SBIR-STTR Award

Development of a Novel Product for Skin Decontamination After Exposure to Chemical Warfare Agents
Award last edited on: 2/19/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$2,079,857
Award Phase
2
Solicitation Topic Code
853
Principal Investigator
Scott Noblitt

Company Information

Armis Biopharma Inc

2950 East Harmony Road Suite 252
Fort Collins, CO 80528
   (970) 266-5127
   info@armisbiopharma.com
   www.armisbiopharma.com
Location: Single
Congr. District: 02
County: Larimer

Phase I

Contract Number: 1R44NS119085-01
Start Date: 9/15/2020    Completed: 2/28/2022
Phase I year
2020
Phase I Amount
$423,048
With the increasing threat of terrorism, the development of countermeasures for the event of a chemical attack on civilians has become a high priority. Mass casualty events in which chemical warfare agents (CWA) would be employed in an attack on a civilian population, are a concrete risk. Because of significant differences between members of the military and civilians, existing countermeasures may need to be adapted or expanded for use in a civilian population. This project proposes the development of Veriox®, a proprietary formulation, to provide first responders working on mass-casualty decontamination (DC) an inexpensive, FDA approved, fast-acting, field- deployable skin decontamination kit that would provide superior levels of protection when compared to the current field-deployed products. Veriox® offers several advantages over existing DC products for mass casualty settings, because it can be rapidly dispensed with standard liquid dispensing systems (hand operated sprayers and mass casualty shower systems) that will allow first responders to quickly decontaminate multiple individuals. Last but not least, since Veriox® breaks down rapidly into harmless products, it demonstrates a better safety and toxicity profile, and is also environmentally safe. While Veriox® is a potentially broad-spectrum decontaminant, with efficacy shown already against Generating Antibiotic Incentives Now (GAIN) Act pathogens, this project focuses on its development in the context of nerve agent decontamination. We present a strong background of preliminary studies demonstrating efficacy in vivo. The next step of the development program is to demonstrate safety of the product in animals which will then enable advancement of the product into human testing. This is the focus of the present grant.

Public Health Relevance Statement:
NARRATIVE With the increasing threat of terrorism, the development of countermeasures for the event of a chemical attack on civilians has become a high priority. This grant focuses on the development of a skin decontamination product to be used by first responders in case of a suspected nerve agent attack.

Project Terms:
Acetic Acids; Animals; Antibiotics; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Chemical Warfare; chemical attack; Chemical Warfare Agents; chemical warfare substances; Decontamination; Equilibrium; balance; balance function; Future; Grant; Hand; Human; Modern Man; Incentives; Lead; Pb element; heavy metal Pb; heavy metal lead; Methods; Methodology; Military Personnel; Armed Forces Personnel; Military; Oxygen; O element; O2 element; Clinical Pathology; Peracetic Acid; Acetyl Hydroperoxide; Ethaneperoxoic acid; Peroxyacetic Acid; Peroxyethanoic Acid; Pilot Projects; pilot study; Production; Program Development; Rattus; Common Rat Strains; Rat; Rats Mammals; Research Design; Study Type; study design; Research Institute; Risk; Rodent; Rodentia; Rodents Mammals; Safety; Miniature Swine; Minipigs; mini pig; mini-swine; miniswine; Temperature; Terrorism; terrorist attack; Testing; Water; Hydrogen Oxide; Measures; Medical Research; Guinea Pigs; Guinea Pigs Mammals; Cavia; Procedures; Site; Phase; Series; Chemicals; Dermal; Individual; Toxicokinetics; fluid; liquid; Liquid substance; Exposure to; Event; irritation; System; interest; Toxicities; Toxic effect; Histopathology; novel; member; Adverse effects; nerve agent; Skin; Decontamination Agent; Decontaminant; Dose; Department of Defense; in vivo; developmental; Development; safety study; pathogen; Population; FDA approved; mass casualty; Formulation; systemic toxicity; first responder

Phase II

Contract Number: 5R44NS119085-02
Start Date: 9/15/2020    Completed: 2/28/2022
Phase II year
2021
(last award dollars: 2023)
Phase II Amount
$1,656,809

With the increasing threat of terrorism, the development of countermeasures for the event of a chemical attack on civilians has become a high priority. Mass casualty events in which chemical warfare agents (CWA) would be employed in an attack on a civilian population, are a concrete risk. Because of significant differences between members of the military and civilians, existing countermeasures may need to be adapted or expanded for use in a civilian population. This project proposes the development of Veriox®, a proprietary formulation, to provide first responders working on mass-casualty decontamination (DC) an inexpensive, FDA approved, fast-acting, field- deployable skin decontamination kit that would provide superior levels of protection when compared to the current field-deployed products. Veriox® offers several advantages over existing DC products for mass casualty settings, because it can be rapidly dispensed with standard liquid dispensing systems (hand operated sprayers and mass casualty shower systems) that will allow first responders to quickly decontaminate multiple individuals. Last but not least, since Veriox® breaks down rapidly into harmless products, it demonstrates a better safety and toxicity profile, and is also environmentally safe. While Veriox® is a potentially broad-spectrum decontaminant, with efficacy shown already against Generating Antibiotic Incentives Now (GAIN) Act pathogens, this project focuses on its development in the context of nerve agent decontamination. We present a strong background of preliminary studies demonstrating efficacy in vivo. The next step of the development program is to demonstrate safety of the product in animals which will then enable advancement of the product into human testing. This is the focus of the present grant.

Public Health Relevance Statement:
NARRATIVE With the increasing threat of terrorism, the development of countermeasures for the event of a chemical attack on civilians has become a high priority. This grant focuses on the development of a skin decontamination product to be used by first responders in case of a suspected nerve agent attack.

Project Terms:
Acetic Acids; Animals; Antibiotics; Antibiotic Agents; Antibiotic Drugs; Miscellaneous Antibiotic; Chemical Warfare; chemical attack; Chemical Warfare Agents; chemical warfare substances; Decontamination; Equilibrium; balance; balance function; Future; Grant; Hand; Human; Modern Man; Incentives; Lead; Pb element; heavy metal Pb; heavy metal lead; Methods; Methodology; Oxygen; O element; O2 element; Clinical Pathology; Peracetic Acid; Acetyl Hydroperoxide; Ethaneperoxoic acid; Peroxyacetic Acid; Peroxyethanoic Acid; Pilot Projects; pilot study; Production; Program Development; Rattus; Common Rat Strains; Rat; Rats Mammals; Research Design; Study Type; study design; Research Institute; Risk; Rodent; Rodentia; Rodents Mammals; Safety; Miniature Swine; Minipigs; mini pig; mini-swine; miniswine; Temperature; Terrorism; terrorist attack; Testing; Water; Hydrogen Oxide; Measures; Medical Research; Cavia; Guinea Pigs; Guinea Pigs Mammals; Procedures; Site; Phase; Series; Chemicals; Dermal; Individual; Toxicokinetics; fluid; liquid; Liquid substance; Exposure to; Event; irritation; System; interest; Toxicities; Toxic effect; Histopathology; novel; Adverse effects; nerve agent; Skin; Decontamination Agent; Decontaminant; Dose; Department of Defense; in vivo; Development; developmental; safety study; pathogen; Population; FDA approved; mass casualty; Formulation; systemic toxicity; service member; military member; first responder