USA flag logo/image

An Official Website of the United States Government

A Topical Non Steroidal Anti-inflammatory for Rosacea

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
Program Year/Program:
2011 / SBIR
Agency Tracking Number:
R44AI062034
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-050
Small Business Information
SIGNUM BIOSCIENCES
7 DEER PARK DR, STE H MONMOUTH JUNCTION, NJ -
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2011
Title: A Topical Non Steroidal Anti-inflammatory for Rosacea
Agency: HHS
Contract: 2R44AI062034-04
Award Amount: $2,975,892.00
 

Abstract:

DESCRIPTION (provided by applicant): Rosacea is a chronic dermatological condition characterized by flushing, erythema, papules, pustules, inflammatory nodules and telangiectasia. Although disease etiology remains unclear, skin inflammation has been identified as the main contributor to disease pathology. Isoprenylcysteine (IPC) analogs represent a novel class of topical anti-inflammatory compounds being developed as therapeutic agents for rosacea. As part of the Phase II SBIR project, Signum identified a lead investigational new drug (IND)-candidate, SIG990 which demonstrated strong efficacy in in vitro and in vivo models. Through pharmacokinetic and safety pharmacology studies, the preclinical safety profile for SIG990 was established. In the renewal application, we propose to continue SIG990's development path towards clinical application and FDA approval by conducting further safety assessment of drug product toxicity. Upon completion of the proposed aims, Signum will enter SIG990 into the Phase III clinical trials. PUBLIC HEALTH RELEVANCE: Rosacea is a common, chronic skin disorder afflicting people all around the world, including ~16 million Americans. Currently available treatments have yielded mixed results, often leaving patients with significant levels of facial redness and inflammatory lesions. Successful pharmaceutical development of topical IPC analog anti-inflammatories will provide an important additional, and potentially better, therapeutic option for people suffering from rosacea associated redness.

Principal Investigator:

Braham Shroot
732-329-6344
bshroot@signumbio.com

Business Contact:

Yulia Frenkel
732-329-6344
yfrenkel@signumbio.com
Small Business Information at Submission:

SIGNUM BIOSCIENCES
7 DEER PARK DR, STE H MONMOUTH JUNCTION, NJ -

EIN/Tax ID: 101061574
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No