Atopic dermatitis is a chronic dermatological condition afflicting mostly infants and young children. Current treatments are associated with a wide range of side effects therefore development of novel therapeutic agents that are efficacious and have an improved safety profile is needed. Although disease etiology has yet to be fully understood, skin inflammation is known to be critically involved in the disease pathology. Signum has identified novel potent topical anti-inflammatory agents called isoprenylcysteines (IPCs) with no detectable adverse affects. The proposed Phase II research plan will identify one lead compound and one backup for preclinical development and will establish the analytical methods, process development and formulation necessary to conduct IND-enabling studies (e.g. pharmacokinetic, toxicology and safety pharmacology determination). Together, the data generated from these studies will allow Signum to prepare and submit an IND for treatment of atopic dermatitis.

Public Health Relevance

Atopic dermatitis is a chronic pruritic skin disorder afflicting mainly children under the age of five. Current treatments, although efficacious in reducing symptoms are associated with adverse-effects. Successful pharmaceutical development of topical IPC analog anti-inflammatories will provide an important additional, and potentially better, therapeutic option for people suffering from atopic dermatitis.

Agency
National Institute of Health (NIH)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AR058020-03
Application #
8738405
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Cibotti, Ricardo
Project Start
Project End
Budget Start
Budget End
Support Year
3
Fiscal Year
2014
Total Cost
Indirect Cost
Name
Signum Biosciences
Department
Type
DUNS #
City
Monmouth Junction
State
NJ
Country
United States
Zip Code
08852