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Low Dose Oral Carbon Monoxide Therapeutic for Virus-Induced Lung Injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI164948-01A1
Agency Tracking Number: R41AI164948
Amount: $599,788.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-262
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-08-11
Award End Date (Contract End Date): 2024-07-31
Small Business Information
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
BOSTON, MA 02215-5400
United States

 Domestic Nonprofit Research Organization

There is an urgent need for the development of new approaches to treat patients suffering from pulmonary injury
from viral infections, as demonstrated by the severe impact of COVID-19, which is a global pandemic that, at the
time of writing, is estimated have impacted approximately 50 million people in the United States, leading to
morbidity, substantial hospital and intensive care utilization, and mortality. In multiple preclinical studies, we and
others have defined the therapeutic potential of low dose exogenous carbon monoxide (CO) in acute lung injury,
including in virus-induced pulmonary injury, by reducing inflammation and promoting viral clearance.
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, and the safety and tolerability of CO has been demonstrated
in 23 successful Phase 1 and 2 clinical studies, including in patients with pulmonary conditions such as ARDS
and COPD. However, iCO and CORMS are not expected to be pharmaceutically acceptable and viable
therapeutic options in COVID patients due to, for iCO, the risk of accidental inhalation exposure from the
presence of compressed CO gas cylinders and imprecise dosing, especially in COVID-19 patients that have
limited and variable respiratory function, and, for CORMs, problematic release kinetics and toxicological
concerns with carrier molecules. The objective of the proposed project is to investigate HBI-002, a novel oral low
dose CO drug product that enables the use of low dose CO in viral infections associated with acute pulmonary
injury, such as COVID-19.
HBI-002 is an oral liquid drug product containing CO. An IND is in place for HBI-002, with a Phase 1 clinical trial
in healthy volunteers planned in 2022. The next step in development is to demonstrate that HBI-002 is effective
in clinically relevant animal models of viral acute lung injury as has been shown with other forms of CO and to
better understand the potential mechanism(s) of action. Based upon the substantial literature of CO in acute lung
injury and our and others findings in virus-induced lung injury, our central hypothesis that will be tested in this
project is: HBI-002 modulates the immune response to regulate inflammation and improve viral clearance
in experimental models of virally induced lung injury sufficiently to warrant a Phase 2 clinical trial.

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

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