Xvir-110 an ultra-long-acting insti for HIV pre-exposure prophylaxis in IND-enabling studies
Ended Project Grant Awarded Last action
- Award ID
- R44AI179564
- Recipient
-
Exavir Therapeutics Inc. UEI EV9JGJL7VVF9
- Awarding agency
-
National Institute of Allergy and Infectious Diseases
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,099,950
Award facts
- Assistance listing
- 93.855 Allergy and Infectious Diseases Research
- Completion date
- Place of performance
- San Francisco, CA 94111, USA
Award details come from USAspending.gov.
Description
- Abstract
- While there are now successful treatment regimens and prevention strategies for people living with HIV/aids, the HIV pandemic remains a public health crisis in the united states and worldwide, with nearly 40,000 new infections each year in the US alone. To prevent the spread of HIV in vulnerable populations, the US preventive services task force has recommended HIV pre-exposure prophylaxis (prep) for all adults and adolescents at risk of HIV acquisition. Although current antiretroviral drug regimens are potent and well-tolerated, enabling the life-long suppression of HIV-1 infection and the prevention of HIV-1 infection in individuals at high risk, compliance rates are low. Long-acting antiretroviral drugs (arvs) have the potential to improve drug adherence, reduce viral transmission, prevent new infections, and limit the emergence of viral drug resistance and systemic toxicities. However, the key challenge for using long-acting arvs is to extend the dosing interval to reduce the pressure on the healthcare facilities, which are set up for every six-month clinic visits. This challenge likely reduces compliance, particularly in the prep setting. Poor compliance has been shown to increase infection rates and the possibility of developing drug resistance. Exavir therapeutics, INC has created an "ultra" long- acting ARV by developing an ultra-long-acting, nanoformulated injectable prodrug to overcome this challenge. Building upon our phase i equivalent data, we proposed in this direct-to-phase II sbir project to further develop our drug by 1) completing the chemistry, manufacturing, and controls development of the drug substance and drug product, 2) completing IND-enabling studies, and 3) obtaining FDA IND approval. Upon completion, this direct-to-phase II sbir project will enable the submission of an IND to the FDA for approval and preparation of our phase i first-in-human clinical trial. If successful, the impact of our novel "ultra" long-acting ARV on HIV-1 prevention and quality of life for individuals already infected with HIV-1 will be far-reaching in real-world settings.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $1,000,000 | |
| Amendment | $1,000,000 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $1,049,975 | |
| Original award | $1,049,975 |
Quick answers
Who received award R44AI179564?
R44AI179564 was awarded to Exavir Therapeutics Inc. by National Institute of Allergy and Infectious Diseases (National Institutes of Health) on August 17, 2023.
How much is award R44AI179564 worth?
$4,099,950 has been obligated on R44AI179564.
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