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 two novel potent topical anti-inflammatory agents (lead compound - SIG1451, backup compound ? SIG1456) called isoprenylcysteines (IPCs) with no detectable adverse affects. The proposed Phase IIB research plan will enable the filing of an investigational new drug (IND) application for the first in human trials in AD. In addition this grant proposal will buttress Post-IND clinical efforts by completing additional juvenile safety and continue drug substance and drug product development for Phase II clinical trials.

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)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44AI132065-06
Application #
9624402
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Minnicozzi, Michael
Project Start
2017-02-14
Project End
2020-01-31
Budget Start
2019-02-01
Budget End
2020-01-31
Support Year
6
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Signum Biosciences
Department
Type
DUNS #
144196354
City
Monmouth Junction
State
NJ
Country
United States
Zip Code
08852