National Institute of Allergy and Infectious Diseases (NIAID) has released a new Broad Agency Announcement (BAA) in support of the development of candidate therapeutic products for use in post-event settings following the intentional release of Category A, B, and C biothreat agents or in response to naturally occurring outbreaks of infectious diseases caused by pathogens in the same category.
The funding opportunity specifically focuses on the development of promising biodefense therapeutic products with broad spectrum therapeutic activity, enabling mitigation of biological threats across a wide range or class of agents. There are a number of traditional threats for which effective treatments are either non-existent, of limited usefulness, or vulnerable to both naturally emerging and intentionally engineered antibacterial and antiviral resistance.
“A limited number of anti-infectives with broad spectrum activity directed at common, invariable, and essential components of different classes of microbes could potentially be effective against both traditional and non-traditional threats,” states the announcement. “This approach would allow a small number of drugs to replace dozens of pathogen-specific drugs for emergency use.”
Agents of interest for broad-spectrum anti-bacterials include: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Burkholderia pseudomallei, B. mallei, and Rickettsia prowazekii. For anti-virals, the target pathogens include: Ebola virus, Marburg virus, Variola major, Dengue virus, Venezuelan encephalitis virus, Western Equine encephalitis virus, Eastern Equine encephalitis virus and human influenza virus.
Strategies to overcome bacterial and viral drug resistance could have immediate public health benefits of extending the utility of existing broad spectrum anti-infectives. Similarly, developing targeted immune response mechanisms could provide clinical utility when used alone or in combination with conventional anti-infectives.
The solicitation also focuses on development of promising anti-toxins as biodefense therapeutic candidates, particularly small molecule therapeutics with anti-toxin activity. While bacteria that produce toxins may often be eliminated by the use of antibiotics, disease may still occur or may progress because of the presence of toxins produced by the pathogen. Targets supported under this effort include: Botulinum neurotoxin, Staphylococcus enterotoxin B, Bacillus anthracis Protective Antigen, Lethal Factor or Edema Factor, and ricin toxin.
The activities supported through the BAA will allow candidate therapeutic countermeasures to progress through the product development pipeline toward licensure by the FDA with the eventual goal of stockpiling these medical countermeasures and associated technologies.
Full details are available under Solicitation Number: BAA-NIAID-DMID-NIHAI2012149. The response deadline is October 1, 2012.
