FDA Clears Development Pathway for NexoBrid for Sulfur Mustard Injuries

MediWound (Nasdaq:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that following a meeting with the U.S. Food and Drug Administration (FDA), the Agency agreed that MediWound’s development plan for NexoBrid for the debridement of skin injuries inflicted by Sulfur Mustard (a chemical warfare agent, typically dispersed as a fine mist of liquid droplets) in adults and children, would be in accordance with the Animal Rule, as it is neither ethical nor feasible to conduct human trials with chemical warfare agents.

As quoted in the press release:

The FDA also agreed that single animal species trials would suffice, subject to adequate safety and efficiency data from the planned studies. In addition, the FDA agreed to rely on the existing Chemistry, Manufacturing and Control (CMC) information already available for NexoBrid by way of cross-reference to the existing NexoBrid IND for burns.

“We are excited about this project, as it leverages our existing enzymatic technology platform to additional indications and takes advantage of the advanced stage of development of NexoBrid, a highly effective burn care product. Ten decades of research has not produced an effective treatment for Sulfur Mustard skin injury, except for radical surgical removal of the contaminated skin. An effective non-surgical debridement agent could play a major role in a mass casualty incident involving victims exposed to Sulfur Mustard and suffering from a serious and life threating condition,” stated Gal Cohen, President and Chief Executive Officer of MediWound. “Based on promising data from animal studies presented at the 2017 European Burn Association conference, indicating the potential benefit of using NexoBrid for the treatment of such Sulfur Mustard injuries, and following the meeting with the FDA, we will seek to collaborate on this program with relevant governmental entities.”

Click here to read the full press release.