Development of a novel, regenerative therapy to reverse synapse loss in alzheimer's disease
Ended Project Grant Awarded Last action
- Award ID
- R44AG082648
- Recipient
-
Spinogenix, Inc. UEI G2JEUT716287
- Awarding agency
-
National Institute on Aging
National Institutes of Health, Department of Health and Human Services
- Obligated
- $4,414,120
Award facts
- Assistance listing
- 93.866 Aging Research
- Completion date
- Place of performance
- California, USA
Award details come from USAspending.gov.
Description
- Abstract
- The mission of the sbir program is to "encourage domestic small businesses to engage in federal research/research and development (r/r & d) that has the potential for commercialization." a mission of the NIA is to "support research on alzheimer's disease, and promote research on the etiology, treatment, and diagnosis of ad". The proposed development program is necessary to enable the filing and acceptance of an IND with the FDA, an early prelude to commercialization. The three specific aims of this development grant are: 1. GMP manufacture of an oral dosage form of SPG302, a novel synaptogenic molecule. 2. Conduct GLP safety pharmacology studies and conduct GLP IND-enabling toxicology studies in rats and beagle dogs for 4 weeks with SPG302 3. Prepare and submit a successful IND request to the FDA. The proposed studies are designed to optimize time and resources while moving step wise through safety tests, resulting in an IND submission (for phase 1 single ascending dose, multiple ascending dose and food interaction studies) within 24 months of the grant being funded. Spinogenix will work with a CRO to assemble the CMC, pharmacology and toxicology information and to prepare and submit an electronic IND to the FDA.
Transactions
| Action | Obligated | Date |
|---|---|---|
| Amendment | $0 | |
| Amendment | $1,574,900 | |
| Amendment | $0 | |
| Amendment | $0 | |
| Amendment | $1,419,610 | |
| Original award | $1,419,610 |
Quick answers
Who received award R44AG082648?
R44AG082648 was awarded to Spinogenix, Inc. by National Institute on Aging (National Institutes of Health) on June 1, 2023.
How much is award R44AG082648 worth?
$4,414,120 has been obligated on R44AG082648.
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