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A Serological Assay for Neutralizing Antitoxin Response in Patients with Clostridioides difficile Infection (Phase II)

Award Number: R44AI136176
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 01/20/2018
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A Serological Assay for Neutralizing Antitoxin Response in Patients with Clostridioides difficile Infection (Phase II) - Abstract This SBIR Phase II project will support the development of an in vitro diagnostic blood test to determine whether a person infected with Clostridioides difficile has mounted enough neutralizing antitoxin antibodies so that they are unlikely to suffer recurrence. Antibiotic-resistant C. difficile is responsible for more than 29,000 deaths in the US each year and the infection is an urgent threat to public health worldwide. The current standard treatment with antibiotics disrupts gut microbiota and induces high rates of recurrence, which is the most significant issue in clinical management of the disease. C. difficile infection (CDI) is mainly caused by two major exotoxins, and toxin-neutralizing antibodies are responsible for effective immunity. However, current assays to measure patient antitoxin responses are based on cell-culture neutralizing bioassay that is time consuming, laborious, and difficult to standardize, thus such bioassay is limited in research laboratories. In our SBIR Phase I (R43AI136176) study, we successfully established a simple and rapid serological ELISA, designated as BB-ELISA, and demonstrated that the BB-ELISA was able to measure antitoxin neutralizing activities in CDI blood samples. Based on these promising results, we propose to standardize this novel BB- ELISA through an experience CRO Corgenix and to collaborate with Merck to evaluate the assay for predicting CDI disease recurrence and outcomes. The completion of this Phase II SBIR will not only validate this novel ELISA for measuring neutralizing antibody responses in CDI patients and predicting disease outcomes, but also pave the way toward future commercialization of this novel ELISA assay.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	FZATA INC	1450 S ROLLING RD	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	5/15/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $923,175 )
2023	2023	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	4	8/10/2023	NON-COMPETING CONTINUATION	$923,175
														Subtotal = $923,175

Issue Date FY: 2022 ( Subtotal = $988,488 )
2022	2022	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	3	8/11/2022	NON-COMPETING CONTINUATION	$988,488
														Subtotal = $988,488

Issue Date FY: 2021 ( Subtotal = $999,996 )
2021	2021	FZATA INC	1450 S ROLLING RD STE 4101	HALETHORPE	MD	21227	BALTIMORE	USA	Allergy and Infectious Diseases Research	000	2	7/30/2021	COMPETING CONTINUATION	$999,996
														Subtotal = $999,996

Grand Total All Awards = $2,911,659

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A Serological Assay for Neutralizing Antitoxin Response in Patients with Clostridioides difficile Infection (Phase II)

Award Number: R44AI136176

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 01/20/2018

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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