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Development of a lead cyclic-PDZ-Enhancer drug for Anxiety and Depression

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41MH118747-01A1
Agency Tracking Number: R41MH118747
Amount: $911,475.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA18-579
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-10
Award End Date (Contract End Date): 2021-07-31
Small Business Information
Barrington, RI 02806-2028
United States
DUNS: 080925349
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (401) 863-2574
Business Contact
Phone: (401) 316-2743
Research Institution
PROVIDENCE, RI 02912-9002
United States

 Nonprofit college or university

Major depressive disorder is a debilitating mood disorder that affects ~7% of US adults in their lifetime,
costing the U.S. economy more than $200 billion a year. Drugs that increase monoaminergic signaling
are the mainstay of depression therapy, but have a delayed onset of action and are only effective in
about 50% of affected patients. Aberrant brain-derived neurotrophic factor (BDNF) signaling has been
proposed to underlie the pathophysiology of major depressive disorder and Bipolar disorder.
We have developed a novel family of cyclic peptidomimetic compounds that potentiate the BDNF
pathways to produce rapid (within hours) antidepressant effects. Here, we propose a Phase I proof-of-
concept and feasibility study for the use of our patented new drug, CN2097, for treating depression.
There are three major goals that focus on preclinical efficacy. Aim 1 will test the stability of CN2097
analogues and evaluate toxicity. Aim 2 will evaluate the rapid and long-term effects of treatment
with CN2097 in mitigating depressive behaviors using two extensively validated models: Chronic
mild stress (CMS) and Chronic social defeat stress (CSDS). Aim 3 will examine the ability of
CN2097 to correct impairments in the cellular mechanisms of depression that include signaling,
neuronal atrophy and synaptic plasticity.Major Depressive Disorder affects over 16 million of the US population and represents a major cause of
disability worldwide. We have engineered a unique drug exerting rapid therapeutic effects on depression
pathways. Here, we propose a Phase I proof-of-concept and feasibility study for the use of our patented
new drug, CN2097, for treating depression. Results of this study will point to novel therapeutic treatment
for this devastating disorder.

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

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