Current antibacterial pipeline “insufficient” to meet the threat of AMR, policy reforms critically needed
The Biotechnology Innovation Organization (BIO), has released a new report examining antibacterial innovation and the current pipeline for new antibacterial medicines, The State of Innovation in Antibacterial Therapeutics. The report analyzes the pipeline for new antibacterial medicines, the market’s unique investment challenges and potential policy solutions to support the development of new treatments.
“Over 1 million people worldwide lost their lives to drug-resistant bacteria in 2019. We urgently need new, effective antimicrobial medicines to keep up with ever-growing resistance,” said Dr. Michelle McMurry-Heath, President and CEO of BIO. “This new report illuminates the unfortunate reality of the antimicrobial market and why policymakers should act now to help address its unique challenges and support innovation.”
The report, authored by David Thomas and Chad Wessel of BIO’s Industry Analysis team, includes several key takeaways for the current state of antibacterial innovation:
- Approved Antibacterial Drugs: Although there have been 164 FDA-approved direct-acting antibacterial new chemical entities (NCEs) since the early 1900s, only one new molecular target NCE has been approved over the last 35 years, illustrating a need to broaden the antibacterial discovery engine. There have been 11 indirect-acting NCEs approved, including seven drugs that work to extend the activity of existing drugs and four monoclonal antibodies specific for exotoxins.
- Pipeline: The breadth and novelty of the antibacterial clinical-stage pipeline is insufficient to meet the ongoing threat of wide-spread infection from drug-resistant strains. The clinical pipeline contains 54 direct-acting novel chemical or biochemical entities and 10 microbial entities. However, of the non-microbial candidates, 61% have targets for which marketed drugs already exist. More than 38% of candidate programs are indicated for C. difficile and TB, leaving only 44 drugs for other pathogenic bacteria. Only 10 of these 44 candidates have a novel target. There have been 14 indirect-acting NCEs in the clinical pipeline, including nine that work to extend the activity of existing drugs and five monoclonal antibodies specific for exotoxins.
- Emerging Company Contribution to Innovation: Small companies discovered 81% of the antibacterial therapeutics being tested in the clinic. Large biopharmaceutical companies discovered 12%, and small non-profit organizations discovered 7% of the antibacterial therapeutics being tested in the clinic.
- Clinical Trial Success Rates: The calculated success rate from Phase I to FDA approval during the period 2011-2020 was 16.3% for an antibacterial NCE. This is more than twice the overall industry success rate of 7.9%. For novel targeting NCEs, the success rate was 13%, with only three novel target drug programs transitioning at Phase III during this ten-year period.
- Emerging Company Investment: Venture capital funding of U.S. antibacterial-focused biopharma over the last decade was $1.6 billion compared to oncology’s $26.5 billion. IPOs for 12 U.S. antibacterial-focused biopharma brought in just $0.7 billion over this period, compared to 109 U.S. oncology companies raising $12 billion. This equates to almost 17x less funding of antibacterial vs. oncology companies during this time.
- Clinical Trial Initiations: Clinical trial initiations for antibacterial NCEs declined 33% when comparing the five-year period 2016-2020 vs. 2011-2015.
- Potential solutions to strengthen the antibacterial pipeline: 1) Early-stage investment (push mechanisms for research), 2) regulatory incentives, 3) late-stage investment (push mechanisms for development), 4) market-based mechanisms (pull incentives), and 5) reimbursement reform.
“Overall, we found low and waning investment resulting in a narrowly focused, thin pipeline for antibacterials,” said David Thomas, CFA, Vice President for Industry Research at BIO. “Robust innovation in this space is absolutely critical to tackling the global threat of antimicrobial resistance and we believe public policy solutions are necessary to realign market incentives and encourage more innovation.”
The report and other BIO Industry Analysis reports are available for download at www.bio.org/iareports.
