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HBI-002 to Treat Diabetic Retinopathy

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41EY033264-01
Agency Tracking Number: R41EY033264
Amount: $299,899.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NEI
Solicitation Number: PA20-265
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-01
Award End Date (Contract End Date): 2022-08-31
Small Business Information
2029 VERDUGO BLVD #125
Montrose, CA 91020-1626
United States
DUNS: 078631704
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (818) 445-5890
Business Contact
Phone: (818) 445-5890
Research Institution
1120 15TH STREET
AUGUSTA, GA 30912-0004
United States

 Nonprofit College or University

Diabetic retinopathy (DR) is a neurovascular complication of diabetes mellitus and the leading cause of
blindness in working age adults and elderly, affecting approximately 4.2 million diabetes patients in the US, of
which 655,000 have vision-threatening DR. There is an urgent need for the development of additional
approaches to prevent and treat diabetic retinopathy, as the current therapeutic interventions have limited
efficacy and substantial drawbacks. In multiple preclinical studies, we and others have demonstrated the
cytoprotective properties of low dose carbon monoxide (CO) in various disease states, including in ischemia-
associated diseases such as DR
To date, inhaled CO gas (iCO) and CO bound to carrier molecules (CORMs) have been the modalities of
choice in the majority of animal and in all the clinical studies carried out to study the potential benefit of low
dose CO. However, iCO and CORMS are not expected to be pharmaceutically acceptable and viable
therapeutic options due to, with iCO, the risk of inadvertent exposure from the presence of compressed CO
cylinders as well as difficulties in controlling dosing and, with CORMs, carrier molecule toxicology, stability, and
CO release characteristics that have proven to be a substantial barrier to development. The objective of the
proposed project is to investigate HBI-002, a novel oral CO drug product, to prevent and treat DR.
The safety and tolerability of CO has been demonstrated in 25 successful Phase 1 and 2 clinical studies by
others in other indications supported by well-defined preclinical data sets that led to approval by the FDA for
human testing. HBI-002 comprises an oral formulation containing precise amounts of CO that are not bound to
a carrier molecule (i.e. not a CORM). Preclinical in vivo pharmacokinetic studies demonstrated proof-of-
concept feasibility, tolerability, and bioavailability. The next step in development is to demonstrate that HBI-002
is effective in clinically relevant animal models of DR and to better understand the potential mechanism(s) of
action. Based upon the substantial literature of CO in protecting against ischemia-associated and
ophthalmologic disease, our central hypothesis that will be tested in this project is: HBI-002 will prevent DR
by reducing oxidative stress and inflammation.PROJECT NARRATIVE
This proposal is intended to support research evaluating whether HBI-002, an oral carbon monoxide (CO)
therapeutic, can improve outcomes in animal models of diabetic retinopathy (DR). If successful, the project will
provide proof-of-concept for further development of HBI-002 in DR as a promising therapeutic to improve
outcomes in this devastating condition.

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

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