Israel’s MediWound Ltd., a biotech firm that makes burn and wound treatments, said that it has received a new contract for up to $43 million from the US Biomedical Advanced Research and Development Authority (BARDA) to adapt its lead product, a gel based on pineapple enzymes for the treatment of burns, to treat mustard gas injuries in case of a mass casualty event.
Sulfur mustard is a chemical warfare agent typically dispersed as a fine mist of liquid droplets that causes thermal burns and skin injuries.
The contract will give Yavne, Israel-based MediWound some $12 million in funding to support research and development for adapting its NexoBrid product to treat mustard gas injuries. The up to eight-year contract also contains options for additional funding of up to $31 million for additional development activities including animal studies and necessary US Food and Drug Administration licenses, MediWound said in a statement on Tuesday.
MediWound has already received some $132 million in funding from BARDA for the development of NexoBrid. BARDA, which is within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services, is in charge of the development and acquisition of vaccines, drugs, therapies and diagnostic tools for public health medical emergencies.
The new contract is an “endorsement” of MediWound’s technology by an additional department in BARDA, and the firm will collaborate with the US body to develop NexoBrid for this new indication as part of the US efforts to prepare for mass casualty events, Gal Cohen, president and chief executive officer of MediWound, said in the statement.
“Ten decades of research has not yet produced an approved treatment for sulfur mustard skin injury,” he added. “Based on promising data from animal studies presented at the 2017 European Burn Association conference, NexoBrid has the unique potential to help victims of mass casualty events involving this chemical warfare agent, who otherwise would have to undergo radical surgical removal of contaminated skin.”
Earlier this year, the FDA agreed that the development of the new drug can be tested on animals only, as it is neither ethical nor feasible to conduct human trials with chemical warfare agents. Under the FDA’s Animal Rule, the US agency “may grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans,” Cohen said. “Now with the non-dilutive funding awarded by BARDA, we can move forward with animal trials in an effort to develop a non-surgical treatment option for sulfur mustard victims.”
MediWound develops and produces therapies based on proteolytic enzymes which it extracts from the stem of the pineapple plant. NexoBrid, the company’s first product, is the first approved pharmacological treatment for the removal of scab tissue that is associated with severe burns. Typically, this tissue — removal of which is essential to speed up healing and prevent infections — is removed surgically.
NexoBrid has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean and Russian health ministries. The medication has been approved for use to remove dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns.
The drug is considered a new method of burn care management, and clinical trials have demonstrated with statistical significance its ability to non-surgically and rapidly remove eschar earlier and without harming viable tissues, MediWound said.
MediWound’s second product, EscharEx, is a topical biological drug being developed for debridement — the removal of dead or infected tissue — of chronic and other hard-to-heal wounds, the company said. EscharEx contains the same proteolytic enzyme technology as NexoBrid.
In May, the company, whose shares are traded on the Nasdaq, said it has hired an investment bank to help it with negotiations to sell NexoBrid. In 2017, MediWound sales jumped 60% to $2.5 million, and net loss for the year totaled $22 million.