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Anti-Infectives Development for National Institutes of Health
SRI is conducting preclinical development of treatments for diseases such as tuberculosis, West Nile virus, hepatitis, and biodefense pathogens and toxins.
Since 2006, researchers in SRI Biosciences have supported the development of drugs for the treatment of a broad range of infectious diseases, including tuberculosis, malaria, biodefense agents, hepatitis, influenza, SARS, West Nile disease, toxins, and diseases of developing nations (e.g., Chagas disease and Ebola). SRI works closely with program managers at the National Institute of Allergy and Infectious Diseases (NIAID) Division of Microbiology and Infectious Disease (DMID), with academic investigators, and at small and large companies to advance promising therapeutics for the treatment of infectious diseases. Much of the work is carried out under Good Laboratory Practice (GLP) and current Good Manufacturing Practice (cGMP) regulations.
Support crosses the entire spectrum of development services, including lead optimization, chemical synthesis, pharmacokinetics and metabolism, safety studies, formulation design, GMP drug synthesis, GMP clinical manufacturing, and development of regulatory and program planning documents. Since the program’s inception, SRI has conducted more than 100 different development programs under this contract.
Examples of tasks either completed or ongoing include:
- Synthesis of 250 chemical analogs in a promising compound scaffold against influenza
- Predictive absorption, distribution, metabolism, and excretion (ADMET) studies on approximately 160 compound candidates against TB or biodefense pathogens to identify the most “druggable” molecules
- A full preclinical development program for a new drug to treat Chagas disease. Tasks include synthesis, safety, pharmacokinetics, formulation design, and GMP drug synthesis.
- Clinical manufacturing and analytical chemistry support for the treatment of “Valley Fever” (Coccidiomycosis), a rare systemic fungal disease
- Safety studies of a new monoclonal antibody cocktail against botulinum toxin
- The development of a novel formulation of a drug used to treat hookworm
- Full preclinical safety and pharmacokinetics studies of a drug to treat hepatitis C, polio, and methicillin-resistant Staphylococcus aureus (MRSA)
- Reproductive toxicity studies (Segment I and II) of a drug currently being evaluated in Phase II clinical trials against TB
- Development of a novel oral formulation of vancomycin
This project will be been funded in whole with Federal funds up to $100.5 million over 10 years from the National institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN2722011000221.