# Development of a stress kinase inhibitor therapeutic candidate for Alzheimer's Disease and related dementia

> **NIH NIH R44** · NEUROKINE THERAPEUTICS, LLC · 2020 · $500,000

## Abstract

There is an urgent need for disease modifying therapeutic approaches to Alzheimer’s disease, a major health
crisis that lacks disease modifying therapies. Neurokine Therapeutics (NKT) has a unique phase 2 ready clinical
asset, MW01-18-150SRM (= MW150), that represents a paradigm shift from the field’s dominant focus on
amyloid pathway targeted therapeutic candidates. MW150 has a unique portfolio of target recognition and
engagement, preclinical and clinical safety, and orally bioavailable drug exposure. The portfolio provides
rational explanations for some of the off-target effects, adverse pharmacology, and clinical challenges
encountered with prior art in the same therapeutic class, only one of which exhibited brain exposure.
Therefore, NKT seeks to rapidly fill a key gap for clinical development and future commercialization through
leveraging of the NIA SBIR program. Even with covid-19 pandemic delays, NKT anticipates an exceptional
phase 2a ready portfolio before the potential start date of a Fast Track SBIR investment by NIA. MW150
development was based on the perspective that Alzheimer’s and related diseases are disorders of
progressive synaptic dysfunction with a common neuroinflammation component. Therefore, our novel
approach to disease modifying therapeutic intervention was to target pathophysiology progression pathways,
with the neuroinflammation-synaptic dysfunction axis being an underlying element across multiple diseases.
The activity of the druggable serine/threonine protein kinase, p38alphaMAPK is increased in both neurons and
glia, raising the potential for efficacy through a novel pleiotropic pharmacological mechanism in which a single
molecular target drug is modulated in distinct cellular pathophysiology processes. Our specific aims are: Aim 1,
Generate, qualify and transfer to the Columbia University (CU) site drug product and placebo capsules.
Commercial scale drug substance is on hand, GMP drug product batch processes are established and CU has
an experienced and qualified Research Pharmacy; Aim 2A, Prepare, recruit, and conduct a phase 2a clinical
study of MW150. We will study 24 Alzheimer’s patients, randomized to once daily administration of test article
(MW150: 42 and 84 mg) or placebo (3:1 ratio); Aim 2B. Evaluate safety and pharmacokinetics and monitor
response biomarkers. Key milestones for SBIR part I deal with delivery of sufficient validated drug product to
the clinical site research pharmacy. Key milestones for part II deal with clinical treatment and evaluations of
safety and PK. Outcomes will fill a critical gap in MW150’s commercial and clinical development portfolio as
well as provide a firm foundation required for follow-on phase 2b studies in Alzheimer’s Disease. The potential
longer-term impact would be filling a void in safe, disease modifying therapeutics for a set of related neurologic
disorders.

## Key facts

- **NIH application ID:** 10157610
- **Project number:** 1R44AG071388-01
- **Recipient organization:** NEUROKINE THERAPEUTICS, LLC
- **Principal Investigator:** Wayne F Anderson
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $500,000
- **Award type:** 1
- **Project period:** 2020-09-30 → 2021-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157610

## Citation

> US National Institutes of Health, RePORTER application 10157610, Development of a stress kinase inhibitor therapeutic candidate for Alzheimer's Disease and related dementia (1R44AG071388-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10157610. Licensed CC0.

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