(Released 24 September 2018) The U.S. Department of Health and Human Services (HHS) will work with MediWound Ltd.of Yavne, Israel, to develop a new treatment for skin injuries caused by sulfur mustard, a potential terrorism threat. Currently, there are no treatments approved by the U.S. Food and Drug Administration for skin injuries caused by exposure to sulfur mustard.
“Mustard agents have been used in conflicts for over 100 years, yet there still are no approved treatments for the injuries they cause,” said Rick Bright, director of the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response. “At BARDA, we have a sense of urgency to develop innovative treatments to protect Americans against this and other national security threats.
Sulfur mustard was first used as a chemical weapon during World War I, and damages the skin, eyes, and lungs. Skin exposure to sulfur mustard can cause redness and blistering, similar to a second- or third-degree burn. The damage is slow to heal and can lead to scarring. Severe exposure can be fatal.
Under the three-year, $11.9 million contract with BARDA, MediWound will advance the development of NexoBrid as a treatment for chemically injured skin in adults and children exposed to sulfur mustard. NexoBrid is designed to remove chemically injured skin tissue in adults and children so that the wound can heal properly. The contract can be extended for as long as five additional years and up to $31 million in additional funding.
Studies under the contract include animal model development, optimization of NixoBrid treatment conditions, and efficacy studies in animals to support FDA approval.
NexoBrid has been shown in animal models to help reduce and heal wounds caused by sulfur mustard. In these studies, the treatment appeared to be easy-to-use and effective for early and selective removal of dead and damaged tissue (called eschar) from sulfur mustard skin wounds. Currently, surgery or specialized lasers are required to remove skin tissue damaged by sulfur mustard.
NexoBrid has received orphan drug status in the United States, European Union, and South Korea and is commercially licensed in the European Union, Israel, and Argentina for the removal of dead or damaged eschar in adults with deep partial and full thickness thermal burns.
The contract announced today builds on development work completed under a 2015 agreement between BARDA and MediWound.
BARDA continues to seek proposals for development of effective products to treat injuries caused by chemical agents, including new products or new indications for products already in clinical use. The products must be easy to use in a mass casualty situation, and safe and effective for all segments of the population. Proposals are accepted through the Broad Agency Announcement BARDA- BAA-18-100-SOL-00003 at the Federal Business Opportunities website, www.fbo.gov.
About HHS, ASPR and BARDA
HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.
For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit www.medicalcountermeasures.gov.
Released by the U.S. Department of Health & Human Services. Click here for source.