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Novel Treatment for Traumatic Brain Injury

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS098903-01A1
Agency Tracking Number: R41NS098903
Amount: $417,267.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA16-303
Solicitation Year: 2016
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-09-28
Award End Date (Contract End Date): 2019-08-31
Small Business Information
San Diego, CA 92121-2734
United States
DUNS: 963248807
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (352) 870-3062
Business Contact
Phone: (858) 657-0918
Research Institution
FORT WORTH, TX 76107-2699
United States

 Nonprofit College or University

Traumatic brain injury TBI is a leading contributor to death and disability in the USA yet widely effective
treatments remain elusive and except for a lengthy program of rehabilitation no effective treatment for TBI is
available Therefore there is a critical need in new therapeutic approaches which can maximally preserve
brain tissue and facilitate functional recovery after TBI In the last two decades substantial efforts have been
invested in developing medicines for TBI but these efforts have not resulted in clinically efficacious therapies
These failures highlight the need for development of new therapeutic ideas and approaches for reducing
neuronal injury secondary to TBI Among possible strategies effective treatments with broad therapeutic
windows are likely to be the most valuable because of the unexpected events leading to brain trauma Our
data presented indicate that activation of nicotinic acetylcholine receptors nAChRs can significantly
reduce brain injury following TBI A novel therapeutic paradigm has been introduced that converts endogenous
choline ACh into potent therapeutic agents after brain trauma by inhibiting nAChR desensitization using
Type II positive allosteric modulators i e PAMIIs such as PNU Our data demonstrate that
PNU administered intravenously after controlled cortical impact CCI significantly reduces brain injury
and astrogliosis in rats and suggest that novel PAM II agents represent a therapeutic opportunity in TBI Our
efforts to discover novel entities has produced EPGN a compound with suitable potency in the
reactivation of nAChRs drug like characteristics and which demonstrates preliminary efficacy in a related
model of ischemic stroke A plan to test Epigen candidate PAM IIs in CCI models of TBI includes A Re
synthesis of novel candidate molecules with appropriate nAChR reactivation efficacy B a detailed
pharmacokinetic assessment of the PAM II candidates to design dosing schedules for efficacy studies and C
an evaluation of efficacy in the CCI model of TBI We expect to identify at least one PAM II with suitable
efficacy that may be progressed into pre clinical development or define criteria for the selection of lead PAM II
candidates Narrative
The objective is to discover and develop news drugs for the treatment of traumatic brain injury
a contributing factor to more than of all injury related deaths in the US

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

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