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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44AI062034-04
Application #
8196282
Study Section
Special Emphasis Panel (ZRG1-MOSS-D (12))
Program Officer
Prograis, Lawrence J
Project Start
2004-07-01
Project End
2014-07-31
Budget Start
2011-08-01
Budget End
2012-07-31
Support Year
4
Fiscal Year
2011
Total Cost
$1,007,031
Indirect Cost
Name
Signum Biosciences
Department
Type
DUNS #
144196354
City
Monmouth Junction
State
NJ
Country
United States
Zip Code
08852