Nontraditional Products for Bacterial Infections in Clinical Development
As of September 2017, an estimated 32 new nontraditional products1 with the potential to treat or prevent serious bacterial infections are in clinical development. Below is a snapshot of the current nontraditional products pipeline, based on publicly available information and informed by external experts. It is updated periodically as products advance or are known to drop out of development. Because this list is updated periodically, endnote numbers may not be sequential.
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- Development Phase
Note: The following drugs have been removed from the pipeline. They will be included in future updates if development resumes:
- September 2017: Cdiffense and Shigamab were removed during the September 2017 review because they were no longer included in the research and development pipeline on the company's website or
discontinuation of development was announced through a company press release.
- Products listed here contain at least one component not previously approved in the United States. This pipeline is limited to products with the potential to treat or prevent infections caused by bacterial pathogens considered by the Centers for Disease Control and Prevention to be urgent, serious, or concerning threats (CDC, “Antibiotic Resistance Threats in the United States, 2013,” Sept. 16, 2013, https://www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf). All analyses were limited to systemic products (drugs that work throughout the body) and therapies to treat Clostridium difficile-associated disease. We excluded drugs to treat mycobacterial infections, such as tuberculosis and Mycobacterium avium complex, Helicobacter pylori, and biothreat pathogens. Also excluded were locally acting therapies such as topical, ophthalmic, and inhaled products. Many of these products probably will not be used as a stand-alone treatment, but as an adjunctive to standard-of-care antibiotics.
- Based on the most advanced development phase for any indication according to trials registered in http://www.clinicaltrials.gov, unless direct communication from the company indicated differently. If no trials were included in clinicaltrials.gov, the phase listed on the company website or provided directly by the company is noted.
- Based on clinical trials currently registered in http://www.clinicaltrials.gov unless otherwise noted.
- Registered in http://www.clinicaltrials.gov but with no current study sites within the United States.
- Ribaxamase is a β-lactamase, which is given orally and prophylactically with an IV antibiotic. Ribaxamase degrades antibiotics in the GI tract to minimize collateral damage to the gut microbiome and prevent occurrence of C. difficile.
- In these clinical trials, the Group B Streptococcus vaccine is administered to pregnant women with the goal of preventing streptococcal infections in newborns.
- Not currently registered on http://www.clinicaltrials.gov. Information obtained from the company via a corporate website, news release, and/or direct company communication.
- Vaccines for S. pneumoniae have been approved and widely used. The products in development listed in this table have the potential for expanded serotype coverage.
Because the conventional antibiotics pipeline remains so thin, finding new approaches is critical