Anti-Scar Treatment for Deep Partial-Thickness (DPT) Burns
The current standard of care for deep partial-thickness (DPT)-burn injury remains supportive in nature, based on management of symptoms, with no prophylactic and drug therapies that address the scarring. Despite numerous clinical trials on potential therapies, no drug is approved by the FDA for the prophylaxis or treatment of wound scarring. DPT-burn injury is associated with significant long-term morbidity requiring costly corrective surgeries. Up to $7.5 billion is spent annually on treatment of burns in the United States, and much of this cost is related to treatment of the resulting scar and contracture (Marshall et al., 2018, PMID: 29392092}. Therefore, it is important to develop a therapy that will mitigate the life-long disability and rehabilitation costs associated with these post-injury conditions.
The goal of this program is to develop an anti-scar drug, pirfenidone (Pf), for the acute management and prophylactic treatment of deep partial-thickness (DPT) burn wounds that is conducive to operations in combat theatre as well as fixed medical facilities. Pf is a small molecule with a molecular weight of 185 g/mol that belongs to the chemical class of pyridinone with a formal name of pyridine (5-methyl-1-phenyl-2(1H)-pyridinone. Pf is an FDA-approved antifibrotic drug for treating pulmonary fibrosis. The USAISR repurposed Pf as a prophylactic agent and treatment primarily for DPT burn wounds, for reducing burn-induced hypertrophic scarring. Pf is safe and effective when administered orally at 2.4 grams per day for the treatment of pulmonary fibrosis.
The awarded project will accomplish the strategizing, planning, and implementation of manufacturing, IND-enabling studies, and early phase clinical trials of this anti-scarring drug prototype. The end goal of this program is to obtain U.S. Food and Drug Administration (FDA) approval for use of Pf in DPT burn-injured patients to enhance recovery, improve outcomes, and limit scarring.
The research project award recipients were selected from the Offerors who responded to MTEC’s Request for Project Proposals (19-05-AntiScar).
Title of Project: Anti-Scar Treatment for Deep Partial-Thickness Burns
Project Team: tesa Labtec GmbH; U.S. Army Institute of Surgical Research
Award Amount: $2,351,240
Project Duration: 2 years
Project Objective: The team will develop a planar dosage form for preventive anti-scar therapy through the completion of clinical trials. Our patient-centric approach aims to develop the most effective drug product for mitigating scar resulting from burn injuries, such as those occurring in war scenarios but also in everyday life, to meet the need of the wounded.