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Symbiotic-based discovery for a safe selective antifungal therapy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI134541-01A1
Agency Tracking Number: R43AI134541
Amount: $150,000.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA17-302
Solicitation Year: 2017
Award Year: 2018
Award Start Date (Proposal Award Date): 2018-04-19
Award End Date (Contract End Date): 2019-03-30
Small Business Information
Schenectady, NY 12305-2504
United States
DUNS: 080486862
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (518) 641-6410
Business Contact
Phone: (518) 631-8101
Research Institution

Project Summary
Antimicrobial innovation has slowed to a crawl while an epidemic of antimicrobial resistant infections surgesthreatening the public healthThe overarching goal of this project is to develop a novel natural product
antifungalselvamicintargeting drug resistant fungal infectionsThis molecule was identified from a symbiotic
animal environmentGrowing evidence suggests this is a rich and untapped source of novel compoundsMore importantlythe molecules from these symbiotic environments exhibit an extremely high rate of both
biological activity and animal safetypresumably due to the evolutionary selection of the symbiotic relationship
between the antibiotic producing microbe and animalConsistent with this hypothesispreliminary data with
selvamicin demonstrates promising broad spectrum activity against drug resistant fungi in vitro and in pilot
animal studies coupled with the absence of a toxicity signal from early cell and whole animal drug exposure
studiesThe proposed Phasestudies will further explore the feasibility for clinical development of this lead
antifungal via three IND enabling aimsAimsandwill expand preclinical efficacypharmacokineticand
toxicology investigationAimwill focus on scale up compound production and physiochemical
characterization needed for subsequent GLP production required for Phasetoxicology analysis and early
human studiesThe milestones for success will clearly discern the therapeutic potential of selvamicin by
defining the the murine PK PD target in standard FDA utilized modelsthe safety and therapeutic window for
standard end organsand advance production and chemical analysis toward GLP GMP capacity for Phasedevelopment Relevance
There are no effective therapies for the emerging resistant fungal pathogens that are becoming an increasing
threat to the public healthThe goals of this Phaseproject are to further develop a drug from a promising
new antifungal class to address this unmet clinical need for growing immunocompromised patient populations

* Information listed above is at the time of submission. *

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