# IND Enabling Studies for a Novel Mas Receptor Agonist for Treatment of Cognitive Impairment in Patients at Risk for Alzheimer's Disease Related Dementia

> **NIH NIH U01** · UNIVERSITY OF ARIZONA · 2022 · $766,972

## Abstract

PROJECT SUMMARY
The purpose of this request for an administrative supplement is to cover the increased cost of GMP peptide
manufacturing and the increased cost of the in-vivo and in-vitro toxicology studies that will occur in year 2. With
regards to manufacturing, since the original submission of this U01 proposal, Polypeptide, our Peptide
manufacturing CRO, the cost of a 500gram GMP batch of PNA5 ($970/gram plus stability testing, CMC
documentation, and final fill and finish) is now $786,000 vs our original budget of $525,000 for 150 grams
($2500/gram plus stability testing, CMC documentation). This increased batch size is required for our planned
extended 21-day repeated dose formal toxicity studies planned in Yr 3 and will also be enough to complete our
planned Phase 1a/b studies in humans, thus eliminating the need to produce a second GMP batch for the
planned first in human study. The cost difference will be $261,000. This will ultimately save both time and
money by not requiring a 2nd GMP batch prior to first-in-human studies batch and a significant $/gram savings.
Regarding the 7-day MTD toxicology studies in rat and dog and in vitro assays (hERG, chromosome assay,
AMES), we have been able to accelerate the timing of these studies and now plan to have these completed in
Year 2. In the original proposal, the original quotes our original vendor (MPI) totaled $452,800. Since then, that
vendor was acquired by Charles River and those same studies are now costing $691,456. The cost difference
is $238,656. We have included an itemized cost comparison between the original quote and the new quote
below. Thus, for Year 2, we are requesting an additional $499,656 in direct costs to cover the increased
manufacturing costs and for the increase in-vivo and in-vitro toxicology costs.

## Key facts

- **NIH application ID:** 10437202
- **Project number:** 3U01AG066623-03S2
- **Recipient organization:** UNIVERSITY OF ARIZONA
- **Principal Investigator:** Meredith Hay
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $766,972
- **Award type:** 3
- **Project period:** 2020-04-15 → 2024-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10437202

## Citation

> US National Institutes of Health, RePORTER application 10437202, IND Enabling Studies for a Novel Mas Receptor Agonist for Treatment of Cognitive Impairment in Patients at Risk for Alzheimer's Disease Related Dementia (3U01AG066623-03S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10437202. Licensed CC0.

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