The Path to SM-1997

DermDefense, Inc. is a medical countermeasure company founded upon the conviction that United States warfighters and their allies should have access to the most advanced medicine and medical practices available. We have developed a proprietary topical treatment (SM-1997) for sulfur mustard gas injuries.

Here is our timeline:

1917

First Use of Mustard Gas:
World War I

The Germans first used it against the British during World War I during the battle of Flanders, near Ypres, Belgium, in 1917. It was used by the Allies in 1918 and by the Italians in Ethiopia in 1936.

1988

Recent Usage

It has also been used recently in the Iran-Iraq War in 1984–1988 and by Iraq against its Kurdish minority in Halabjah in 1988.

2006

Research Begins

DermDefense team approached by Dr. John S. Graham PhD of the US Army Medical Reasearch Institute of Chemical Defense, Aberdeen Proving Ground, MD after hearing about the SM-1997 (Formulation developed by Sandra Chansler, Co-Founder of DermDefense, Inc.) and its ability to heal difficult wounds.

2008

Bioscience Meetings

Germany and Baltimore, MD

Sept 2009

Published in the Journal of Toxicology
Vol. 263 Issue 1

Dr. Graham’s study, funded by the National Institute of Health and the Department of Defense, to find a treatment program for the Management of Cutaneous Sulfur Mustard Gas Injuries, resulted in this article published in Toxicology. [Kehe, K., & Thiermann, H. (2009). Clinical Picture of Sulfur Mustard Poisoning. Toxicology.] 

Sept 2016

Sulfur Mustard Used

ISIS deployed sulfur mustard gas against US troops

July 2022

Obtained Orphan Drug Status

Sept 2022

Allowed Use of the Animal Rule

The FDA Animal Rule allows the FDA to rely on the animal trials instead of costly human trials, greatly expediting the approval process and dramatically reducing development costs.

Oct 2022

Secured a pathway to FDA utilizing the Animal Rule

2023 – 1st Quarter

Develop dose range study, debridement & preservative assay

2023 – 2nd Quarter

Complete Dose Range Study & Non-GLP Efficacy Study

2024 – 1st Quarter

Develop Validation Assay & Potency Assay Protocol

2024 – 4th Quarter

Develop Protocol for Preliminary Human Safety Study according to FDA guidelines

Develop GMP, FDA Regulatory and Inspection Pathway with Bovogen Biologicals Ltd

2025 – 3rd Quarter

Finish preliminary Human Safety Study

Start 13-week Toxicology Study with Alta Sciences to support safety

2025 – 4th Quarter

Complete Class B FDA application and meeting

Complete all GMP and all compliance issues with Bovogen to FDA

Complete GLP Efficacy studies and any additional FDA-required studies

Submit IND to FDA for NDA & PRV approval process