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PEPTIDE INHBITORS OF INFLUENZA ENTRY-FAST TRACK

Award Number: R44AI082778
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: 06/10/2009
PERIOD OF PERFORMANCE END DATE: 08/31/2012

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PEPTIDE INHBITORS OF INFLUENZA ENTRY-FAST TRACK - DESCRIPTION (provided by applicant): Between 10% and 20% of the United State population suffer from seasonal influenza each year. While most individuals recover from influenza in one to two weeks, the very young, the elderly and persons with chronic medical conditions can develop post-flu pneumonia and other lethal complications. The causative agent of influenza is influenza virus, a myxovirus that readily develops new strains through a process of reassortment and mutation of the segmented viral genome. Highly virulent strains of type A influenza virus can produce epidemics and pandemics. In recent years there has been emergence of a highly pathogenic strain of avian influenza A virus subtype H5N1. First detected in Thailand, Vietnam and other countries in Southeast Asia, this strain of "bird flu" has now spread too many parts of the world. Some variants are capable of directly infecting humans and other mammals, inflicting a high mortality rate. Human-to human spread of current highly-pathogenic bird flu strains does occur, but not yet at the efficiency necessary to trigger a pandemic in which millions or even tens of millions of people could die. In preliminary studies, we identified a remarkably effective peptide entry inhibitor that blocks infection by different strains of influenza A virus of the H1, H3 and H5 subtypes as well as influenza B viruses (IC50 in the nanomolar to picomolar range depending on assay conditions). This 16mer peptide, Flufirvitide-3, potently inhibited signs of influenza in ferrets, generally considered the best animal model for influenza. Peak titers of influenza virus in ferret nasal washes were reduced by over two logs and in the lungs by over six logs. The scope of work for this Phase I/Phase II Fast Track application includes preclinical IND-enabling activities that can potentially lead to human clinical trials and Emergency Use Authorization (EUA). In Specific Aim 1 (Phase I) optimal manufacturing, formulation, and delivery methods for Flufirvitide-3 will be developed and sufficient product for pharmacokinetic, bioavailability, toxicology and animal studies will be provided. In Specific Aim 2 challenge studies in ferrets using seasonal strains of influenza A and B viruses and highly pathogenic influenza a viruses will be performed to define the optimal formulation and delivery mechanism for Flufirvitide- 3. In Specific Aim 3 non-clinical pharmacokinetic and bioavailability analyses of Flufirvitide-3 will be performed and in Specific Aim 4 evaluation of the non-clinical safety profile of Flufirvitide-3 and related platform therapeutics will be initiated. PUBLIC HEALTH RELEVANCE: Because of the threat posed by influenza virus both to public health and as a potential agent of bioterrorism, developing therapeutics to control seasonal influenza and the increasing threat of pandemic influenza is one of this nation's highest priorities. Flufirvitide-3 is a potent inhibitor of infections by influenza virus in vitro and in the ferret model of influenza. We will develop a formulation and delivery regimen of Flufirvitide-3 that has broad-spectrum activity, high bioavailability in the respiratory tract, a simple dosing regimen, and safety in diverse populations for the prophylaxis and early treatment of seasonal and pandemic influenza.


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: 2011 ( Subtotal = $1,328,888 )
2011	2011	AUTOIMMUNE TECHNOLOGIES, LLC	1010 Common St Ste 1705	New Orleans	LA	70112	ORLEANS	USA	Allergy and Infectious Diseases Research	000	3	8/11/2011	NON-COMPETING CONTINUATION	$1,328,888
														Subtotal = $1,328,888

Issue Date FY: 2010 ( Subtotal = $1,305,089 )
2010	2010	AUTOIMMUNE TECHNOLOGIES, LLC	1010 Common St Ste 1705	New Orleans	LA	70112	ORLEANS	USA	Allergy and Infectious Diseases Research	000	2	8/30/2010	EXTENSION WITH OR WITHOUT FUNDS	$1,305,089
2010	2009	AUTOIMMUNE TECHNOLOGIES, LLC	144 ELKS PLACE SUITE 1402	NEW ORLEANS	LA	70112	ORLEANS	USA	Allergy and Infectious Diseases Research	001	1	8/30/2010	NEW	$0
														Subtotal = $1,305,089

Issue Date FY: 2009 ( Subtotal = $1,304,709 )
2009	2009	AUTOIMMUNE TECHNOLOGIES, LLC	1010 Common St Ste 1705	New Orleans	LA	70112	ORLEANS	USA	Allergy and Infectious Diseases Research	000	1	6/2/2009	NEW	$1,304,709
														Subtotal = $1,304,709

Grand Total All Awards = $3,938,686

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PEPTIDE INHBITORS OF INFLUENZA ENTRY-FAST TRACK

Award Number: R44AI082778

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: 06/10/2009

PERIOD OF PERFORMANCE END DATE: 08/31/2012

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