAA released 26 Sep 2023 has a 5-year application period that ends 25 Sep 2028 and is open to applicants regardless of location: BARDA seeks the best science from anywhere in the world! See also this newsletter for further comments on the BAA and its areas of interest.
  • HERA Invest was launched August 2023 with €100 million to support innovative EU-based SMEs in the early and late phases of clinical trials. Part of the InvestEU program supporting sustainable investment, innovation, and job creation in Europe, HERA Invest is open for application to companies developing medical countermeasures that address one of the following cross-border health threats: (i) Pathogens with pandemic or epidemic potential, (ii) Chemical, biological, radiological and nuclear (CBRN) threats originating from accidental or deliberate release, and (iii) Antimicrobial resistance (AMR). Non-dilutive venture loans covering up to 50% of investment costs are available. A closing date is not posted insofar as I can see — applications are accepted on a rolling basis; go here for more details.
  • The AMR Action Fund is open on an ongoing basis 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 an early-stage funding vehicle supporting innovation vs. drug-resistant bacterial infections. The fund provides advice, community, and non-dilutive funding (€10k in Stage I and up to €250k in Stage II) to support early-stage ventures in creating the evidence and building the team needed to get next-level funding. Details and contacts on their website (https://www.incate.net/).
  • These things aren’t sources of funds but would help you develop funding applications
    • 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.
    • Diagnostic developers would find valuable guidance in this 6-part series on in vitro diagnostic (IVD) development. Sponsored by CARB-X, C-CAMP, and FIND, it pulls together real-life insights into a succinct set of tutorials.
  • 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).


John’s Top Recurring Meetings
Virtual meetings are easy to attend, but regular attendance at annual in-person events is the key to building your network and gaining deeper insight. My personal favorites for such in-person meetings are below. Of particular value for developers are the AMR Conference and the ASM-ESCMID conference. Hope to see you there!

  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. Go here to register!
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. Save the date! More details to come!
  • 25-26 February 2025 (Basel, Switzerland): The 9th AMR Conference 2025. Go here to register! 
  • 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. Go here for details. 

 

Upcoming meetings of interest to the AMR community:

  • 13-17 June 2024 (Atlanta, Georgia): ASM Microbe, the annual meeting of the American Society for Microbiology. You can’t register yet, but you can go here for general details.
  • 27 June 2024 (virtual, 5p-630p CEST): GARDP REVIVE Webinar “Progressing an antibacterial drug discovery project – an SME perspective.” Click here for details and to register.
  • [NEW] 22 Aug 2024 (virtual, 5p-630p CEST): GARDP REVIVE Webinar “Exploring non-traditional antimicrobials: Insights from three cases.” Go here for details and to register. If non-traditional approaches interest you, please do be sure to review the challenges that are raised in the papers discussed in the 6 Aug 2019 newsletter entitled “Non-Traditional Antibiotics: A Pipeline Review And An Analysis Of Key Development Challenges.” Developing non-traditional products is MUCH harder than you might expect … it is important to know the issues!
  • 17-20 Sep 2024 (Porto, Portugal): ASM/ESCMID Joint Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. See Recurring Meetings list, above.
  • 16-20 Oct 2024 (Los Angeles, USA): IDWeek 2024, the annual meeting of the Infectious Diseases Society of America. See Recurring Meetings list, above. 
  • 19-27 Oct 2024 (Annecy, France, residential in-person program): ICARe (Interdisciplinary Course on Antibiotics and Resistance). Now in its 8th year, Patrice Courvalin directs the program with the support of an all-star scientific committee and faculty. The resulting soup-to-nuts training covers all aspects of antimicrobials, is very intense, and routinely gets rave reviews! Seating is limited, so mark your calendars now if you are interested. Applications open in March 2024 — go here for more details.
  • 4-5 Dec 2024 (in person, Washington, DC): “Fungal Dx 2024: Fungal Diagnostics in Clinical Practice” is a 2-day in-person workshop organized by ISHAM‘s Fungal Diagnostics Working Group. The program and registration links are available at https://fungaldx.com/; the agenda is comprehensive and features an all-star global list of speakers.
  • 11-15 April 2025 (Vienna, Austria): ESCMID Global 2025, the annual meeting of the European Society for Clinical Microbiology and Infectious Diseases. See Recurring Meetings list, above.
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