Below is the text that Infex Therapeutics submitted to the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) ahead of its 27th public meeting on June 16th:

INFEX Therapeutics is delighted to hear that the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria (PACCARB) is reconvening. We very much supported the 2024 report and the four priorities championed within that, which we will comment on later in this submission.

INFEX Therapeutics is a clinical stage research and development company, based in Cheshire in the United Kingdom, with multiple global industry and academic partnerships. INFEX has a pipeline of innovative clinical and preclinical programs targeting Pseudomonas aeruginosa infections in patients with chronic lung disease, metallo--lactamase producing antibiotic resistant Gram-negative infections and viral infections with pandemic potential, encompassing a mix of traditional and non-traditional approaches.

INFEX is also part of the BEAM Alliance, which is a European group of over sixty small and medium enterprises (SMEs) involved in antimicrobial research. BEAM is very active in Europe and Globally lobbying for sustainable antimicrobial development and has been very effective at building global links and partnerships. The BEAM alliance had a significant role in facilitating the European Union’s decision to introduce pull incentives in 2026, initially with transferable exclusivity vouchers, and with a commitment to work towards an antimicrobial subscription model.
INFEX Therapeutics has had funding from NIAID and BARDA and continuation of these funding mechanisms is vital to help combat antimicrobial resistance (AMR). In addition, INFEX team members, (Prof Colm Leonard as NICE clinical lead, and Dr Peter Jackson as a member of the expert advisory panel) had key roles in influencing the UK antimicrobial subscription model pilot project in 2022, a World first delinked payment model to support new antimicrobial development. INFEX are happy to offer our service and input to US initiatives.

The 2024 PACCARB Global AMR Working Group report identified four key priorities:
1. Preventing infection
2. Increasing awareness of antimicrobial resistance to drive global action
3. Globally responsive development of products and solutions to combat antimicrobial resistance
4. Equitable access to antimicrobials. vaccines and diagnostics,

INFEX strongly support priority three of the 2024 PACCARB report, which highlighted the importance of supporting development of innovative products to address antimicrobial resistance, both relevant to the US market and also globally. Recommendation three, based on priority three of the 2024 report emphasized the key importance of advancing global market-based incentives to build and sustain development of new products that address antimicrobial resistance, including diagnostics and therapeutics, based on domestic and global need. The US specific recommendation for this priority also emphasized implementing domestic policies that support market-based incentives for product development to demonstrate their effectiveness and reward innovation, while supporting programs that pilot similar incentive models in partner countries.

From our perspective as an SME, a key next step that we would encourage PACCARB to prioritise would be championing the passing of the Pasteur Act by the United States Government which would be a game changing ‘pull incentive’ that would dramatically improve the sustainability of antimicrobial development. We would also encourage PACCARB to continue to support funding agencies like CARB-X and BARDA, which have had an enormous positive impact on the early development pipeline. However, while the early pipeline is now in a healthier state, companies bringing new antimicrobials to market still face an enormous cliff edge of inadequate reimbursement which threatens their survival. Pull incentives within the Pasteur Act are crucial to create a sustainable market for novel antimicrobials and are a logical follow-on from the UK antimicrobial subscription model, which delivered its initial pilot pull incentive in 2022, with a standard process now in place to deliver subscription contracts for novel antimicrobials. And, of course, this year the European Union plans to implement pull incentives with the introduction of transferable exclusivity vouchers and will follow this with a subscription model.

INFEX encourage further regulatory reform. While of course welcoming the ongoing efforts by the FDA to support a more streamlined regulatory process for antimicrobial development, for example the recent support for Bayesian adaptive trial design, and the licensing of Durlobactam-Sulbactam which was based on one small pivotal trial. But we also think that further regulatory changes are very important including the following;
– Increased global regulatory collaboration and harmonization of global regulatory processes across global regulatory agencies (FDA, EMA, PDMA) to reduce delays in market access for new antimicrobials. This relates to priority 4 of the 2024 PACCARB report which champions ‘equitable access to antimicrobials, vaccines and diagnostics’.
– Proactive efforts by FDA to work with antimicrobial developers on how to best facilitate non-traditional approaches to tackling AMR

INFEX also encourages further efforts by PACCARB in the area of antimicrobial diagnostics. Bacteria and viruses are capable of constantly evolving to evade antimicrobials and anti-virals. Having point of care access to accurate, fast and affordable diagnostics is vital to ensuring appropriate use of antimicrobials and antivirals. Having the right drug at the right time ensures appropriate treatment for the patient and optimises stewardship of our existing antimicrobial and antiviral agents. But there are a number of factors which do not support optimal use of diagnostics;
1. Inadequate evidence base to support cost-effectiveness evaluation
2. Optimal methodology to evaluate cost-effectiveness has yet to be defined
3. Lack of appropriate reimbursement for novel diagnostics and risk of market failure
4. Regulatory hurdles

We encourage PACCARB to highlight the need for collaboration between funders of diagnostic research, academia, BioTech industry, regulators, and health system payers to work on ways to better encourage a sustainable pipeline of diagnostics and appropriate evaluation, reimbursement and implementation of these vital tools in the fight against AMR.