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A Potential New Drug for Depression

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
61069
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
MH063663
Solicitation Year:
N/A
Solicitation Topic Code:
NIMH
Solicitation Number:
N/A
Small Business Information
AZEVAN PHARMACEUTICALS, INC.
116 RESEARCH DRIVE BETHLEHEM, PA -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: A Potential New Drug for Depression
Agency: HHS
Contract: 3R44MH063663-08S1
Award Amount: $0.00
 

Abstract:

DESCRIPTION (provided by applicant): A Potential New Drug for Depression, an active SBIR Phase IIa award. The requested funds will allow additional characterization studies of three newly discovered mixed vasopressin 1a/1b antagonists, studies that were not part of the original application. These experiments will accelerate preclinical development of the novel mixed antagonists by facilitating identification of clinical candidates within this group of compounds. Arginine Vasopressin (AVP) antagonists rep resent a novel therapeutic class for the treatment of depression. The potential utility of these compounds has emerged from observations in depressed individuals, findings in animal models, and an understanding of changes in hypothalamic-pituitary-adrenal (HPA) axis regulation under chronic stress. The active Phase IIa award has two objectives. One is advancing the development of our lead clinical candidate, SRX246-HCl, through a Phase I Clinical Trial. SRX246 is a novel vasopressin 1a (V1a) receptor antago nist that had shown efficacy in preclinical animal models of depression and anxiety, good plasma bioavailability and CNS penetration following oral administration, a strong safety profile, and high affinity and selectivity for the target receptor, The deve lopment of this compound to date has been supported by SBIR Phase I, Phase II, and Phase IIa grants, the National Toxicology Evaluation program, a RAID grant, and Series A and Series B private sector investments. All IND-enabling toxicology and safety phar macology has been completed and an IND application is now under review at the FDA. Assuming approval, a Phase I Clinical Trial to establish safety and tolerability in humans will start in June or July, 2009. The second objective is continued development of back-up compounds, including additional V1a antagonists and mixed AVP 1a/1b antagonists. The Revision Application seeks additional support for preclinical studies that will accelerate clinical candidate identification among newly discovered back-up compou nds that are mixed V1a/V1b antagonists. Achieving these goals will enhance commercialization opportunities for Azevan by significantly advancing the likelihood of a partnership with a major pharmaceutical house and/or attracting additional private sector i nvestment. PUBLIC HEALTH RELEVANCE: The public health need for new pharmaceutical treatments for depression is well documented. Depression affects some 20 million Americans each year and carries a conservatively estimated annual total economic burde n of 125 billion. Existing drugs for depression are not uniformly effective and frequently have undesirable side effects. These limitations demonstrate that a new treatment approach through vasopressin receptor antagonism in the brain may offer significan t opportunities for improved outcomes with substantial societal benefit.

Principal Investigator:

Eve M. Damiano
6104191057
EDAMIANO@PTD.NET

Business Contact:

Simon G. Neal
6107583620
deitzkowitz@azevan.com
Small Business Information at Submission:

AZEVAN PHARMACEUTICALS, INC.
AZEVAN PHARMACEUTICALS, INC. 116 RESEARCH DRIVE BETHLEHEM, PA 18015

EIN/Tax ID: 142167269
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No