A Topical Non Steroidal Anti-inflammatory for Rosacea

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 2R44AI062034-04
Agency Tracking Number: R44AI062034
Amount: $2,975,892.00
Phase: Phase II
Program: SBIR
Awards Year: 2011
Solitcitation Year: 2011
Solitcitation Topic Code: NIAID
Solitcitation Number: PA10-050
Small Business Information
SIGNUM BIOSCIENCES
7 DEER PARK DR, STE H, MONMOUTH JUNCTION, NJ, -
Duns: 144196354
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 BRAHAM SHROOT
 (732) 329-6344
 bshroot@signumbio.com
Business Contact
 YULIA FRENKEL
Phone: (732) 329-6344
Email: yfrenkel@signumbio.com
Research Institution
 Stub
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.

* information listed above is at the time of submission.

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