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Development of a novel anti-neuroinflammatory experimental therapeutic forepilepsy and Alzheimer's risk

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AG071062-01A1
Agency Tracking Number: R44AG071062
Amount: $450,367.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIA
Solicitation Number: PAS19-316
Timeline
Solicitation Year: 2019
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-01
Award End Date (Contract End Date): 2022-08-31
Small Business Information
105 AUBRUN ST
Newton, MA 02466-2524
United States
DUNS: 080178314
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 VICTOR SHIFRIN
 (617) 872-0639
 vshifrin@ic-rx.com
Business Contact
 VICTOR SHIFRIN
Phone: (617) 872-0639
Email: vshifrin@ic-rx.com
Research Institution
N/A
Abstract

ABSTRACT
Alzheimer’s disease and epilepsy are common age-related CNS disorders. Both Alzheimer’s disease and
epilepsy are more frequent in the elderly compared to any other age groups, and a history of epilepsy is a risk
factor for development of Alzheimer’s and related dementias. Further, patients with Alzheimer’s disease have
unprovoked seizures and epilepsy at a significantly higher rate than non-demented elderly. These public health
correlations are seen at the level of pathophysiology and manifested symptoms. For example, cognitive
impairment is a definitive aspect of Alzheimer’s disease, and recurrent epileptic seizures are associated with
cognitive impairment. Clearly, the increase in aging of the world’s population makes this comorbidity a major
concern. This proposal is focused on addressing a common pathophysiological mechanism in Alzheimer’s and
epilepsy – dysregulated proinflammatory cytokine production. Proinflammatory cytokine overproduction from
abnormally activated glia is a contributor to subsequent neurological damage and cognitive deficits in both
epilepsy/seizure disorders and in Alzheimer’s and related dementias. Despite advances in our understanding
of these molecular neuroinflammatory mechanisms underlying adverse neuronal sequelae in CNS disorders,
approved therapeutics that target this pathological process are lacking. ImmunoChem Therapeutics (ICT)
proposes to advance MW189, a novel small molecule candidate already in early phase clinical development,
having successfully completed phase 1a and phase 1b clinical trials. MW189 is a selective suppressor of
injury- and disease-induced proinflammatory cytokine overproduction associated with destructive glia
inflammation/synaptic dysfunction cycles and their long-term neurotoxic effects. This proposed Fast-Track
SBIR will deliver a phase 2a trial-ready portfolio for future first-in-patient (FIP) epilepsy treatment trials.
Specifically, we will: 1. Develop a commercial-scale version of a validated GMP clinical grade drug production
approach, produce a multi-Kg drug substance lot, and obtain its release for future patient clinical trials,
2. Obtain preclinical efficacy data for dosing information and the biological rationale required to support future
phase 2a proof-of-concept studies in patients with drug-resistant epilepsy, 3. Prepare required documents and
submit a phase 2 IND for a future clinical trial in patients with drug-resistant epilepsy.
Our milestones and their associated key tasks are organized as SBIR Phase I activities (year 01) and SBIR
Phase II activities (years 02-03). The Fast-Track structure will allow us to immediately move to SBIR Phase II
activities that flow seamlessly from preparation and technology transfer to essential milestones for a future FIP
safety trial including pharmacokinetics and a pharmacodynamic arm. Success will also further de-risk MW189
for future phase 2 trials in Alzheimer’s disease or other age-related disorders that involve dysregulated
neuroinflammation as a driver of disease progression.NARRATIVE
Alzheimer’s disease and epilepsy have an age-related association as well as shared disease
progression features, including brain inflammation and cognitive impairment. We developed a small
molecule experimental therapeutic, MW189, with potential to alter disease progression. This SBIR
project will facilitate progression to future first-in-patient clinical trials for MW189 which has exhibited
exceptional safety in recently completed first-in-human safety trials.

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

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