New Report Examines the State of Antibacterial Innovation

The drug pipeline is insufficient to meet the threat of antimicrobial resistance, and policy reforms are critically needed, according to the Biotechnology Innovation Organization.

A new report released by the Biotechnology Innovation Organization (BIO) has analyzed antibacterial innovation and the pipeline for new antibacterial medicines and finds that there are serious challenges.

The report, titled “The State of Innovation in Antibacterial Therapeutics,” analyzes the pipeline for new antibacterial medicines, the market’s unique investment challenges, and potential policy solutions to support the development of new treatments.

The objective of the report is to help bridge the gaps in the antibacterial resource area. In previously published research on this topic, drug development investment for common chronic diseases was found to be declining and low relative to the total health care burden on society. Further, in a survey of under-funded disease areas, antibiotic investment was found to be low and not on an upward trend with the rest of the industry.

“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,” Michelle McMurry-Heath, MD, president and CEO of BIO, said in a statement.

“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,” She said.

The report includes several key takeaways on the state of antibacterial innovation. These include:

  • Approved antibacterial drugs. Although there have been 164 FDA-approved direct-acting antibacterial new chemical entities (NCEs) since the early 1900s, just 1 new molecular target NCE has been approved over the past 35 years, illustrating a need to broaden the antibacterial discovery engine. There have been 11 indirect-acting NCEs approved, including 7 drugs that work to extend the activity of existing drugs and 4 monoclonal antibodies specific for exotoxins.
  • Clinical trial initiations. Clinical trial initiations for antibacterial NCEs declined 33% between 2011 to 2015 and 2016 to 2020.
  • Clinical trial success rates. From 2011 to 2020, the calculated success rate from phase 1 to FDA approval was 16.3% for an antibacterial NCE, which is more than twice the overall industry success rate of 7.9%. For novel targeting NCEs, the success rate was 13%, with just 3 novel target drug programs transitioning at phase 3 during this 10-year period.
  • Emerging company contribution to innovation. Over the past several years, small companies discovered 81% of the antibacterial therapeutics being tested in the clinics. In addition, large biopharmaceutical companies discovered 12% and small non-profit organizations discovered 7% of the antibacterial therapeutics being tested.
  • Emerging company investment. Over the decade, venture capital funding of US antibacterial-focused biopharmaceutical companies was $1.6 billion compared with oncology’s $26.5 billion. Further, initial public offerings for 12 US antibacterial-focused biopharmaceutical companies brought in approximately $700,000 million over this period versus 109 US oncology companies raising $12 billion. This equates to almost 17 times less funding of antibacterial versus oncology companies during this time.
  • Pipeline. Although the threat of ongoing widespread infection from drug-resistant strains continues to grow, the innovation and range of the antibacterial clinical-stage pipeline is deficient. 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. Additionally, more than 38% of candidate programs are indicated for C. difficile and tuberculosis, which leaves 44 drugs for other pathogenic bacteria, with 10 of those having a novel target. There have been 14 indirect-acting NCEs in the clinical pipeline, including 9 that work to extend the activity of existing drugs and 5 monoclonal antibodies specifically for exotoxins.
  • Potential solutions to help strengthen the antibacterial pipeline include: early-stage investment, such as pushing mechanisms for research; late-stage investment, including to push mechanisms for development; market-based mechanisms to further pull incentives; reimbursement reform; and regulatory incentives.

“Overall, we found low and waning investment resulting in a narrowly focused, thin pipeline for antibacterials,” David Thomas, CFA, vice president for industry research at BIO, said in the statement. “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.”

Reference

New BIO report examines the state of antibacterial innovation. Biotechnology Innovation Organization. February 14, 2022. Accessed February 14, 2022. https://www.bio.org/press-release/new-bio-report-examines-state-antibacterial-innovation